Label: PAIN RELIEF CHILDRENS- acetaminophen liquid 

  • Label RSS
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: OTC monograph not final

NOTE: Most over the counter (OTC) are not reviewed and approved by the 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 10/12

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

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

    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

    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

    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.

    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

    this product does not contain directions or complete warnings for adult use
    shake well before using
    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 directed (see Liver warning)
    do not give more than 5 times in 24 hours
    do not give for more than 5 days unless directed by a doctor

    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.

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  • Other information

    each teaspoon contains: sodium 3 mg
    store at 20°-25°C (68°-77°F)
    do not use if printed neckband is broken or missing
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  • Inactive ingredients

    anhydrous citric acid, calcium sulfate, carrageenan, flavor, glycerin, hydroxyethyl cellulose, microcrystalline cellulose and carboxymethylcellulose sodium, propylene glycol, propylparaben, purified water, sodium benzoate, sorbitol solution, sucralose, tribasic sodium phosphate

    Questions or comments?

    1-800-632-6900

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  • Package/Label Principal Display Panel

    COMPARE TO active ingredient of CHILDREN’S TYLENOL® ORAL SUSPENSION

    See side panel

    For Ages 2 to 11

    Children’s Pain Relief

    Acetaminophen

    Oral Suspension

    Pain Reliever/Fever Reducer

    Dye-Free

    Non-Staining

    Alcohol Free, Aspirin Free, Ibuprofen Free, Gluten Free

    No High Fructose Corn Syrup

    Dosage Cup Included

    Cherry Flavor

    80 mg per ½ teaspoon

    (160 mg per 5 ml)

    Children's Pain Relief Carton Image 1
    Children's Pain Relief Carton Image 2
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  • INGREDIENTS AND APPEARANCE
    PAIN RELIEF  CHILDRENS
    acetaminophen liquid
    Product Information
    Product Type HUMAN OTC DRUG LABEL Item Code (Source) NDC:30142-959
    Route of Administration ORAL DEA Schedule     
    Active Ingredient/Active Moiety
    Ingredient Name Basis of Strength Strength
    ACETAMINOPHEN (ACETAMINOPHEN) ACETAMINOPHEN 160 mg  in 5 mL
    Inactive Ingredients
    Ingredient Name Strength
    ANHYDROUS CITRIC ACID  
    CALCIUM SULFATE  
    CARRAGEENAN  
    GLYCERIN  
    CELLULOSE, MICROCRYSTALLINE  
    CARBOXYMETHYLCELLULOSE SODIUM  
    PROPYLENE GLYCOL  
    PROPYLPARABEN  
    WATER  
    SODIUM BENZOATE  
    SORBITOL  
    SUCRALOSE  
    SODIUM PHOSPHATE, TRIBASIC  
    Product Characteristics
    Color WHITE (opaque,viscous) Score     
    Shape Size
    Flavor CHERRY Imprint Code
    Contains     
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NDC:30142-959-26 1 in 1 CARTON
    1 118 mL in 1 BOTTLE
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    OTC monograph not final part343 09/20/2012
    Labeler - Kroger Company (006999528)
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