Label: CHILDRENS ACETAMINOPHEN- acetaminophen suspension

  • 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 17, 2016

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

  • Active Ingredient (in each 5 mL)

    Acetaminophen 160 mg

  • Purpose

    Acetaminophen.............................Pain reliever/fever reducer

  • Uses

    • temporarily reduces fever
    • temporarily relieves minor aches and pains due to:
    • the common cold 
    • flu 
    • headache 
    • 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 non-prescription). 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 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

    • new symptoms occur
    • redness or swelling is present
    • pain gets worse or lasts more than 5 days
    • fever gets worse or lasts more than 3 days
    These could be signs of a serious condition.

  • Keep out of the reach of children.

    Overdose Warning: Taking more than the recommended dose (overdose) may cause liver damage. In case of accidental overdose, seek
    professional assistance or contact a Poison Control Center immediately. 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.
    • shake well before using

    • mL = milliliter
    • find right dose on chart below. If possible, use weight to dose; otherwise, use age.
    • use only enclosed dosing cup designed for use with this product. Do not use any other dosing device.
    • repeat dose every 4 hours while symptoms last
    • do not give more than 5 times in 24 hours
    • do not give more than 5 days unless directed by a doctor

    Weight (lb.)                     Age (yrs.)                     Dose (mL*)
    under 24                          under 2                      ask a doctor
    24-35                                 2-3                             5 mL
    36-47                                 4-5                             7.5 mL
    48-59                                 6-8                             10 mL
    60-71                                 9-10                           12.5 mL
    72-95                                 11                              15 mL

    * always check with your doctor before administering medicine to your infant/child

  • Other information

    • each teaspoon (mL) contains: Sodium 3 mg
    • store between 150-300C (590-860F)
    • Protect from freezing
    • Protect from light
  • Inactive Ingredients

    butylparaben, carboxymethylcellulose sodium, cellulose, citric acid, corn syrup, FD&C red #40, flavor, glycerin, microcrystalline cellulose, propylene glycol, purified water, sodium benzoate, sodium saccharin, sorbitol, sucralose, xanthan gum

  • Questions or Comments?

    1-888-705-WECARE (Mon-Fri 9am-5pm EST) or www.wecaredistributor.com

  • Principal Display Panel

    Compare to the active ingredient in Children's Tylenol®*
    Children's Pain Relief
    Suspension Liquid
    Cherry Flavor
    For ages 2 to 11
    2 FL OZ (60 mL)

    image of label

  • INGREDIENTS AND APPEARANCE
    CHILDRENS ACETAMINOPHEN 
    acetaminophen suspension
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:70005-041
    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
    BUTYLPARABEN (UNII: 3QPI1U3FV8)  
    CARBOXYMETHYLCELLULOSE SODIUM (UNII: K679OBS311)  
    CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)  
    CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    HIGH FRUCTOSE CORN SYRUP (UNII: XY6UN3QB6S)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    WATER (UNII: 059QF0KO0R)  
    FD&C Red No. 40 (UNII: WZB9127XOA)  
    SODIUM BENZOATE (UNII: OJ245FE5EU)  
    SACCHARIN SODIUM (UNII: SB8ZUX40TY)  
    SUCRALOSE (UNII: 96K6UQ3ZD4)  
    SORBITOL (UNII: 506T60A25R)  
    XANTHAN GUM (UNII: TTV12P4NEE)  
    Product Characteristics
    Color    Score    
    ShapeSize
    FlavorCHERRY (Cherry Flavor) Imprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:70005-041-011 in 1 CARTON08/17/2016
    160 mL 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 finalpart34308/17/2016
    Labeler - We Care Distributors Inc. (079832998)
    Establishment
    NameAddressID/FEIBusiness Operations
    PURINE PHARMA LLC019950491manufacture(70005-041)