Label: CHILDRENS ACETAMINOPHEN ORAL SUSPENSION GRAPE FLAVOR- acetaminophen suspension

  • NDC Code(s): 70005-040-01
  • Packager: We Care Distributor Inc.
  • 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 26, 2016

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

  • Active ingredient

    (in each 5 mL)
    Acetaminophen 160 mg

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  • Purpose

    Acetaminophen
    160 mg.............................Pain reliever/fever reducer

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  • Uses

    temporarily

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

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  • 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 product

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  • Ask a doctor before use if your child has

    liver disease.

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  • Ask a doctor or pharmacist before use if your child

    is taking the blood thinning drug warfarin.

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  • When using this product

    do not exceed recommended dose (see overdose warning)

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  • 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.

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  • Keep out of reach of children.

    Enter section text here

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  • 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. Quick medical attention is critical for adults as well as for children even if you do not notice any signs or symptoms.

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  • Directions

    • this product does not contain directions or complete warnings for adult use.
    • shake well before using
    • mL = mililiter
    • find right dose on chart below. If possible, use weight to dose; otherwise, use age.
    • 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 (yr)        Dose (tsp or 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

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  • Other information

    • each teaspoon (5mL) contains: sodium 3 mg
    • store between 15-30˚C (59-86˚F)
    • protect from freezing
    • protect from light
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  • Inactive ingredients

    butyl paraben, carboxymethylcellulose sodium, cellulose, citric acid, D&C red # 33, FD&C blue # 1, flavors, glycerin, high fructose corn syrup, propylene glycol, purified water, sodium benzoate, sorbitol, sucralose, xanthan gum

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  • QUESTIONS OR COMMENTS?

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

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  • Principal Display Panel

    Childrens Acetaminophen Oral Suspension

    • Fever reducer
    • Pain reliever

    Alcohol Free
    Aspirin Free
    Ibuprofen Free

    Grape Flavor

    Compare to active ingredient in Childrens Tylenol Fever reducer Pain reliever

    2 FL OZ (60 mL)

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  • INGREDIENTS AND APPEARANCE
    CHILDRENS ACETAMINOPHEN ORAL SUSPENSION  GRAPE FLAVOR
    acetaminophen suspension
    Product Information
    Product Type HUMAN OTC DRUG Item Code (Source) NDC:70005-040
    Route of Administration ORAL
    Active Ingredient/Active Moiety
    Ingredient Name Basis of Strength Strength
    Acetaminophen (UNII: 362O9ITL9D) (Acetaminophen - UNII:362O9ITL9D) Acetaminophen 160 mg  in 5 mL
    Inactive Ingredients
    Ingredient Name Strength
    SODIUM BENZOATE (UNII: OJ245FE5EU)  
    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)  
    SORBITOL (UNII: 506T60A25R)  
    SUCRALOSE (UNII: 96K6UQ3ZD4)  
    XANTHAN GUM (UNII: TTV12P4NEE)  
    D&C RED NO. 33 (UNII: 9DBA0SBB0L)  
    FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
    Product Characteristics
    Color      Score     
    Shape Size
    Flavor GRAPE (grape flavor) Imprint Code
    Contains     
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NDC:70005-040-01 60 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product 09/26/2016
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    OTC monograph not final part343 09/26/2016
    Labeler - We Care Distributor Inc. (079832998)
    Establishment
    Name Address ID/FEI Business Operations
    PURINE PHARMA LLC 019950491 manufacture(70005-040)
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