Label: CHILDRENS CHEWABLE ACETAMINOPHEN- acetaminophen tablet, chewable

  • NDC Code(s): 51376-130-10
  • Packager: BLESSINGS INTERNATIONAL
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None

Drug Label Information

Updated October 17, 2023

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

View All Sections
  • Active ingredient (in each tablet)

    Acetaminophen 80 mg

  • Purpose

    Pain reliever/fever reducer

  • Uses

    • temporarily relieves minor aches and pains
    • temporarily 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
    • 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 a doctor before use if your child has

    liver disease.

    Ask a doctor or pharmacist before use if your child is

    taking the blood thinning drug warfarin.

    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.

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

  • Directions

    Chew tablets thoroughly before swallowing.
    This product does not contain directions or complete warnings for adults.
    Follow dosage on table or use as doctor directs. If possible
    use weight to dose; otherwise use age. Give every 4 hours
    as needed; do not give more than 5 doses in 24 hours.
    Administer only under adult supervision.
    DO NOT EXCEED DOSE SHOWN. See Overdose Warning.

    Weight (lbs)Under 2424-3536-4748-5960-7172-95
    AgeUnder 22-34-56-89-1011
    TabletsAsk Doctor23456

  • Other information

    • TAMPER EVIDENT: Do not use if imprinted seal under cap is missing or broken.
    • store at 20°C-25°C (68°F-77°F); avoid high humidity
    • Keep tightly closed
    • Phenylketonurics: contains phenylalanine 5mg per tablet.
  • Inactive ingredients

    Aspartame (contains phenylalanine), cellulose, D&C Red #27, Dextrose, FD&C Yellow #6, fruit flavor,
    magnesium stearate, Prosweet, stearic acid, sugar.

  • Principal display panel

    1

  • INGREDIENTS AND APPEARANCE
    CHILDRENS CHEWABLE ACETAMINOPHEN 
    acetaminophen tablet, chewable
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:51376-130
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ACETAMINOPHEN (UNII: 362O9ITL9D) (ACETAMINOPHEN - UNII:362O9ITL9D) ACETAMINOPHEN80 mg
    Inactive Ingredients
    Ingredient NameStrength
    ASPARTAME (UNII: Z0H242BBR1)  
    INVERT SUGAR (UNII: ED959S6ACY)  
    D&C RED NO. 27 (UNII: 2LRS185U6K)  
    DEXTROSE (UNII: IY9XDZ35W2)  
    FD&C YELLOW NO. 6 (UNII: H77VEI93A8)  
    MAGNESIUM STEARATE (UNII: 70097M6I30)  
    MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U)  
    STEARIC ACID (UNII: 4ELV7Z65AP)  
    Product Characteristics
    Colorpink (light) Score2 pieces
    ShapeROUNDSize10mm
    FlavorFRUITImprint Code AP;051
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:51376-130-101000 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product11/01/2022
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph DrugM01311/01/2022
    Labeler - BLESSINGS INTERNATIONAL (064965742)
    Registrant - Geri-Care Pharmaceutical Corp (611196254)
View All Sections

Find additional resources

(also available in the left menu)

Safety

Report Adverse Events, FDA Safety Recalls, Presence in Breast Milk

Related Resources

Medline Plus, Clinical Trials, PubMed, Biochemical Data Summary

More Info on this Drug

View Labeling Archives, RxNorm, Get Label RSS Feed, View NDC Code(s)NEW!