Label: COUNTERACT CHILDRENS PAIN RELIEVER- 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 March 16, 2011

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  • ACTIVE INGREDIENT

    Active ingredient (in each 5 mL teaspoon)
    Acetaminophen 160 mg

  • PURPOSE

    Purpose
    Pain reliever/fever reducer

  • INDICATIONS & USAGE

    Use temporarily:

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

    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, 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 whether a drug contains acetaminophen, ask a doctor or pharmacist.

  • ASK DOCTOR

    Ask a doctor before use if your child has liver disease

  • ASK DOCTOR/PHARMACIST

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

  • 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
    • new symptoms occur
    • redness or swelling is present
    These could be signs of a serious condition.
  • KEEP OUT OF REACH OF CHILDREN

    Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center right away. (1-800-222-1222) Quick medical attention is critical even if you do not notice any signs or symptoms.

  • DOSAGE & ADMINISTRATION

    Directions

    • do not give more than directed (see Liver warning)
    • shake well before use
    • find right dose on chart. 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.
    • if needed, 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
    • this product does not contain directions or complete warnings for adult use
    Weight (lb)
    		Age (yr)
    		Dose (tsp or mL)
    under 24
    		under 2 years
    		ask a doctor
    24-35
    		2-3 years
    		1 tsp or 5 mL
    36-47
    		4-5 years
    		1 1/2 tsp or 7.5 mL
    48-59
    		6-8 years
    		2 tsp or 10 mL
    60-71
    		9-10 years
    		2 1/2 tsp or 12.5 mL
    72-95
    		11 years
    		3 tsp or 15 mL
    Attention: use only enclosed dosing cup specifically designed for use with this product. Do not use any other dosing device/
  • STORAGE AND HANDLING

    Other information

    • store at 20°-25°C (68°-77°F)
  • GENERAL PRECAUTIONS

    • each teaspoon contains: sodium 3 mg
    • do not use if printed neckband is broken or missing
  • INACTIVE INGREDIENT

    Inactive ingredients  anhydrous citric acid, butylparaben, carboxymethylcellulose sodium, carrageenan, FD and C red no. 40, flavor, glycerin, high fructose corn syrup, hydroxyethyl cellusose, microcrystalline cellulose, propylene glycol, purified water, sodium benzoate, sorbitol solution

  • QUESTIONS

    Questions or comments?
    1-800-282-3000

  • PRINCIPAL DISPLAY PANEL

    image of label
  • PRINCIPAL DISPLAY PANEL

    image of box
  • INGREDIENTS AND APPEARANCE
    COUNTERACT  CHILDRENS PAIN RELIEVER
    acetaminophen suspension
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:54473-098
    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
    ANHYDROUS CITRIC ACID (UNII: XF417D3PSL)  
    BUTYLPARABEN (UNII: 3QPI1U3FV8)  
    CARBOXYMETHYLCELLULOSE SODIUM (UNII: K679OBS311)  
    CARRAGEENAN (UNII: 5C69YCD2YJ)  
    CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)  
    FD&C RED NO. 40 (UNII: WZB9127XOA)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    HIGH FRUCTOSE CORN SYRUP (UNII: XY6UN3QB6S)  
    HYDROXYETHYL CELLULOSE (4000 MPA.S FOR 1% AQUEOUS SOLUTION) (UNII: ZYD53NBL45)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    SODIUM BENZOATE (UNII: OJ245FE5EU)  
    SORBITOL (UNII: 506T60A25R)  
    WATER (UNII: 059QF0KO0R)  
    Product Characteristics
    Colorred (Red) Score    
    ShapeSize
    FlavorCHERRY (cherry) Imprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:54473-098-041 in 1 BOX
    15 mL in 1 BOTTLE
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart34301/12/2010
    Labeler - Melaleuca, Inc. (139760102)
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