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

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.

----------

Major Pharmaceuticals
Unit dose OTC Monograph drugs
Diphenhydramine HCl, APAP and Milk of Mag (conc and non-conc)

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

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

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

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

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

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

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

ACETAMINOPHEN ORAL SOLUTION 
acetaminophen oral solution solution
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:0904-6739
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ACETAMINOPHEN (UNII: 362O9ITL9D) (ACETAMINOPHEN - UNII:362O9ITL9D) ACETAMINOPHEN325 mg  in 10.15 mL
Inactive Ingredients
Ingredient NameStrength
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
Colorwhite (white to light pink) Score    
ShapeSize
FlavorCHERRYImprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:0904-6739-7110 in 1 CASE04/08/2019
110 in 1 TRAY
110.15 mL in 1 CUP, UNIT-DOSE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart34304/08/2019
DIPHENHYDRAMINE HYDROCHLORIDE 
diphenhydramine hydrochloride liquid
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:0904-6740
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
DIPHENHYDRAMINE HYDROCHLORIDE (UNII: TC2D6JAD40) (DIPHENHYDRAMINE - UNII:8GTS82S83M) DIPHENHYDRAMINE HYDROCHLORIDE12.5 mg  in 5 mL
Inactive Ingredients
Ingredient NameStrength
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    
ShapeSize
FlavorCHERRYImprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:0904-6740-7010 in 1 CASE12/04/2018
110 in 1 TRAY
15 mL in 1 CUP, UNIT-DOSE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart34112/04/2018
DIPHENHYDRAMINE HYDROCHLORIDE 
diphenhydramine hydrochloride liquid
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:0904-6741
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
DIPHENHYDRAMINE HYDROCHLORIDE (UNII: TC2D6JAD40) (DIPHENHYDRAMINE - UNII:8GTS82S83M) DIPHENHYDRAMINE HYDROCHLORIDE25 mg  in 10 mL
Inactive Ingredients
Ingredient NameStrength
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    
ShapeSize
FlavorCHERRYImprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:0904-6741-7210 in 1 CASE12/04/2018
110 in 1 TRAY
110 mL in 1 CUP, UNIT-DOSE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart34112/04/2018
ACETAMINOPHEN ORAL SOLUTION 
acetaminophen oral solution solution
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:0904-6738
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ACETAMINOPHEN (UNII: 362O9ITL9D) (ACETAMINOPHEN - UNII:362O9ITL9D) ACETAMINOPHEN160 mg  in 5 mL
Inactive Ingredients
Ingredient NameStrength
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
Colorwhite (White to light pink) Score    
ShapeSize
FlavorCHERRYImprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:0904-6738-7010 in 1 CASE04/08/2019
110 in 1 TRAY
15 mL in 1 CUP, UNIT-DOSE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart34304/08/2019
ACETAMINOPHEN ORAL SOLUTION 
acetaminophen oral solution solution
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:0904-6820
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ACETAMINOPHEN (UNII: 362O9ITL9D) (ACETAMINOPHEN - UNII:362O9ITL9D) ACETAMINOPHEN650 mg  in 20.3 mL
Inactive Ingredients
Ingredient NameStrength
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
Colorwhite (white to light pink) Score    
ShapeSize
FlavorCHERRYImprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:0904-6820-7610 in 1 CASE04/08/2019
110 in 1 TRAY
120.3 mL in 1 CUP, UNIT-DOSE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart34304/08/2019
MILK OF MAGNESIA 
magnesium hydroxide suspension
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:0904-6840
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
MAGNESIUM HYDROXIDE (UNII: NBZ3QY004S) (HYDROXIDE ION - UNII:9159UV381P, MAGNESIUM CATION - UNII:T6V3LHY838) MAGNESIUM HYDROXIDE2400 mg  in 10 mL
Inactive Ingredients
Ingredient NameStrength
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
Colorwhite (Suspension) Score    
ShapeSize
FlavorSPEARMINTImprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:0904-6840-7210 in 1 CASE06/10/2019
110 in 1 TRAY
110 mL in 1 CUP, UNIT-DOSE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart33106/10/2019
MILK OF MAGNESIA 
magnesium hydroxide suspension
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:0904-6846
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
MAGNESIUM HYDROXIDE (UNII: NBZ3QY004S) (HYDROXIDE ION - UNII:9159UV381P, MAGNESIUM CATION - UNII:T6V3LHY838) MAGNESIUM HYDROXIDE2400 mg  in 30 mL
Inactive Ingredients
Ingredient NameStrength
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
Colorwhite (Suspension) Score    
ShapeSize
FlavorSPEARMINTImprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:0904-6846-7310 in 1 CASE06/10/2019
110 in 1 TRAY
130 mL in 1 CUP, UNIT-DOSE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart33106/10/2019
Labeler - Major Pharmaceuticals (191427277)
Registrant - Plastikon Healthcare, LLC (041717941)
Establishment
NameAddressID/FEIBusiness Operations
Plastikon Healthcare, LLC041717941manufacture(0904-6740, 0904-6741, 0904-6738, 0904-6739, 0904-6820, 0904-6840, 0904-6846)

Revised: 1/2021
Document Id: b9bb6450-2e7f-8d61-e053-2a95a90a48c0
Set id: 81f30812-60c2-65c0-e053-2991aa0afed6
Version: 8
Effective Time: 20210125
 
Major Pharmaceuticals