Label: MEDS ON THE GO- acetaminophen, calcium carbonate, dextromethorphan hbr, guaifenesin, phenylephrine hcl, ibuprofen, loperamide hcl kit

  • Category: HUMAN OTC DRUG LABEL

DISCLAIMER: This drug has not been found by FDA to be safe and effective, and this labeling has not been approved by FDA. For further information about unapproved drugs, click here.

Drug Label Information

Updated January 1, 2019

If you are a healthcare professional or from the pharmaceutical industry please visit this version.

  • EXTRA STRENGTH NON-ASPIRIN

    Active ingredient (in each tablet)

    Acetaminophen 500 mg

  • EXTRA STRENGTH NON-ASPIRIN

    Purpose

    Pain reliever/fever reducer

  • EXTRA STRENGTH NON-ASPIRIN

    Uses

    For the temporary relief of minor aches and pains associated with

    • headache
    • muscular aches
    • minor arthritis pain
    • common cold
    • toothache
    • menstrual cramps

    For the reduction of fever.

  • EXTRA STRENGTH NON-ASPIRIN

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

    • more than 8 tablets in 24 hours, which is the maximum daily amount
    • with other drugs containing acetaminophen
    • 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.

  • EXTRA STRENGTH NON-ASPIRIN

    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.
    • for more than 10 days for pain unless directed by a doctor
    • for more than 3 days for fever unless directed by a doctor

  • EXTRA STRENGTH NON-ASPIRIN

    Ask a doctor before use if you have liver disease

  • EXTRA STRENGTH NON-ASPIRIN

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

  • EXTRA STRENGTH NON-ASPIRIN

    Stop using and ask a doctor if

    • symptoms do not improve
    • new symptoms occur
    • pain or fever persists or gets worse
    • redness or swelling is present
  • EXTRA STRENGTH NON-ASPIRIN

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

  • EXTRA STRENGTH NON-ASPIRIN

    Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center right away. Prompt medical attention is critical for adults as well as for children even if you do not notice any signs or symptoms.

  • EXTRA STRENGH NON-ASPIRIN

    Directions

    • ​do not use more than directed

    Adults and children:

    (12 years and older)

    Take 2 tablets with water every 4 to 6 hours as needed.

    Do not take more than 8 tablets in 24 hours.

    Children under 12 years:

    Do not give this adult strength product to children under

    12 years of age; this will provide more than the recommended

    dose (overdose) and may cause liver damage.

  • EXTRA STRENGTH NON-ASPIRIN

    Other information

    • store at room temperature 59° - 86°F (15° - 30°C)
    • tamper evident sealed packets
    • do not use any opened or torn packets

  • EXTRA STRENGTH NON-ASPIRIN

    Inactive ingredients

    corn starch, hypromellose, maltodextrin*, microcrystalline cellulose*, polyethylene glycol, povidone*, pregelatinized starch*, sodium starch glycolate*, stearic acid, titanium dioxide*.
    * may contain

  • EXTRA STRENGTH NON-ASPIRIN

    Questions? 1-800-634-7680

  • ANTACID

    Active ingredient (in each tablet)

    Calcium Carbonate 420 mg

  • ANTACID

    Purpose

    Antacid

  • ANTACID

    Uses

    For the relief of the following symptoms associated with

    • acid indigestion
    • sour stomach
    • heartburn
    • upset stomach
  • ANTACID

    Warnings

  • ANTACID

    Ask a doctor or health professional before use if you have

    • been taking a prescription drug. Antacids may interact with certain prescription drugs
    • kidney stones
    • a calcium-restricted diet

  • ANTACID

    Stop using this product and ask a doctor if symptoms last more than 2 weeks

  • ANTACID

    Do not exceed recommended dosage.

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

  • ANTACID

    Keep out of the reach of children.

  • ANTACID

    Directions

    • do not use more than directed
    • Adults and children (12 years and older): Chew 2 tablets every 2 or 3 hours as symptoms occur or as directed by a physician. Do not take more than 19 tablets in a 24 hour period, or use the maximum dosage of this product for more than 2 weeks, except under the advice and supervision of a physician.
    • Children under 12 years: Do not give to children under 12 years of age.
  • ANTACID

    Other information

    • Phenylketonurics: contains phenylalanine 1.5 mg per tablet
    • each tablet contains 168 mg of elemental calcium
    • store at room temperature 59° - 86°F (15° - 30°C)
    • tamper-evident sealed packets
    • do not use any opened or torn packets


  • ANTACID

    Inactive ingredients

    aspartame*, croscarmellose sodium*, gum acacia*, magnesium stearate, maltodextrin, mineral oil*, mint flavor, sorbitol*, sucrose*.
    * may contain

  • ANTACID

    Questions or comments? call 1-800-634-7680

  • COLD RELIEF

    Active ingredient (in each tablet)

    Acetaminophen 325 mg

    Dextromethorphan Hydrobromide 15 mg

    Guaifenesin 200 mg

    Phenylephrine Hydrochloride 5 mg

  • COLD RELIEF

    Purpose

    Pain reliever/fever reducer

    Cough suppressant

    Expectorant

    Nasal decongestant

  • COLD RELIEF

    Uses

    Temporarily relieves these cold symptoms

    • cough
    • sore throat
    • minor aches and pains
    • headache
    • nasal congestion
    • helps loosen phlegm (mucus) and thin bronchial secretions to make coughs more productive

    Temporarily reduces fever.

  • COLD RELIEF

    Warnings

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

    • more than 4,000 mg of acetaminophen in 24 hours
    • with other drugs containing acetaminophen
    • 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.

    Sore throat warning: If sore throat is severe, persists for more than 2 days, is accompanied or followed by fever, headache, rash, nausea or vomiting, consult a doctor promptly.

  • COLD RELIEF

    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 have ever had an allergic reaction to this product or any of its ingredients
    • if you are now taking a prescription monoamine oxidase inhibitor (MAOI) (certain drugs for depression, psychiatric or emotional conditions, or Parkinson’s disease), or for 2 weeks after stopping the MAOI drug. If you do not know if your prescription drug contains an MAOI, ask a doctor or pharmacist before taking this product.

  • COLD RELIEF

    • liver disease
    • heart disease
    • high blood pressure
    • thyroid disease
    • diabetes
    • trouble urinating due to an enlarged prostate gland
    • cough that occurs with too much phlegm (mucus)
    • persistent or chronic cough that lasts as occurs with smoking, asthma, chronic bronchitis or emphysema
  • COLD RELIEF

    Ask a doctor or pharmacist before use if you are

    • taking the blood thinning drug warfarin

  • COLD RELIEF

    When using this product

    • do not use more than directed
  • COLD RELIEF

    Stop use and ask a doctor if

    • new symptoms occur
    • redness or swelling is present
    • pain or nasal congestion gets worse or lasts for more than 7 days
    • fever gets worse or lasts for more than 3 days
    • you get nervous, dizzy or sleepless
    • cough comes back or occurs with rash or headache that lasts.

    These could be signs of a serious condition.

  • COLD RELIEF

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

  • COLD RELIEF

    Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center right away. Prompt medical attention is critical for adults as well as for children even if you do not notice any signs or symptoms.

  • COLD RELIEF

    Directions

    Adults and children:

    (12 years and older)

    Take 2 tablets with water every 6-8 hours as needed. Do

    not take more than 8 tablets in 24 hours.

    Children under 12

    years:

    Do not give to children under 12 years of age.

  • COLD RELIEF

    Other information

    • store at room temperature 59° - 86°F (15° - 30°C)
    • avoid excessive heat and humidity
    • tamper evident sealed packets
    • do not use any opened or torn packets

  • COLD RELIEF

    Inactive ingredients maltodextrin, microcrystalline cellulose, povidone, sodium starch glycolate, starch, stearic acid

  • COLD RELIEF

    Questions?

    1-800-634-7680

  • IBUPROFEN

    Active ingredient (in each tablet)

    Ibuprofen 200 mg (NSAID)*

    *non-steroidal anti-inflammatory drug

  • IBUPROFEN

    Purpose

    Pain reliever/fever reducer

  • IBUPROFEN

    Uses

    Temporarily relieves minor aches and pains associated with

    • headache
    • toothache
    • backache
    • menstrual cramps
    • common cold
    • muscular aches
    • minor arthritis pain

    Temporarily reduces fever.

  • IBUPROFEN

    Warnings

    Allergy alert: Ibuprofen may cause a severe allergic reaction, especially in people allergic to aspirin. Symptoms may include:

    • hives
    • skin reddening
    • asthma (wheezing)
    • facial swelling
    • rash
    • shock
    • blisters

    If an allergic reaction occurs, stop use and seek medical help right away.

    Stomach bleeding warning: This product contains an NSAID, which may cause severe stomach bleeding. The chance is higher if you:

    • are age 60 or older
    • have had stomach ulcers or bleeding problems
    • taking a blood thinning (anticoagulant) or steroid drug
    • take other drugs containing prescription or nonprescription NSAIDs (aspirin, ibuprofen, naproxen, or others)
    • have 3 or more alcoholic drinks every day while using this product
    • take more or for a longer time than directed

  • IBUPROFEN

    Do not use

    • if you have ever had an allergic reaction to any other pain reliever/fever reducer
    • right before or after heart surgery

  • IBUPROFEN

    Ask a doctor before use if

    • stomach bleeding warning applies to you
    • you have a history of stomach problems such as heartburn
    • you have high blood pressure, heart disease, liver cirrhosis, or kidney disease
    • you are taking a diuretic
    • you have problems or serious side effects from taking pain relievers or fever reducers
    • you have asthma

  • IBUPROFEN

    Ask a doctor or pharmacist before use if you are

    • taking aspirin for heart attack or stroke, because ibuprofen may decrease this benefit of aspirin
    • taking any other drug
    • under a doctor’s care for any serious condition

  • IBUPROFEN

    When using this product

    • the risk of heart attack or stroke may increase if you use more than directed or longer than directed
    • take with food or milk if stomach upset occurs
  • IBUPROFEN

    Stop use and ask a doctor if

    • you experience any of the following signs of stomach bleeding

    ▪ feel faint ▪ vomit blood ▪ have bloody or black stools
    ▪ have stomach pain that does not get better

    • pain gets worse or lasts for more than 10 days
    • fever gets worse or lasts for more than 3 days
    • redness or swelling is present in the painful area
    • any new or unexpected symptoms occur

  • IBUPROFEN

    If pregnant or breast-feeding, ask a health professional before use. It is especially important not to use ibuprofen during the last 3 months of pregnancy unless specifically directed to do so by a doctor because it may cause problems in the unborn child or complications during delivery.

  • IBUPROFEN

    Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center right away.

  • IBUPROFEN

    Directions

    • do not use more than directed
    • the smallest effective dose should be used
    • do not take longer than 10 days, unless directed by a doctor (see Warnings)

    Adults and children:

    (12 years and older)

    Take 1 tablet every 4 to 6 hours while symptoms persist. If pain for fever

    does not respond to 1 tablet, 2 tablets may be used. Do not exceed 6 tablets

    in 24 hours, unless directed by a doctor.

    Children under 12 years:Do not give to children under 12 years of age.

  • IBUPROFEN

    Other information

    • read all product information before using
    • store at 68° - 77°F (20° - 25°C)
    • avoid excessive heat 104°F (above 40°C)
    • tamper evident sealed packets
    • do not use any opened or torn packet

  • IBUPROFEN

    Inactive ingredients

    carnauba wax*, corn starch, hypromellose*, iron oxide red, lactose*, magnesium stearate*, microcrystalline cellulose*, polydextrose*, polyethylene glycol, polyvinyl alcohol*, povidone (K-30)*, silicon dioxide, sodium starch glycolate, stearic acid, talc*, titanium dioxide

    * may contain

  • IBUPROFEN

    Questions or comments?1-800-634-7680

  • DIAMODE

    Active ingredient (in each caplet)

    Loperamide Hydrochloride 2 mg

  • DIAMODE

    Purpose

    Antidiarrheal

  • DIAMODE

    Uses

    Controls the symptoms of diarrhea, including Traveler's diarrhea

  • DIAMODE

    Warnings

    Allergy alert: Do not use if you have ever had a rash or other allergic reaction to Loperamide HCl

  • DIAMODE

    Do not use if you have bloody or black stool

  • DIAMODE

    Ask a doctor before use if you have

    • a fever
    • mucus in stool
    • a history of liver disease
  • DIAMODE

    Ask a doctor or pharmacist before use if you are taking antibiotics

  • DIAMODE

    When using this product

    • tiredness, drowsiness or dizziness may occur
    • be careful when driving or operating machinery
  • DIAMODE

    Stop use and ask a doctor if

    • symptoms get worse
    • diarrhea lasts more than 2 days
    • upi get abdominal swelling or bulging. These may be signs of a serious condition.
  • DIAMODE

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

  • DIAMODE

    Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center right away.

  • DIAMODE

    Directions

    • do not use more than directed
    • drink plenty of clear fluids to help prevent dehydration caused by diarrhea

    Adults and children:

    (12 years and older)

    Take 2 caplets after the first loose stool

    followed by 1 caplet after each subsequent

    loose stool but no more than 4 caplets in 24 hours.

    Children under 12 years:Do not give to children under 12 years of age.

  • DIAMODE

    Other information

    • store at room temperature 68° - 77°F (20° - 25°C)
    • tamper-evident sealed packets
    • do not use any opened or torn packet
  • DIAMODE

    Inactive ingredients anhydrous lactose, croscarmellose sodium, crospovidone, D&C Yellow #10, FD&C Blue #1, hydrogenated vegetable oil, magnesium stearate, powdered cellulose, pregelatinized starch

  • DIAMODE

    Questions or comments? 1-800-634-7680

  • EXTRA STRENGTH NON-ASPIRIN

    EXTRA STRENGTH

    NON-ASPIRIN

    2 Tablets

    Mfd. for MEDIQUE PRODUCTS • Fort Myers, FL 33967

    APAP image

  • ANTACID

    ANTACID

    2 Tablets

    Mfd for MEDIQUE PRODUCTS, Fort Myers, FL 33967

    Antacid

  • COLD RELIEF

    COLD RELIEF

    2 Tablets

    Mfd for MEDIQUE PRODUCTS, Fort Myers, FL 33967

    Cold Relief

  • IBUPROFEN

    IBUPROFEN

    2 Tablets

    Mfd. for: MEDIQUE PRODUCTS Fort Myers, FL 33967

    Ibuprofen

  • DIAMODE

    Medique

    Diamode

    1 Caplet

    Mfd. for MEDIQUE PRODUCTS, Fort Myers, FL 33967

    Diamode

  • OUTER CARTON PDP

    MEDS ON THE GO...

    INSTANT RELIEF ON THE GO!

    5 Different OTC Medications

    17 Individual Packets

    HEADACHE, TOOTHACHE, MUSCLE ACHES, DIARRHEA, UPSET STOMACH, INDIGESTION, COUGH/COLD...AND MORE!

    Acetaminophen • Ibuprofen • Anti-Diarrheal • Antacid • Decongestant

    MEDSGO-PDP

  • INGREDIENTS AND APPEARANCE
    MEDS ON THE GO 
    acetaminophen, calcium carbonate, dextromethorphan hbr, guaifenesin, phenylephrine hcl, ibuprofen, loperamide hcl kit
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:72082-002
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:72082-002-051 in 1 BOX; Type 1: Convenience Kit of Co-Package01/01/2019
    Quantity of Parts
    Part #Package QuantityTotal Product Quantity
    Part 12 PACKET 3   in 2 
    Part 22 PACKET 4   in 2 
    Part 32 PACKET 3   in 2 
    Part 42 PACKET 3   in 2 
    Part 54 PACKET
    Part 1 of 5
    MEDI-FIRST NON-ASPIRIN EXTRA STRENGTH 
    acetaminophen tablet, film coated
    Product Information
    Item Code (Source)NDC:47682-126
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ACETAMINOPHEN (UNII: 362O9ITL9D) (ACETAMINOPHEN - UNII:362O9ITL9D) ACETAMINOPHEN500 mg
    Inactive Ingredients
    Ingredient NameStrength
    SODIUM STARCH GLYCOLATE TYPE A POTATO (UNII: 5856J3G2A2)  
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
    HYPROMELLOSES (UNII: 3NXW29V3WO)  
    MALTODEXTRIN (UNII: 7CVR7L4A2D)  
    CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)  
    STARCH, CORN (UNII: O8232NY3SJ)  
    POVIDONE (UNII: FZ989GH94E)  
    STEARIC ACID (UNII: 4ELV7Z65AP)  
    POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A)  
    Product Characteristics
    Colorwhite (white) Scoreno score
    ShapeROUND (Round) Size12mm
    FlavorImprint Code FR;33
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:47682-126-992 in 1 PACKET; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart34301/01/2019
    Part 2 of 5
    MEDI-FIRST ANTACID 
    calcium carbonate tablet, chewable
    Product Information
    Item Code (Source)NDC:47682-820
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    CALCIUM CARBONATE (UNII: H0G9379FGK) (CALCIUM CATION - UNII:2M83C4R6ZB, CARBONATE ION - UNII:7UJQ5OPE7D) CALCIUM CARBONATE420 mg
    Inactive Ingredients
    Ingredient NameStrength
    MALTODEXTRIN (UNII: 7CVR7L4A2D)  
    SUCROSE (UNII: C151H8M554)  
    ASPARTAME (UNII: Z0H242BBR1)  
    CROSCARMELLOSE SODIUM (UNII: M28OL1HH48)  
    ACACIA (UNII: 5C5403N26O)  
    MAGNESIUM STEARATE (UNII: 70097M6I30)  
    MINERAL OIL (UNII: T5L8T28FGP)  
    SORBITOL (UNII: 506T60A25R)  
    Product Characteristics
    ColorwhiteScoreno score
    ShapeROUNDSize11mm
    FlavorImprint Code AZ;036
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:47682-820-992 in 1 PACKET; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart33101/01/2019
    Part 3 of 5
    MEDI-FIRST COLD RELIEF 
    acetaminophen, dextromethorphan hydrobromide, guaifenesin, phenylephrine hydrochloride tablet
    Product Information
    Item Code (Source)NDC:47682-139
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ACETAMINOPHEN (UNII: 362O9ITL9D) (ACETAMINOPHEN - UNII:362O9ITL9D) ACETAMINOPHEN325 mg
    PHENYLEPHRINE HYDROCHLORIDE (UNII: 04JA59TNSJ) (PHENYLEPHRINE - UNII:1WS297W6MV) PHENYLEPHRINE HYDROCHLORIDE5 mg
    DEXTROMETHORPHAN HYDROBROMIDE (UNII: 9D2RTI9KYH) (DEXTROMETHORPHAN - UNII:7355X3ROTS) DEXTROMETHORPHAN HYDROBROMIDE15 mg
    GUAIFENESIN (UNII: 495W7451VQ) (GUAIFENESIN - UNII:495W7451VQ) GUAIFENESIN200 mg
    Inactive Ingredients
    Ingredient NameStrength
    MALTODEXTRIN (UNII: 7CVR7L4A2D)  
    CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)  
    POVIDONE (UNII: FZ989GH94E)  
    SODIUM STARCH GLYCOLATE TYPE A CORN (UNII: AG9B65PV6B)  
    STARCH, CORN (UNII: O8232NY3SJ)  
    STEARIC ACID (UNII: 4ELV7Z65AP)  
    Product Characteristics
    Colorwhite (white) Scoreno score
    ShapeROUND (round) Size12mm
    FlavorImprint Code FR;12
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:47682-139-992 in 1 PACKET; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart34101/01/2019
    Part 4 of 5
    MEDI-FIRST IBUPROFEN 
    ibuprofen tablet, coated
    Product Information
    Item Code (Source)NDC:47682-708
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    IBUPROFEN (UNII: WK2XYI10QM) (IBUPROFEN - UNII:WK2XYI10QM) IBUPROFEN200 mg
    Inactive Ingredients
    Ingredient NameStrength
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
    POVIDONE K30 (UNII: U725QWY32X)  
    SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
    CARNAUBA WAX (UNII: R12CBM0EIZ)  
    STARCH, CORN (UNII: O8232NY3SJ)  
    HYPROMELLOSE, UNSPECIFIED (UNII: 3NXW29V3WO)  
    FERRIC OXIDE RED (UNII: 1K09F3G675)  
    LACTOSE MONOHYDRATE (UNII: EWQ57Q8I5X)  
    MAGNESIUM STEARATE (UNII: 70097M6I30)  
    CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)  
    POLYDEXTROSE (UNII: VH2XOU12IE)  
    POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A)  
    POLYVINYL ALCOHOL, UNSPECIFIED (UNII: 532B59J990)  
    SODIUM STARCH GLYCOLATE TYPE A POTATO (UNII: 5856J3G2A2)  
    STEARIC ACID (UNII: 4ELV7Z65AP)  
    TALC (UNII: 7SEV7J4R1U)  
    Product Characteristics
    Colorred (Reddish Brown) Scoreno score
    ShapeROUNDSize10mm
    FlavorImprint Code G;2
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:47682-708-992 in 1 PACKET; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    ANDAANDA07917401/01/2019
    Part 5 of 5
    MEDIQUE DIAMODE 
    loperamide hydrochloride tablet
    Product Information
    Item Code (Source)NDC:47682-200
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    LOPERAMIDE HYDROCHLORIDE (UNII: 77TI35393C) (LOPERAMIDE - UNII:6X9OC3H4II) LOPERAMIDE HYDROCHLORIDE2 mg
    Inactive Ingredients
    Ingredient NameStrength
    STARCH, CORN (UNII: O8232NY3SJ)  
    D&C YELLOW NO. 10 (UNII: 35SW5USQ3G)  
    FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
    MAGNESIUM STEARATE (UNII: 70097M6I30)  
    ANHYDROUS LACTOSE (UNII: 3SY5LH9PMK)  
    CROSPOVIDONE (UNII: 2S7830E561)  
    CORN OIL (UNII: 8470G57WFM)  
    POWDERED CELLULOSE (UNII: SMD1X3XO9M)  
    CROSCARMELLOSE SODIUM (UNII: M28OL1HH48)  
    Product Characteristics
    ColorgreenScore2 pieces
    ShapeOVALSize10mm
    FlavorImprint Code 123
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:47682-200-461 in 1 PACKET; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    ANDAANDA07409101/01/2019
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    unapproved drug other01/01/2019
    Labeler - Doc in the Box LLC (081033259)
    Establishment
    NameAddressID/FEIBusiness Operations
    Doc in the Box LLC081033259repack(72082-002)