Label: ACETAMINOPHEN ORAL SOLUTION- acetaminophen oral solution solution
DIPHENHYDRAMINE HYDROCHLORIDE- diphenhydramine hydrochloride liquid
MILK OF MAGNESIA- magnesium hydroxide suspension

  • NDC Code(s): 0904-6738-70, 0904-6739-71, 0904-6740-70, 0904-6741-72, view more
    0904-6820-76, 0904-6840-72, 0904-6846-73
  • Packager: Major Pharmaceuticals
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: OTC monograph not final

DISCLAIMER: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

Drug Label Information

Updated June 3, 2019

If you are a consumer or patient please visit this version.

  • Acetaminophen Oral Solution 160 mg/ 5 mL Unit Dose Cup Major Pharmaceutical

    APAP 5 mL LidUNIT TRAYNDC 0904-6738-70

    Acetaminophen

    Oral Solution, USP

    160 mg / 5 mL

    Delivers 5 mL

    See Insert

    For Institutional Use Only

    MAJOR PHARMACEUTICALS

    Livonia, MI 48152

    Sugar Free - Dye Free - Alcohol Free

    Acetaminophen 160 mg / 5 mL Unit Dose Cup
    Major Pharmaceuticals

    Directions

    Do not use more than directed Shake well before use

    Age (yr)

    Dose (mL)

    adults

    • take 20 mL (640 mg) every 4 to 6 hours
    • not to exceed 6 doses in a 24-hour period
    • do not use more than 10 days unless directed by a doctor

    under 18 years of age

    • ask a doctor

    Acetaminophen 160 mg / 5 mL
    Major Pharmaceuticals

    Keep out of reach of children.

    Overdose warning: taking more than the recommended dose (overdose) may cause liver damage. In case of overdose, get medical help or contact Poison Control Center (1-800-222-1222) right away. Quick medical attention is critical for adults as well as for children even if you do not notice any signs or symptoms.

    Acetaminophen 160 mg / 5 mL
    Major Pharmaceuticals

    Do not use

    - with any other drug containing acetaminophen (prescription or nonprescription). If you are not sure whether a drug contains acetaminophen, ask a doctor or pharmacist.

    - if you are allergic to acetaminophen or any other inactive ingredients in this product

    ____________________________________________________________________________

    Ask a doctor before use if the user

    - has liver disease - is pregnant or breast-feeding ____________________________________________________________________________

    Ask a doctor or pharmacist before use if you are taking the blood thinning drug warfarin

    ____________________________________________________________________________

    Stop use and ask a doctor if

    - pain gets worse or lasts more than 10 days - new symptoms occur

    - fever gets worse or lasts more than 3 days - redness or swelling is present

    These could be signs of a serious condition

    Acetaminophen 160 mg / 5 mL
    Major Pharmaceuticals

    Inactive ingredients cherry flavor, citric acid, glycerin, methylcellulose, microcrystalline cellulose, propyl paraben, propylene glycol, purified water, sodium benzoate, sorbitol, sucralose, xantham gum

    Acetaminophen 160 mg / 5 mL
    Major Pharmaceuticals

    Uses temporarily relieves minor aches and pains due to:

    • minor pain of arthritis
    • muscular aches
    • backache
    • premenstrual and menstrual cramps
    • the common cold
    • headache
    • toothache
    • temporarily reduces fever

    Acetaminophen 160 mg / 5 mL
    Major Pharmaceuticals

    Active ingredient (in each 5 mL cup) ­ Purpose Acetaminophen USP 160 mg…………………………..………………..Pain reliever / fever reducer

    Acetaminophen 160 mg / 5 mL
    Major Pharmaceuticals

    Pain reliever / fever reducer

    Acetaminophen 160 mg / 5 mL
    Major Pharmaceuticals

    Other information

    - store at 20°-25°C (68°-77°F). Avoid excessive heat 40°C (104°F)

    - protect from excessive moisture - do not use if lid seal is open or damaged

    - sugar free, dye free, alcohol free - see bottom of cup for lot number and expiration date

    Acetaminophen 160 mg / 5 mL
    Major Pharmaceuticals

    IFU Acetaminophen 5 mL

    Close
  • Diphenhydramine HCl 12.5 mg/ 5 mL Cups

    Tray for 5 mL and 10 mL CupsDiphen HCL 12.5 mg - 5ML Approved LidNDC 0904-6740-70

    Diphenhydramine HCl

    Oral Solution, USP

    12.5 mg/5 mL

    Antihistamine - Delivers 5 mL

    See Insert

    For Instituional Use Only

    MAJOR PHARMACEUTICALS

    Livonia, MI 64152

    Sugar Free - Dye Free - Alcohol Free

    Diphenhydramine HCl 12.5 mg/5 mL
    Major Pharmaceuticals - Institutional Use Only

    Directions

    • Use the following dosage guidelines when using this product

    Age (yr)

    Dose (mL)

    adults and children 12 years and over

    take 10 mL every 4 to 6 hours; not more than 60 mL in 24 hours

    children 6 years to under 12 years

    take 5 mL every 4 to 6 hours; not more than 30 mL in 24 hours

    children under 6 years

    ask a doctor

    Cup Lid Graphic 5 mL

    Diphenhydramine HCl 12.5 mg/5 mL
    Major Pharmaceuticals - For Institutional Use Only

    Warnings

    Do not use

    in neonates or premature infants

    if pregnant or breast-feeding

    if hypersensitive to diphenhydramine HCl and other similar antihistamines

    with any other product containing diphenhydramine, even one used on skin

    to make a child sleepy

    ___________________________________________________________________

    Ask a doctor before use if you have

    glaucoma a breathing problem such as emphysema or chronic bronchitis

    a sodium restricted diet trouble urinating due to an enlarged prostate gland

    ___________________________________________________________________

    Ask a doctor or pharmacist before use if

    taking tranquilizers or sedatives

    ___________________________________________________________________

    When using this product

    marked drowsiness may occur avoid alcoholic drinks

    alcohol, sedatives, and tranquilizers may increase drowsiness

    be careful when driving a motor vehicle or operating machinery

    excitability may occur, especially in children

    ___________________________________________________________________

    Diphenhydramine HCl 12.5 mg/5 mL
    Major Pharmaceuticals - for Institutional Use Only

    Inactive ingredients cherry flavor, citric acid, glycerin, monoammonium glycyrrhizinate, poloxamer 407, purified water, sodium benzoate, sodium chloride, sodium citrate, sucralose

    Diphenhydramine HCl 12.5 mg/5 mL
    Major Pharmaceuticals - For Institutional Use Only

    Uses temporarily relieves these symptoms due to hay fever or other upper respiratory allergies: • runny nose • sneezing • itchy, watery eyes • itchy throat

    Diphenydramine HCl 12.5 mg/ 5 mL
    Major Pharmaceutical - For Institutional Use Only

    Keep out of reach of children.

    In case of overdose, get medical help or contact a Poison Control Center right away. (1-800-222-1222)

    Diphenhydramine HCl 12.5 mg/ 5 mL
    Major Pharmaceuticals - For Intitutional Use Only

    Antihistamine

    Diphenhydramine HCl 12.5 mg/ 5 mL
    Major Pharmaceuticals - For Institutional Use Only

    Active ingredient (in each 5 mL cup) Purpose Diphenhydramine HCl USP 12.5 mg..………………………………………Antihistamine

    Diphenhydramine HCl 12.5 mg/5 mL
    Major Pharmaceuticals - For Institutional Use Only

    Other information

    • each 5 mL contains: sodium 15 mg
    • store at 20-25°C (68-77°F)
    • protect from excessive moisture
    • do not use if lid seal is open or damaged
    • sugar free, dye free, alcohol free
    • see bottom of cup for lot number and expiration date

    Diphenhydramine HCl 12.5 mg/ 5 mL
    Major Pharmaceuticals - IFU - For Institutional use Only

    Diphen 5mL IFU Rev 2 final Proof

    Product Insert

    Diphenhydramine HCl Oral Solution, USP

    NDC 0904-6740-70

    10 x 5 mL Unit Dose Cups

    Active ingredient (in each 5 mL cup) Purpose Diphenhydramine HCl USP 12.5 mg..………………………………………Antihistamine

    Uses temporarily relieves these symptoms due to hay fever or other upper respiratory allergies:

    • runny nose
    • sneezing
    • itchy, watery eyes
    • itchy throat

    Warnings

    Do not use

    • in neonates or premature infants
    • if pregnant or breast-feeding
    • if hypersensitive to diphenhydramine HCl and other similar antihistamines
    • with any other product containing diphenhydramine, even one used on skin
    • to make a child sleepy

    Ask a doctor before use if you have

    • glaucoma
    • a breathing problem such as emphysema or chronic bronchitis
    • a sodium restricted diet
    • trouble urinating due to an enlarged prostate gland

    Ask a doctor or pharmacist before use if

    • taking tranquilizers or sedatives

    When using this product

    • marked drowsiness may occur
    • avoid alcoholic drinks
    • alcohol, sedatives, and tranquilizers may increase drowsiness
    • be careful when driving a motor vehicle or operating machinery
    • excitability may occur, especially in children

    Keep out of reach of children.

    In case of overdose, get medical help or contact a Poison Control Center right away. (1-800-222-1222)

    Other information

    • each 5 mL contains: sodium 15 mg
    • store at 20-25°C (68-77°F)
    • protect from excessive moisture
    • do not use if lid seal is open or damaged
    • sugar free, dye free, alcohol free
    • see bottom of cup for lot number and expiration date

    Inactive ingredients cherry flavor, citric acid, glycerin, monoammonium glycyrrhizinate, poloxamer 407, purified water, sodium benzoate, sodium chloride, sodium citrate, sucralose

    Directions

    Use the following dosage guidelines when using this product

    Age (yr) Dose (mL)

    adults and children 12 years and over take 10 mL every 4 to 6 hours; not more than 60 mL in 24 hours

    children 6 years to under 12 years take 5 mL every 4 to 6 hours; not more than 30 mL in 24 hours

    children under 6 years ask a doctor

    Questions or comments?

    Call 1-800-616-2471

    Re-order No. 700900

    MAJOR® PHARMACEUTICALS

    17177 N Laurel Park Dr., Suite 233

    Livonia, MI 48152

    Close
  • Diphenhydramine HCl 25 mg / 10 mL Cups

    Tray for 5 mL and 10 mLl CupsDiphen HCl 10 mL lidNDC 0904-6741-72

    Diphenhydramine HCl

    Oral Solution, USP

    25 mg/10 mL

    Antihistamine - Delivers 10 mL

    See Insert

    For Instituional Use Only

    MAJOR PHARMACEUTICALS

    Livonia, MI 64152

    Sugar Free - Dye Free - Alcohol Free

    Diphenhydramine HCl 25 mg/ 10 mL
    Major Pharmaceuticals - for Instutional use Only

    Directions

    Use the following dosage guidelines when using this product

    Age (yr) Dose (mL)

    adults and children 12 years and over take 10 mL every 4 to 6 hours; not more than 60 mL in 24 hours

    children 6 years to under 12 years ask a doctor

    Diphenhydramine HCl 10 mg/ 10 mL
    Major Pharmaceuticals - For Institutional Use Only

    Warnings

    Do not use

    • in neonates or premature infants

    • if pregnant or breast-feeding

    • if hypersensitive to diphenhydramine HCl and other similar antihistamines

    • with any other product containing diphenhydramine, even one used on skin

    • to make a child sleepy

    ___________________________________________________________________

    Ask a doctor before use if you have

    • glaucoma • a breathing problem such as emphysema or chronic bronchitis

    • a sodium restricted diet • trouble urinating due to an enlarged prostate gland

    ___________________________________________________________________

    Ask a doctor or pharmacist before use if

    • taking tranquilizers or sedatives

    ___________________________________________________________________

    When using this product

    • marked drowsiness may occur • avoid alcoholic drinks

    • alcohol, sedatives, and tranquilizers may increase drowsiness

    • be careful when driving a motor vehicle or operating machinery

    • excitability may occur, especially in children

    Diphenhydramine HCl 25 mg/ 10 mL
    Major Pharmaceuticals - For Institutional Use Only

    Inactive ingredients cherry flavor, citric acid, glycerin, monoammonium glycyrrhizinate, poloxamer 407, purified water, sodium benzoate, sodium chloride, sodium citrate, sucralose

    Diphenhydramine HCl 10 mg / 10 mL
    Major Pharmaceuticals - For Institutional Use Only

    Uses temporarily relieves these symptoms due to hay fever or other upper respiratory allergies: • runny nose • sneezing • itchy, watery eyes • itchy throat

    Diphenhydramine HCl 25 mg/ 10 mL
    Major Pharmaceuticals - For Institutional use Only

    Keep out of reach of children.

    In case of overdose, get medical help or contact a Poison Control Center right away. (1-800-222-1222)

    Diphenhydramine HCl 25 mg/ 10 mL
    Major Pharmaceuticals - For Institutional Use Only

    Antihistamine

    Diphenhydramine HCl 25 mg/ 10 mL
    Major Pharmaceuticals - For Institutional Use Only

    Active ingredient (in each 10 mL cup) Purpose Diphenhydramine HCl USP 25 mg..………………………………………Antihistamine

    Diphenhydramine HCl 25 mg/ 10 mL
    Major Pharmaceuticals - For Institutional Use Only

    • each 10 mL contains: sodium 30 mg

    • store at 20-25°C (68-77°F)
    • protect from excessive moisture
    • do not use if lid seal is open or damaged
    • sugar free, dye free, alcohol free
    • see bottom of cup for lot number and expiration date

    Diphenhydramine HCl 25 mg/ 10 mL
    Major Pharmaceuticals - IFU - For Institutional Use Only

    Diphen 10 mL IFU Rev2 final Proof roduct Insert

    Diphenhydramine HCl Oral Solution, USP

    NDC 0904-6741-72

    10 x 10 mL Unit Dose Cups

    Active ingredient (in each 10 mL cup) Purpose Diphenhydramine HCl USP 25 mg..………………………………………Antihistamine

    Uses temporarily relieves these symptoms due to hay fever or other upper respiratory allergies:

    • runny nose
    • sneezing
    • itchy, watery eyes
    • itchy throat

    Warnings

    Do not use

    • in neonates or premature infants
    • if pregnant or breast-feeding
    • if hypersensitive to diphenhydramine HCl and other similar antihistamines
    • with any other product containing diphenhydramine, even one used on skin
    • to make a child sleepy

    Ask a doctor before use if you have

    • glaucoma
    • a breathing problem such as emphysema or chronic bronchitis
    • a sodium restricted diet
    • trouble urinating due to an enlarged prostate gland

    Ask a doctor or pharmacist before use if

    • taking tranquilizers or sedatives

    When using this product

    • marked drowsiness may occur
    • avoid alcoholic drinks
    • alcohol, sedatives, and tranquilizers may increase drowsiness
    • be careful when driving a motor vehicle or operating machinery
    • excitability may occur, especially in children

    Keep out of reach of children.

    In case of overdose, get medical help or contact a Poison Control Center right away. (1-800-222-1222)

    Directions

    Use the following dosage guidelines when using this product

    Age (yr) Dose (mL)

    adults and children 12 years and over take 10 mL every 4 to 6 hours; not more than 60 mL in 24 hours

    children 6 years to under 12 years ask a doctor

    Other information

    • each 10 mL contains: sodium 30 mg
    • store at 20-25°C (68-77°F)
    • protect from excessive moisture
    • do not use if lid seal is open or damaged
    • sugar free, dye free, alcohol free
    • see bottom of cup for lot number and expiration date

    Inactive ingredients cherry flavor, citric acid, glycerin, monoammonium glycyrrhizinate, poloxamer 407, purified water, sodium benzoate, sodium chloride, sodium citrate, sucralose

    Questions or comments?

    Call 1-800-616-2471

    Re-order

    No. 700901

    MAJOR® PHARMACEUTICALS

    17177 N Laurel Park Dr., Suite 233

    Livonia, MI 48152

    Close
  • Acetaminophen 325 mg / 10.15 mL Major Pharmaceuticals

    Tray Acetaminophen 10.15 mL LidNDC 0904-6739-71

    Acetaminophen

    Oral Solution, USP

    325 mg / 10.15 mL

    Delivers 10.15 mL

    See Insert

    For Institutional Use Only

    MAJOR PHARMACEUTICALS

    Livonia, MI 48152

    Sugar Free - Dye Free - Alcohol Free

    Acetaminophen 325 mg / 10.15 mL
    Major Pharmaceuticals

    Directions

    Do not use more than directed Shake well before use

    Age (yr)

    Dose (mL)

    adults

    take 20.3 mL (650 mg) every 4 to 6 hours

    not to exceed 6 doses in a 24-hour period

    do not use more than 10 days unless directed by a doctor

    under 18 years of age

    ask a doctor

    Acetaminophen 325 mg / 5 mL
    Major Pharmaceuticals

    Do not use

    - with any other drug containing acetaminophen (prescription or nonprescription). If you are not sure whether a drug contains acetaminophen, ask a doctor or pharmacist.

    - if you are allergic to acetaminophen or any other inactive ingredients in this product

    ____________________________________________________________________________

    Ask a doctor before use if the user

    - has liver disease - is pregnant or breast-feeding

    ____________________________________________________________________________

    Ask a doctor or pharmacist before use if you are taking the blood thinning drug warfarin

    ____________________________________________________________________________

    Stop use and ask a doctor if

    - pain gets worse or lasts more than 10 days - new symptoms occur

    - fever gets worse or lasts more than 3 days - redness or swelling is present

    These could be signs of a serious condition

    ____________________________________________________________________________

    Acetaminophen 325 mg / 10.15 mL
    Major Pharmaceuticals

    Inactive ingredients cherry flavor, citric acid, glycerin, methylcellulose, microcrystalline cellulose, propyl paraben, propylene glycol, purified water, sodium benzoate, sorbitol, sucralose, xantham gum

    Acetaminophen 325 mg / 10.15 mL
    Major Pharmaceuticals

    Active ingredient (in each 10.15 mL cup) ­ Purpose Acetaminophen USP 325 mg…………………………..………………..Pain reliever / fever reducer

    Acetaminophen 325 mg / 10.15 mL
    Major Pharmaceuticals

    Uses temporarily relieves minor aches and pains due to:

    • minor pain of arthritis
    • muscular aches
    • backache
    • premenstrual and menstrual cramps
    • the common cold
    • headache
    • toothache
    • temporarily reduces fever

    Acetaminophen 325 mg / 10.15 mL
    Major Pharmaceuticals

    Keep out of reach of children.

    Overdose warning: taking more than the recommended dose (overdose) may cause liver damage. In case of overdose, get medical help or contact Poison Control Center (1-800-222-1222) right away. Quick medical attention is critical for adults as well as for children even if you do not notice any signs or symptoms.

    Acetaminophen 325 mg / 10.15 mL
    Major Pharmaceuticals

    Pain reliever / fever reducer

    Acetaminophen 325 mg / 10.15 mL
    Major Pharmaceuticals

    Other information

    • store at 20°-25°C (68°-77°F). Avoid excessive heat 40°C (104°F)
    • protect from excessive moisture
    • do not use if lid seal is open or damaged
    • sugar free, dye free, alcohol free
    • see bottom of cup for lot number and expiration date

    Acetaminophen 325 mg / 10.15 mL
    Major Pharmaceutcals - IFU

    IFU Acetaminophen 10.15 mL

    Close
  • Acetaminophen 650 mg / 20.3 mL Major Pharmaceuticals

    TrayAcetaminophen 20.3 mL LidNDC 0904-6820-76

    Acetaminophen

    Oral Solution, USP

    650 mg / 20.3 mL

    Delivers 20.3 mL

    See Insert

    For Institutional Use Only

    MAJOR PHARMACEUTICALS

    Livonia, MI 48152

    Sugar Free - Dye Free - Alcohol Free

    Acetaminophen 650 mg / 20.3 mL
    Major Pharmaceuticals

    Directions

    Do not use more than directed Shake well before use

    Age (yr)

    Dose (mL)

    adults

    take 20.3 mL (650 mg) every 4 to 6 hours

    not to exceed 6 doses in a 24-hour period

    do not use more than 10 days unless directed by a doctor

    under 18 years of age

    ask a doctor

    Acetaminophen 650 mg / 20.3 mL
    Major Pharmaceuticals

    Warnings

    Liver warning: This product contains acetaminophen. Severe liver damage may occur if

    • adults take more than 6 doses in 24 hours which is the maximum daily amount
    • taken with other drugs containing acetaminophen
    • adult has 3 or more alcoholic drinks every day while using this product

    Allergy alert: Acetaminophen may cause severe skin reactions. Symptoms may include:

    • skin reddening
    • blisters
    • rash
    • If a skin reaction occurs, stop use and seek medical help right away

    ____________________________________________________________________________

    Do not use

    • with any other drug containing acetaminophen (prescription or nonprescription). If you are not sure whether a drug contains acetaminophen, ask a doctor or pharmacist.
    • if you are allergic to acetaminophen or any other inactive ingredients in this product

    ____________________________________________________________________________

    Ask a doctor before use if the user

    • has liver disease
    • is pregnant or breast-feeding ____________________________________________________________________________

    Ask a doctor or pharmacist before use if you are taking the blood thinning drug warfarin

    ____________________________________________________________________________

    Stop use and ask a doctor if

    • pain gets worse or lasts more than 10 days
    • new symptoms occur
    • fever gets worse or lasts more than 3 days
    • redness or swelling is present

    These could be signs of a serious condition

    Acetaminophen 650 mg / 20.3 mL
    Major Pharmaceuticals

    Inactive ingredients cherry flavor, citric acid, glycerin, methylcellulose, microcrystalline cellulose, propyl paraben, propylene glycol, purified water, sodium benzoate, sorbitol, sucralose, xantham gum

    Acetaminophen 650 mg / 20.3 mL
    Major Pharmaceuticals

    Uses temporarily relieves minor aches and pains due to:

    • minor pain of arthritis
    • muscular aches
    • backache
    • premenstrual and menstrual cramps
    • the common cold
    • headache
    • toothache
    • temporarily reduces fever

    Acetaminophen 650 mg / 20.3 mL
    Major Pharmaceuticals

    Keep out of reach of children.

    Overdose warning: taking more than the recommended dose (overdose) may cause liver damage. In case of overdose, get medical help or contact Poison Control Center (1-800-222-1222) right away. Quick medical attention is critical for adults as well as for children even if you do not notice any signs or symptoms.

    Acetaminophen 650 mg / 20.3 mL
    Major Pharmaceuticals - IFU

    IFU Acetaminophen 20.3 mL

    Acetaminophen 650 mg / 20.3 mL
    Major Pharmaceuticals

    Pain reliever / fever reducer

    Acetaminophen 650 mg / 20.3 mL
    Major Pharmaceuticals

    Active ingredient (in each 20.3 mL cup) ­ Purpose Acetaminophen USP 650 mg…………………………..…….………..Pain reliever / fever reducer

    Acetaminophen 650 mg / 20.3 mL
    Major Pharmaceuticals

    Other information

    • store at 20°-25°C (68°-77°F). Avoid excessive heat 40°C (104°F)
    • protect from excessive moisture
    • do not use if lid seal is open or damaged
    • sugar free, dye free, alcohol free
    • see bottom of cup for lot number and expiration date
    Close
  • Milk of Magnesia Concentrated 10 mL Major Pharmaceutical OTC Monograph

    NDC 0904-6840-72

    Milk of Magnesia Concentrate

    2400 mg/10 mL

    Magnesium Hydroxide 2400 mg.

    Saline Laxative

    Shake Well

    See Insert

    For Instituional Use Only

    MAJOR PHARMACEUTICALS

    Livonia, MI 64152

    Sugar Free - Dye Free - Alcohol Free

    Lid 10 mL Milk of Mag Conc

    Milk of Magnesia Concentrated 2400 mg/ 10 mL


    Directions

    - do not exceed the maximum recommended daily dose in a 24 hour period

    - shake well before use

    - dose may be taken once a day preferably at bedtime, in divided doses, or as directed by a doctor

    - drink a full glass (8 oz) of liquid with each dose

    Age (yr)

    Dose (mL)

    adults and children 12 years and over

    10 mL, not more than 20 mL in 24 hours

    children under 12 years

    ask a doctor

    Milk of Magnesia Concentrated 2400 mg / 10 mL

    Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center right away. (1-800-222-1222)

    Milk of Magnesia concentrated 2400 mg / 10 mL

    Warnings

    Ask a doctor before use if you have

    - kidney disease

    - a magnesium-restricted diet

    - stomach pain, nausea, or vomiting

    - a sudden change in bowel habits that lasts more than 2 weeks

    ___________________________________________________________________

    Ask a doctor or pharmacist before use if you are taking any other drug. Take this product two or more hours before or after other drugs. Laxatives may affect how other drugs work.

    ___________________________________________________________________

    Stop use and ask a doctor if

    - you have rectal bleeding or no bowel movements after using this product. These could be signs of a serious condition.

    - you need to use a laxative for more than 1 week

    ___________________________________________________________________

    If pregnant or breast-feeding, ask a health professional before use.

    Milk of Magnesia concentrated 2400 mg / 10 mL

    Inactive ingredients citric acid, glycerin, microcrystalline cellulose, methyl cellulose, purified water, saccharin sodium, sodium citrate, spearmint oil, xantham gum

    Milk of Magnesia Concentrated 2400 mg / 10 mL

    Uses

    - relieves occasional constipation (irregularity)

    - generally produces bowel movement in ½ to 6 hours

    Milk of Magnesia Concentrated 2400 mL / 10 mL

    Active ingredient (in each 10 mL cup) Magnesium hydroxide USP 2400 mg

    Milk of Magnesia concentrated 2400 mg / 10 mL

    Saline laxative

    Milk of Magnesia Concentrated 2400 mg / 10 mL

    Other information

    - each 10 mL contains: calcium 40 mg, sodium 35 mg, and magnesium 1000 mg

    - store at 20-25°C (68-77°F)

    - protect from excessive moisture

    - do not use if lid seal is open or damaged

    - sugar free, dye free, alcohol free

    - see bottom of cup for lot number and expiration date

    Milk of Magnesia Concentrated 2400 mg / 10 mL

    IFU Milk of Magnesia Conc 10 mL

    Close
  • Milk of Magnesia 2400 mg/30 mL Major Pharmaceutical OTC Monograph

    Lid 30 mL Milk of MagnesiaNDC 0904-6846-73

    Milk of Magnesia USP

    2400 mg/30 mL

    Magnesium Hydroxide 2400 mg.

    Saline Laxative

    Shake Well

    See Insert

    For Instituional Use Only

    MAJOR PHARMACEUTICALS

    Livonia, MI 64152

    Sugar Free - Dye Free - Alcohol Free

    Milk of Magnesia 2400 mg/30 mL

    Directions

    - do not exceed the maximum recommended daily dose in a 24 hour period

    - shake well before use

    - dose may be taken once a day preferably at bedtime, or as directed by a doctor

    - drink a full glass (8 oz) of liquid with each dose

    Age (yr)

    Dose (mL)

    adults and children 12 years and over

    30 mL, not more than 60 mL in 24 hrs.

    children under 12 years

    ask a doctor

    Milk of Magnesia 2400 mg/ 30 mL

    Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center right away. (1-800-222-1222)

    Milk of Magnesia 2400 mg/ 30 mL

    Warnings

    Ask a doctor before use if you have

    - kidney disease

    - a magnesium-restricted diet

    - stomach pain, nausea, or vomiting

    - a sudden change in bowel habits that lasts more than 2 weeks

    Ask a doctor or pharmacist before use if you are taking any other drug. Take this product two or more hours before or after other drugs. Laxatives may affect how other drugs work.

    ___________________________________________________________________

    Stop use and ask a doctor if

    - you have rectal bleeding or no bowel movements after using this product. These could be signs of a serious condition.

    - you need to use a laxative for more than 1 week

    ___________________________________________________________________

    If pregnant or breast-feeding, ask a health professional before use.

    Milk of Magnesia 2400 mg / 30 mL

    Inactive ingredients citric acid, glycerin, microcrystalline cellulose, methyl cellulose, purified water, saccharin sodium, sodium citrate, spearmint oil, xanthan gum

    Milk of Magnesia 2400 mg / 30 mL

    Uses

    - relieves occasional constipation (irregularity)

    - generally produces bowel movement in ½ to 6 hours

    Milk of Magnesia 2400 mg / 30 mL

    Active ingredient (in each 30 mL cup)

    Magnesium hydroxide USP 2400 mg

    Milk of Magnesia 2400 mg / 30 mL

    Saline laxative

    Milk of Magnesia 2400 mg / 30 mL

    Other information

    - each 30 mL contains: calcium 40 mg, sodium 100 mg, and magnesium 1000 mg

    - store at 20-25°C (68-77°F) -

    - protect from excessive moisture

    - do not use if lid seal is open or damaged -

    sugar free, dye free, alcohol free

    - see bottom of cup for lot number and expiration date

    Milk of Magnesia 2400 mg / 30 mL

    IFU Milk of Magnesia 30 mL

    Close
  • INGREDIENTS AND APPEARANCE
    ACETAMINOPHEN ORAL SOLUTION 
    acetaminophen oral solution solution
    Product Information
    Product Type HUMAN OTC DRUG Item Code (Source) NDC:0904-6739
    Route of Administration ORAL
    Active Ingredient/Active Moiety
    Ingredient Name Basis of Strength Strength
    ACETAMINOPHEN (UNII: 362O9ITL9D) (ACETAMINOPHEN - UNII:362O9ITL9D) ACETAMINOPHEN 325 mg  in 10.15 mL
    Inactive Ingredients
    Ingredient Name Strength
    GLYCERIN (UNII: PDC6A3C0OX)  
    SODIUM BENZOATE (UNII: OJ245FE5EU)  
    ANHYDROUS CITRIC ACID (UNII: XF417D3PSL)  
    SORBITOL (UNII: 506T60A25R)  
    CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)  
    METHYLCELLULOSE (15 CPS) (UNII: NPU9M2E6L8)  
    SUCRALOSE (UNII: 96K6UQ3ZD4)  
    XANTHAN GUM (UNII: TTV12P4NEE)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    PROPYLPARABEN (UNII: Z8IX2SC1OH)  
    Product Characteristics
    Color white Score     
    Shape Size
    Flavor CHERRY Imprint Code
    Contains     
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NDC:0904-6739-71 10 in 1 CASE 04/08/2019
    1 10 in 1 TRAY
    1 10.15 mL in 1 CUP, UNIT-DOSE; Type 0: Not a Combination Product
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    OTC monograph not final part343 04/08/2019
    DIPHENHYDRAMINE HYDROCHLORIDE 
    diphenhydramine hydrochloride liquid
    Product Information
    Product Type HUMAN OTC DRUG Item Code (Source) NDC:0904-6740
    Route of Administration ORAL
    Active Ingredient/Active Moiety
    Ingredient Name Basis of Strength Strength
    DIPHENHYDRAMINE HYDROCHLORIDE (UNII: TC2D6JAD40) (DIPHENHYDRAMINE - UNII:8GTS82S83M) DIPHENHYDRAMINE HYDROCHLORIDE 12.5 mg  in 5 mL
    Inactive Ingredients
    Ingredient Name Strength
    ANHYDROUS CITRIC ACID (UNII: XF417D3PSL)  
    AMMONIUM GLYCYRRHIZATE (UNII: 3VRD35U26C)  
    SUCRALOSE (UNII: 96K6UQ3ZD4)  
    SODIUM CHLORIDE (UNII: 451W47IQ8X)  
    TRISODIUM CITRATE DIHYDRATE (UNII: B22547B95K)  
    POLOXAMER 407 (UNII: TUF2IVW3M2)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    SODIUM BENZOATE (UNII: OJ245FE5EU)  
    WATER (UNII: 059QF0KO0R)  
    Product Characteristics
    Color      Score     
    Shape Size
    Flavor CHERRY Imprint Code
    Contains     
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NDC:0904-6740-70 10 in 1 CASE 12/04/2018
    1 10 in 1 TRAY
    1 5 mL in 1 CUP, UNIT-DOSE; Type 0: Not a Combination Product
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    OTC monograph final part341 12/04/2018
    DIPHENHYDRAMINE HYDROCHLORIDE 
    diphenhydramine hydrochloride liquid
    Product Information
    Product Type HUMAN OTC DRUG Item Code (Source) NDC:0904-6741
    Route of Administration ORAL
    Active Ingredient/Active Moiety
    Ingredient Name Basis of Strength Strength
    DIPHENHYDRAMINE HYDROCHLORIDE (UNII: TC2D6JAD40) (DIPHENHYDRAMINE - UNII:8GTS82S83M) DIPHENHYDRAMINE HYDROCHLORIDE 25 mg  in 10 mL
    Inactive Ingredients
    Ingredient Name Strength
    ANHYDROUS CITRIC ACID (UNII: XF417D3PSL)  
    AMMONIUM GLYCYRRHIZATE (UNII: 3VRD35U26C)  
    SUCRALOSE (UNII: 96K6UQ3ZD4)  
    SODIUM CHLORIDE (UNII: 451W47IQ8X)  
    TRISODIUM CITRATE DIHYDRATE (UNII: B22547B95K)  
    POLOXAMER 407 (UNII: TUF2IVW3M2)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    SODIUM BENZOATE (UNII: OJ245FE5EU)  
    WATER (UNII: 059QF0KO0R)  
    Product Characteristics
    Color      Score     
    Shape Size
    Flavor CHERRY Imprint Code
    Contains     
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NDC:0904-6741-72 10 in 1 CASE 12/04/2018
    1 10 in 1 TRAY
    1 10 mL in 1 CUP, UNIT-DOSE; Type 0: Not a Combination Product
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    OTC monograph final part341 12/04/2018
    ACETAMINOPHEN ORAL SOLUTION 
    acetaminophen oral solution solution
    Product Information
    Product Type HUMAN OTC DRUG Item Code (Source) NDC:0904-6738
    Route of Administration ORAL
    Active Ingredient/Active Moiety
    Ingredient Name Basis of Strength Strength
    ACETAMINOPHEN (UNII: 362O9ITL9D) (ACETAMINOPHEN - UNII:362O9ITL9D) ACETAMINOPHEN 160 mg  in 5 mL
    Inactive Ingredients
    Ingredient Name Strength
    GLYCERIN (UNII: PDC6A3C0OX)  
    SODIUM BENZOATE (UNII: OJ245FE5EU)  
    ANHYDROUS CITRIC ACID (UNII: XF417D3PSL)  
    SORBITOL (UNII: 506T60A25R)  
    CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)  
    METHYLCELLULOSE (15 CPS) (UNII: NPU9M2E6L8)  
    SUCRALOSE (UNII: 96K6UQ3ZD4)  
    XANTHAN GUM (UNII: TTV12P4NEE)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    PROPYLPARABEN (UNII: Z8IX2SC1OH)  
    Product Characteristics
    Color white Score     
    Shape Size
    Flavor CHERRY Imprint Code
    Contains     
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NDC:0904-6738-70 10 in 1 CASE 04/08/2019
    1 10 in 1 TRAY
    1 5 mL in 1 CUP, UNIT-DOSE; Type 0: Not a Combination Product
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    OTC monograph not final part343 04/08/2019
    ACETAMINOPHEN ORAL SOLUTION 
    acetaminophen oral solution solution
    Product Information
    Product Type HUMAN OTC DRUG Item Code (Source) NDC:0904-6820
    Route of Administration ORAL
    Active Ingredient/Active Moiety
    Ingredient Name Basis of Strength Strength
    ACETAMINOPHEN (UNII: 362O9ITL9D) (ACETAMINOPHEN - UNII:362O9ITL9D) ACETAMINOPHEN 650 mg  in 20.3 mL
    Inactive Ingredients
    Ingredient Name Strength
    GLYCERIN (UNII: PDC6A3C0OX)  
    SODIUM BENZOATE (UNII: OJ245FE5EU)  
    ANHYDROUS CITRIC ACID (UNII: XF417D3PSL)  
    SORBITOL (UNII: 506T60A25R)  
    CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)  
    METHYLCELLULOSE (15 CPS) (UNII: NPU9M2E6L8)  
    SUCRALOSE (UNII: 96K6UQ3ZD4)  
    XANTHAN GUM (UNII: TTV12P4NEE)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    PROPYLPARABEN (UNII: Z8IX2SC1OH)  
    Product Characteristics
    Color white Score     
    Shape Size
    Flavor CHERRY Imprint Code
    Contains     
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NDC:0904-6820-76 10 in 1 CASE 04/08/2019
    1 10 in 1 TRAY
    1 20.3 mL in 1 CUP, UNIT-DOSE; Type 0: Not a Combination Product
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    OTC monograph not final part343 04/08/2019
    MILK OF MAGNESIA 
    magnesium hydroxide suspension
    Product Information
    Product Type HUMAN OTC DRUG Item Code (Source) NDC:0904-6840
    Route of Administration ORAL
    Active Ingredient/Active Moiety
    Ingredient Name Basis of Strength Strength
    MAGNESIUM HYDROXIDE (UNII: NBZ3QY004S) (HYDROXIDE ION - UNII:9159UV381P, MAGNESIUM CATION - UNII:T6V3LHY838) MAGNESIUM HYDROXIDE 2400 mg  in 10 mL
    Inactive Ingredients
    Ingredient Name Strength
    MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U)  
    XANTHAN GUM (UNII: TTV12P4NEE)  
    ANHYDROUS CITRIC ACID (UNII: XF417D3PSL)  
    METHYLCELLULOSE (15 CPS) (UNII: NPU9M2E6L8)  
    SUCRALOSE (UNII: 96K6UQ3ZD4)  
    TRISODIUM CITRATE DIHYDRATE (UNII: B22547B95K)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    WATER (UNII: 059QF0KO0R)  
    Product Characteristics
    Color white (Suspension) Score     
    Shape Size
    Flavor SPEARMINT Imprint Code
    Contains     
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NDC:0904-6840-72 10 in 1 CASE 06/10/2019
    1 10 in 1 TRAY
    1 10 mL in 1 CUP, UNIT-DOSE; Type 0: Not a Combination Product
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    OTC monograph final part331 06/10/2019
    MILK OF MAGNESIA 
    magnesium hydroxide suspension
    Product Information
    Product Type HUMAN OTC DRUG Item Code (Source) NDC:0904-6846
    Route of Administration ORAL
    Active Ingredient/Active Moiety
    Ingredient Name Basis of Strength Strength
    MAGNESIUM HYDROXIDE (UNII: NBZ3QY004S) (HYDROXIDE ION - UNII:9159UV381P, MAGNESIUM CATION - UNII:T6V3LHY838) MAGNESIUM HYDROXIDE 2400 mg  in 30 mL
    Inactive Ingredients
    Ingredient Name Strength
    MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U)  
    XANTHAN GUM (UNII: TTV12P4NEE)  
    ANHYDROUS CITRIC ACID (UNII: XF417D3PSL)  
    METHYLCELLULOSE (15 CPS) (UNII: NPU9M2E6L8)  
    SUCRALOSE (UNII: 96K6UQ3ZD4)  
    TRISODIUM CITRATE DIHYDRATE (UNII: B22547B95K)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    WATER (UNII: 059QF0KO0R)  
    Product Characteristics
    Color white (Suspension) Score     
    Shape Size
    Flavor SPEARMINT Imprint Code
    Contains     
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NDC:0904-6846-73 10 in 1 CASE 06/10/2019
    1 10 in 1 TRAY
    1 30 mL in 1 CUP, UNIT-DOSE; Type 0: Not a Combination Product
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    OTC monograph final part331 06/10/2019
    Labeler - Major Pharmaceuticals (191427277)
    Registrant - Plastikon Healthcare, LLC (041717941)
    Establishment
    Name Address ID/FEI Business Operations
    Plastikon Healthcare, LLC 041717941 manufacture(0904-6740, 0904-6741, 0904-6738, 0904-6739, 0904-6820, 0904-6840, 0904-6846)
    Close