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 September 25, 2013

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

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  • SPL UNCLASSIFIED SECTION

    Drug Facts

  • Active ingredient (in each 5 mL = 1 teaspoon)

    Acetaminophen 160 mg

  • Purpose

    Pain reliever/fever reducer

  • Uses

    temporarily:

    • reduces fever
    • 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 nonprescription). Ask a doctor or pharmacist before using with other drugs if you are not sure.
    • 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. (1-800-222-1222) Quick medical attention is critical even if you do not notice any signs or symptoms.

  • Directions

    • do not give more than directed (see Liver and overdose warning)
    • shake well before use
    • this product does not contain directions or complete warnings for adult use
    • use only with enclosed dosing cup
    • repeat dose every 4 hours if needed
    • do not give more than 5 times in 24 hours
    • do not give for more than 5 days unless directed by a doctor
    • find right dose on chart below. If possible, use weight to dose, otherwise; use age.
    Weight (lb)Age (yr)Dose (tsp or mL)
    under 24under 2 yearsask a doctor
    24-352-3 years1 tsp or 5 mL
    36-474-5 years1 1/2 tsp or 7.5 mL
    48-596-8 years2 tsp or 10 mL
    60-719-10 years2 1/2 tsp or 12.5 mL
    72-9511 years3 tsp or 15 mL
  • Other information

    • each teaspoon contains: sodium 3 mg
    • store at 20°-25°C (68°-77°F)
  • Inactive ingredients

    anhydrous citric acid, butylparaben, carboxymethylcellulose sodium, carrageenan, D&C red no. 33, FD&C blue no. 1, flavor, glycerin, high fructose corn syrup, hydroxyethyl cellulose, microcrystalline cellulose, propylene glycol, purified water, sodium benzoate, sorbitol solution

  • Questions?

    Call 601-859-0038

  • SPL UNCLASSIFIED SECTION

    Distributed by: R3 Pharmaceuticals,LLC
    Canton, MS 39046

  • PRINCIPAL DISPLAY PANEL - 118 mL Bottle Carton

    NDC 59999-001-04

    SEE NEW WARNINGS INFORMATION

    *Compare to the active ingredient in
    Children's Tylenol® Oral Suspension*

    Children's
    Acetaminophen
    oral suspension

    80 mg per 1/2 teaspoon
    (160 mg per 5 mL)

    fever reducer/
    pain reliever

    AGE
    2-11
    YEARS

    Grape Flavor

    R3 Pharmaceuticals

    4 FL OZ (118 mL)

    Principal Display Panel - 118 mL Bottle Carton
  • INGREDIENTS AND APPEARANCE
    CHILDRENS ACETAMINOPHEN 
    acetaminophen suspension
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:59999-001
    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)  
    D&C RED NO. 33 (UNII: 9DBA0SBB0L)  
    FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    HIGH FRUCTOSE CORN SYRUP (UNII: XY6UN3QB6S)  
    HYDROXYETHYL CELLULOSE (100 MPA.S AT 2%) (UNII: R33S7TK2EP)  
    CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    WATER (UNII: 059QF0KO0R)  
    SODIUM BENZOATE (UNII: OJ245FE5EU)  
    SORBITOL (UNII: 506T60A25R)  
    Product Characteristics
    ColorPURPLEScore    
    ShapeSize
    FlavorGRAPEImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:59999-001-041 in 1 CARTON
    1118 mL in 1 BOTTLE, PLASTIC
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC MONOGRAPH NOT FINALpart34309/23/2013
    Labeler - R3 Pharmaceuticals, LLC (078888843)
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