Label: ACETAMINOPHEN 80 MG FRUIT CHEW- acetaminophen tablet

  • 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 June 26, 2018

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

  • SPL UNCLASSIFIED SECTION

    Drug Facts

  • Active ingredient (in each tablet)

    Acetaminophen USP, 80 mg

  • Purposes

    Pain Reliever/Fever Reducer

  • Uses

    temporarily reduces fever and relieves minor aches and pains caused by

    • headache
    • the common cold
    • flu
    • toothache
    • sore throat
  • Warnings

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

    • more than 5 doses in 24 hours, which is the maximum daily amount
    • with other drugs containing acetaminophen
  • OTHER SAFETY INFORMATION

    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.

  • OTHER SAFETY INFORMATION

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

  • DO NOT USE

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

  • ASK DOCTOR

    Ask a doctor before use if the child has liver disease

  • ASK DOCTOR/PHARMACIST

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

    Drug Facts continued on back of label

  • STOP USE

    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
    • redness or swelling is present
    • any new symptoms appear

    These could be signs of a serious condition

  • KEEP OUT OF REACH OF CHILDREN

    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 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

    • this product does not contain directions or complete warnings for adult use
    • do not take more than directed (see Overdose warning)
    • find correct dose on chart below
    • if possible, use weight to dose, otherwise use age
    • chew tablets before swallowing
    • give dose every 4 hours while symptoms last
    • do not give more than 5 doses in 24 hours

    Weight (pounds)Age (years)Dose (tablets)
    72-9511-124-6

    60-71

    9-104-5
    48-596-84
    36-474-53
    24-352-32
    under 24under 2ask a doctor

  • Other information

    • Phenylketonurics: each tablet contains: phenylalanine 5 mg

  • Other information

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

    aspartame, compressible sugar, D&C red #27 (Al-lake), dextrose, FD&C yellow #6 (Al-lake), flavors, magnesium stearate, microcrystalline cellulose, stearic acid

  • Questions or comments?

    call 516-341-0666 8:30 am - 4:30 pm ET, Monday - Friday

  • SPL UNCLASSIFIED SECTION

    TAMPER EVIDENT: DO NOT USE IF IMPRINTED SAFETY SEAL UNDER CAP IS BROKEN OR MISSING

  • SPL UNCLASSIFIED SECTION

    *Reliable 1 Laboratories LLC is not affiliated with the owner of the trademark Tylenol®.

    Distributed by: Reliable 1 Laboratories LLC, Valley Stream, NY 11580

    www.reliable1labs.com

  • HOW SUPPLIED

    Product: 50090-3162

    NDC: 50090-3162-0 30 TABLET in a BOTTLE, PLASTIC

  • ACETAMINOPHEN

    Label Image
  • INGREDIENTS AND APPEARANCE
    ACETAMINOPHEN 80 MG FRUIT CHEW 
    acetaminophen tablet
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:50090-3162(NDC:69618-012)
    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)  
    FD&C YELLOW NO. 6 (UNII: H77VEI93A8)  
    MAGNESIUM STEARATE (UNII: 70097M6I30)  
    MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U)  
    D&C RED NO. 27 (UNII: 2LRS185U6K)  
    STEARIC ACID (UNII: 4ELV7Z65AP)  
    DEXTROSE, UNSPECIFIED FORM (UNII: IY9XDZ35W2)  
    SUCROSE (UNII: C151H8M554)  
    Product Characteristics
    Colorpink (Light Pink) Score2 pieces
    ShapeROUNDSize10mm
    FlavorImprint Code AP;051
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:50090-3162-030 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product10/10/2017
    Image of Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart34311/01/2015
    Labeler - A-S Medication Solutions (830016429)
    Establishment
    NameAddressID/FEIBusiness Operations
    A-S Medication Solutions830016429RELABEL(50090-3162)