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 August 24, 2020

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

View All Sections
  • Active ingredient (in each tablet)

    Acetaminophen 160 mg

  • Purpose

    Pain reliever/fever reducer

  • Uses

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

    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 dose (see overdose warning)

    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 right away at 1-800-222-1222. Quick medical attention is critical 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 give more than directed (see overdose warning)
    ▪
    find the right dose on chart below. If possible, use weight to dose; otherwise use age.
    ▪
    chew before swallowing
    ▪
    if needed, repeat dose every 4 hours while symptoms last
    ▪
    do not give more than 5 times in 24 hours

    Weight (lbs)

    under 24

    24-35

    36-47

    48-59

    60-71

    72-95

    Age (yrs)

    under 2 years

    2-3- years

     4-5 years

    6-8 years

    9-10 years

    11 years

    Dose(tablets)*

     ask a doctor

     1

    1 1/2

    2

    2 1/2

    3
     
    *or as directed by a doctor
  • Other information

    ▪
    store at room temperature Avoid high humidity.
    ▪
    see end flap for expiration date and lot number
    ▪
    keep this carton for future reference on full labeling
  • Inactive ingredients

    citric acid, crospovidone, dextrose, flavor, magnesium stearate, maltodextrin, starch, sucralose

    Questions or comments?

    1-866-467-2748

  • Principal Display Panel

    NDC 69842-160-24

    Compare to the active ingredient in Children’s Tylenol® Chewables†

    Children’s

    Pain Relief

    Acetaminophen 160 mg

    Pain reliever/Fever reducer

    Ages 2-11

    Free of: Aspirin & Ibuprofen

    BUBBLEGUM FLAVOR

    24 CHEWABLE TABLETS

    160 mg each

    TAMPER EVIDENT: DO NOT USE IF PACKAGE IS OPENED OR IF BLISTER UNIT IS TORN, BROKEN OR SHOWS ANY SIGNS OF TAMPERING

    †This product is not manufactured or distributed by McNeil Consumer Healthcare, owner of the registered trademark Children’s Tylenol® Chewables.

    Distributed by: CVS Pharmacy, Inc,

    One CVS Drive, Woonsocket, RI 02895

    ©2017 CVS/Pharmacy

    CVS.com 1-800-SHOP CVS

    CVS Health Children's Pain Relief Acetaminophen 160mg 24 Chewable Tablets
  • INGREDIENTS AND APPEARANCE
    CHILDRENS PAIN RELIEF 
    acetaminophen tablet, chewable
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:69842-160
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ACETAMINOPHEN (UNII: 362O9ITL9D) (ACETAMINOPHEN - UNII:362O9ITL9D) ACETAMINOPHEN160 mg
    Inactive Ingredients
    Ingredient NameStrength
    CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)  
    CROSPOVIDONE (15 MPA.S AT 5%) (UNII: 68401960MK)  
    DEXTROSE, UNSPECIFIED FORM (UNII: IY9XDZ35W2)  
    MAGNESIUM STEARATE (UNII: 70097M6I30)  
    MALTODEXTRIN (UNII: 7CVR7L4A2D)  
    STARCH, CORN (UNII: O8232NY3SJ)  
    SUCRALOSE (UNII: 96K6UQ3ZD4)  
    Product Characteristics
    ColorWHITEScore2 pieces
    ShapeROUNDSize16mm
    FlavorBUBBLE GUMImprint Code RP160
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:69842-160-244 in 1 CARTON11/01/2017
    16 in 1 BLISTER PACK; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart34311/01/2017
    Labeler - CVS Pharmacy,Inc. (062312574)
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!