Label: CHILDRENS PAIN RELIEF- acetaminophen tablet, chewable

  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: OTC monograph not final

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 September 26, 2017

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

  • Active ingredient (in each tablet)

    Acetaminophen 80 mg

  • Purpose

    Pain reliever/fever reducer

  • Uses

    • temporarily reduces fever 
    • temporarily relieves minor aches and pains due to:
      • the common cold
      • headache
      • flu
      • sore throat
      • toothache
  • 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

    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.

    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.

    When using this product

    do not exceed recommended dosage.

    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: Taking more than the recommended dose (overdose) may cause liver damage. In case of overdose, get medical help or contact a Poison Control Center (1-800-222-1222) right away. Quick medical attention is critical even if you do not notice any signs or symptoms.

  • Directions

    • do not give more than directed (see overdose warning)
    • this product does not contain directions or complete warnings for adult use
    • find the right dose on chart below. If possible, use weight to dose; otherwise, use age.
    • chew before swallowing; this product will soften in mouth for ease of chewing
    • repeat dose every 4 hours while symptoms last
    • do not give more than 5 times in 24 hours
    • do not give for more than 5 days unless directed by a doctor
     Weight (lb)Age (yr) Dose (tablets)*
     Under 24Under 2Ask a doctor
    24-352-32
    36-474-53
    48-596-84
    60-719-105
    72-95116

    *or as directed by a doctor

  • Other information

    • store at 25ºC (77ºF); excursions permitted between 15°-30°C (59°-86°F)
    • avoid high humidity
    • protect from light
    • see end flap for expiration date and lot number
  • Inactive ingredients

    citric acid, crospovidone, D&C red #27 aluminum lake, D&C red #30 aluminum lake, dextrates, ethylcellulose, FD&C blue #1 aluminum lake, flavors, magnesium stearate, mannitol, polyethylene, stearic acid, sucralose

  • Questions or comments?

    1-800-426-9391

  • Principal Display Panel

    ♥CVS Health

    Compare to the active ingredient
    in Children's Tylenol® Meltaways®†

    Rapid Tabs

    NDC 59779-452-01 

    Children's
    Pain Relief
    ACETAMINOPHEN,
    80 mg

    Pain reliever, Fever reducer
    Ages 2-6

    • Aspirin free
    • Ibuprofen free

    30 TABLETS

    Grape Flavor
    Actual Product Size on Side Panel

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

    This product is not manufactured or distributed by McNeil
    Consumer Healthcare, owner of the registered trademark
    Children's Tylenol® Meltaways®.
    50844      ORG101345201

    Distributed by:
    CVS Pharmacy, Inc.
    One CVS Drive, Woonsocket, RI 02895
    © 2015 CVS/pharmacy    CVS.com® 
    1-800-SHOP CVS   V-11112

    CVS 44-452

    CVS 44-452

  • INGREDIENTS AND APPEARANCE
    CHILDRENS PAIN RELIEF 
    acetaminophen tablet, chewable
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:59779-452
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ACETAMINOPHEN (UNII: 362O9ITL9D) (ACETAMINOPHEN - UNII:362O9ITL9D) ACETAMINOPHEN80 mg
    Inactive Ingredients
    Ingredient NameStrength
    CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)  
    D&C RED NO. 27 (UNII: 2LRS185U6K)  
    D&C RED NO. 30 (UNII: 2S42T2808B)  
    ETHYLCELLULOSE, UNSPECIFIED (UNII: 7Z8S9VYZ4B)  
    FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
    MAGNESIUM STEARATE (UNII: 70097M6I30)  
    MANNITOL (UNII: 3OWL53L36A)  
    STEARIC ACID (UNII: 4ELV7Z65AP)  
    SUCRALOSE (UNII: 96K6UQ3ZD4)  
    CROSPOVIDONE, UNSPECIFIED (UNII: 2S7830E561)  
    DEXTRATES (UNII: G263MI44RU)  
    Product Characteristics
    ColorPURPLEScoreno score
    ShapeROUNDSize13mm
    FlavorGRAPEImprint Code 44;452
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:59779-452-011 in 1 CARTON12/06/200404/03/2020
    130 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC MONOGRAPH NOT FINALpart34312/06/200404/03/2020
    Labeler - CVS Pharmacy (062312574)
    Establishment
    NameAddressID/FEIBusiness Operations
    LNK International, Inc.832867894MANUFACTURE(59779-452)
    Establishment
    NameAddressID/FEIBusiness Operations
    LNK International, Inc.038154464PACK(59779-452)
    Establishment
    NameAddressID/FEIBusiness Operations
    LNK International, Inc.832867837PACK(59779-452)
    Establishment
    NameAddressID/FEIBusiness Operations
    LNK International, Inc.967626305PACK(59779-452)
    Establishment
    NameAddressID/FEIBusiness Operations
    LNK International, Inc.868734088PACK(59779-452)