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 October 20, 2017

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

  • SPL UNCLASSIFIED SECTION

    Grape Flavor

    80 mg/2.5 mL  160 mg/5 mL  325 mg/10.15 mL

    For Hospital Use Only

    Drug Facts

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  • Active ingredient (in each 5 mL)

    Acetaminophen 160 mg

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  • Purpose

    Pain reliever/fever reducer

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  • Uses

    temporarily:

    • reduces fever
    • relieves 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

    Allergy alert

    Acetaminophen may cause severe skin reactions. Symptoms may include:

    • skin reddening
    • blisters
    • rash

    If a skin reaction occurs, stop use and seek medical help right away.

    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). If you are not sure whether a drug contains acetaminophen, ask a doctor or pharmacist.
    • if your child has ever had an allergic reaction to this product or any of its ingredients

    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

    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.

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  • Directions

    • use as directed per healthcare professional
    • this product does not contain directions or complete warnings for adult use
    • do not give more than directed (see overdose warning)
    • shake cups well before using
    • mL = milliliter
    • 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
    Weight (lb) Age (yr) Dose (mL)*
    *
    or as directed by a doctor
    under 24 under 2 years ask a doctor
    24-35 2-3 years 5 mL
    36-47 4-5 years 7.5 mL
    48-59 6-8 years 10 mL
    60-71 9-10 years 12.5 mL
    72-95 11 years 15 mL
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  • Other information

    • each 5 mL contains: sodium 3 mg
    • store at 20-25°C (68-77°F)
    • see individual label or shipper for lot number and expiration date
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  • Inactive ingredients

    anhydrous citric acid, butylparaben, calcium sulfate, carrageenan, D&C red #33, FD&C blue #1, flavor, glycerin, high fructose corn syrup, hydroxyethyl cellulose, microcrystalline cellulose and carboxymethylcellulose sodium, propylene glycol, purified water, sodium benzoate, sorbitol solution, tribasic sodium phosphate

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  • SPL UNCLASSIFIED SECTION

    Alcohol Free, Aspirin Free, Gluten Free, Ibuprofen Free

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  • How Supplied

    NDC 68094-586-58
    2.5 mL per unit dose syringe
    Fifty (50) syringes per shipper

    NDC 68094-587-58
    5 mL per unit dose syringe
    Fifty (50) syringes per shipper

    NDC 68094-587-61
    5 mL per unit dose cup
    One hundred (100) cups per shipper

    NDC 68094-587-62
    5 mL per unit dose cup
    Thirty (30) cups per shipper

    NDC 68094-588-62
    10.15 mL per unit dose cup
    Thirty (30) cups per shipper

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  • SPL UNCLASSIFIED SECTION

    Distributed By
    Perrigo Company
    Allegan, MI 49010

    Packaged By
    Precision Dose, Inc.
    South Beloit, IL 61080

    LI950   Rev. 03/17

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  • PRINCIPAL DISPLAY PANEL - 5 mL Cup Label

    NDC 68094-587-59

    PrecisionDose ™

    Children's ACETAMINOPHEN
    Oral Suspension
    160 mg/5 mL

    Pkg: Precision Dose, Inc., S. Beloit, IL 61080

    Principal Display Panel - 5 mL Cup Label
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  • INGREDIENTS AND APPEARANCE
    CHILDRENS ACETAMINOPHEN 
    acetaminophen suspension
    Product Information
    Product Type HUMAN OTC DRUG Item Code (Source) NDC:68094-587(NDC:0113-0212)
    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
    anhydrous citric acid (UNII: XF417D3PSL)  
    butylparaben (UNII: 3QPI1U3FV8)  
    calcium sulfate, unspecified form (UNII: WAT0DDB505)  
    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)  
    microcrystalline cellulose (UNII: OP1R32D61U)  
    carboxymethylcellulose sodium, unspecified form (UNII: K679OBS311)  
    propylene glycol (UNII: 6DC9Q167V3)  
    water (UNII: 059QF0KO0R)  
    sodium benzoate (UNII: OJ245FE5EU)  
    sorbitol (UNII: 506T60A25R)  
    sodium phosphate, tribasic (UNII: A752Q30A6X)  
    Product Characteristics
    Color PURPLE Score     
    Shape Size
    Flavor GRAPE Imprint Code
    Contains     
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NDC:68094-587-58 5 in 1 CASE 04/11/2014
    1 10 in 1 BAG
    1 5 mL in 1 SYRINGE, PLASTIC; Type 0: Not a Combination Product
    2 NDC:68094-587-62 3 in 1 CASE 04/11/2014
    2 10 in 1 TRAY
    2 NDC:68094-587-59 5 mL in 1 CUP, UNIT-DOSE; Type 0: Not a Combination Product
    3 NDC:68094-587-61 10 in 1 CASE 04/11/2014
    3 10 in 1 TRAY
    3 NDC:68094-587-59 5 mL in 1 CUP, UNIT-DOSE; Type 0: Not a Combination Product
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    OTC MONOGRAPH NOT FINAL part343 04/11/2014
    Labeler - Precision Dose Inc. (035886746)
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