Label: ACETAMINOPHEN liquid

  • Category: HUMAN OTC DRUG LABEL

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 March 17, 2021

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  • ACTIVE INGREDIENT

    Active ingredient (per 5mL teaspoonful)

    Acetaminophen 160 mg

  • PURPOSE

    Pain Reliever / Fever Reducer

  • Uses

    temporarily • relieves minor aches • reduces fever

  • Warnings

    Liver Warning: This product contains acetaminophen. Severe liver damage may

    occur if your child takes: • more than 5 doses in 24 hours, which is the maximum

    daily amount • taken with other drugs containing acetaminophen

    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 your child is allergic to acetaminophen or any of

    the inactive ingredients in this product

  • ASK DOCTOR

    Ask a doctor before use if your child has a liver disease.

  • ASK DOCTOR/PHARMACIST

    Ask a doctor or pharmacist before use if your child is taking the blood thinning drug warfarin.

  • WHEN USING

    When using this product: Do not exceed recommended dose.

  • Stop use and ask a doctor if

    • pain gets worse or lasts more than 5 days

    • fever gets worse or lasts more than 3 days • new symptoms occur

    • redness or swelling is present. These could be signs of a serious condition.

  • Keep out of reach of children.

    In case of overdose, get medical help or contact a Poison Control Center right away. Quick medical attention is critical even if you do not notice any signs or symptoms.

  • Directions

    • do not take more than directed

    This product does not contain directions or complete warnings for adult use.

    • find dose in chart below, if possible, use weight to dose, otherwise use age

    • dosage may be repeated every 4 hours as needed, or as directed by a doctor

    • do not give more than 5 doses in 24 hours • 5 milliliters (mL) = 1 teaspoon

    Weight (lb)

    Under 24

    24-36

    36-47

    48-59

    60-71

    72-95

    age (yr)

    Under 2

    2-3

    4-5

    6-8

    9-10

    11

    Dosage (mL)

    ask a doctor

    5 mL

    7.5 mL

    10 mL

    12.5 mL

    15 mL

  • Other information

    • each teaspoonful (5 mL) contains: sodium 7.9 mg

    • store at room temperature 15°- 30°C (59°-86°F)

    • protect from freezing • protect from light

    • TAMPER-EVIDENT: Do not use if imprinted seal under cap is broken or missing.

  • Inactive ingredients:

    artificial cherry flavor, citric acid, FD&C Red #40, glycerin, PEG, purified water, saccharin sodium, sodium benzoate, sodium citrate, sorbitol.

  • PRINCIPAL DISPLAY PANEL

    • Compare To Active ingredient of Children's Tylenol

    NDC 72091-004-01

    Children's Liquid

    Pain Reliever and Fever Reducer

    Acetaminophen 160 mg/5mL

    • Asprin Free

    • Alcohol Free

    • For Children Ages 2 - 11 years

    Fruit Flavor

    8 FL OZ (237 mL)

    apap

  • INGREDIENTS AND APPEARANCE
    ACETAMINOPHEN 
    acetaminophen liquid
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:72091-004
    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
    CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)  
    SODIUM BENZOATE (UNII: OJ245FE5EU)  
    SODIUM CITRATE (UNII: 1Q73Q2JULR)  
    SORBITOL (UNII: 506T60A25R)  
    FD&C RED NO. 40 (UNII: WZB9127XOA)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    POLYETHYLENE GLYCOL 400 (UNII: B697894SGQ)  
    WATER (UNII: 059QF0KO0R)  
    SACCHARIN SODIUM (UNII: SB8ZUX40TY)  
    Product Characteristics
    ColorredScore    
    ShapeSize
    FlavorFRUITImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:72091-004-01237 mL in 1 BOTTLE; Type 0: Not a Combination Product03/17/2021
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart34303/17/2021
    Labeler - SAMJAN GROUP INC. (080313200)
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