Label: CHILDRENS NON ASPIRIN- acetaminophen liquid

  • 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 2, 2011

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  • 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

    Sore throat warning: If sore throat is severe, persists for more than 2 days, occurs with or is followed by fever, headache, rash, nausea, or vomiting, consult a doctor promptly.

    Do not use

    • with any other product containing acetaminophen

    Stop use and ask a doctor if

    • new symptoms occur
    • redness or swelling is present
    • pain gets worse or lasts for more than 5 days
    • fever gets worse or lasts for more than 3 days

    Keep out of reach of children.

    Enter section text here

    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)
    • shake well before using
    • find right dose on chart below. If possible use weight to dose; otherwise, use age.
    • if needed, repeat dose every 4 hours
    • do not give more than 5 times in 24 hours
    Weight (lb)
    		Age (yr)
    		Dose (tsp or mL)
    under 24
    		under 2
    		ask a doctor
    24-35
    		2-3
    		1 tsp or 5 mL
    36-47
    		4-5
    		1 1/2 tsp or 7.5 mL
    48-59
    		6-8
    		2 tsp or 10 mL
    60-71
    		9-10
    		2 1/2 tsp or 12.5 mL
    72-95
    		11
    		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.
  • Other information

    • each teaspoon contains: sodium 1 mg
    • do not use if bottle wrap, or foil inner seal imprinted "SEALED for YOUR PROTECTION" is broken or missing
    • store between 20-25°C (68-77°F)
    • see bottom panel for lot number and expiration date
  • Inactive ingredients

    propylparaben, carboxymethylcellulose sodium, citric acid, corn syrup, FD and C red #40, flavors, glycerin, propylene glycol, purified water, sodium benzoate, sorbitol, sucralose, sucrose, xanthan gum

  • Package label

    Children's Non-Aspirinimage of bottle label

  • INGREDIENTS AND APPEARANCE
    CHILDRENS NON ASPIRIN 
    acetaminophen liquid
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:67510-0508
    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
    PROPYLPARABEN (UNII: Z8IX2SC1OH)  
    CARBOXYMETHYLCELLULOSE SODIUM (UNII: K679OBS311)  
    CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)  
    CORN SYRUP (UNII: 9G5L16BK6N)  
    FD&C RED NO. 40 (UNII: WZB9127XOA)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    WATER (UNII: 059QF0KO0R)  
    SODIUM BENZOATE (UNII: OJ245FE5EU)  
    SORBITOL (UNII: 506T60A25R)  
    SUCRALOSE (UNII: 96K6UQ3ZD4)  
    SUCROSE (UNII: C151H8M554)  
    XANTHAN GUM (UNII: TTV12P4NEE)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:67510-0508-4120 mL in 1 BOTTLE
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart34309/02/2011
    Labeler - Kareway Product, Inc. (121840057)
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