Label: PAIN AND FEVER INFANTS- acetaminophen suspension

  • 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 03/14

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

  • Active ingredient (in each 5 mL)

    Acetaminophen 160 mg

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  • Purposes

    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

    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.

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  • Directions

    this product does not contain directions or complete warnings for adult use
    do not give more than directed (see overdose warning)
    shake well before using
    mL = milliliter
    find right dose on chart. If possible, use weight to dose; otherwise, use age.
    push air out of syringe. Firmly push syringe into bottle opening.
    turn bottle upside down. Pull syringe to the first dose line and then push product back into bottle.
    pull syringe until it reaches and stays at the correct dose
    dispense liquid slowly into child’s mouth, toward inner cheek
    repeat dose every 4 hours while symptoms last
    do not give more than 5 times in 24 hours
    replace cap tightly to maintain child resistance

    Dosing Chart

    Weight (lb)

    Age (yr)

    Dose (mL)*

    under 24

    under 2 years

    ask a doctor

    24-35

    2-3 years

    5 mL

    *or as directed by a doctor

    Attention: use only enclosed syringe specifically designed for use with this product. Do not use any other dosing device.

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  • Other Information

    store at 20-25°C (68-77°F)
    do not use if printed bottle neckband is broken or missing
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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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  • Questions or comments?

    1-800-632-6900

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  • Package/Label Principal Display Panel

    Compare to the active ingredient of INFANTS’ TYLENOL® ORAL SUSPENSION

    See side panel

    SEE NEW DOSAGE & DIRECTIONS

    Infants’ Pain & Fever

    Acetaminophen

    Pain Reliever / Fever Reducer

    Suspension Liquid

    See side panel for more information

    Pediatrician Preferred Dosing System

    Use Only with Enclosed Syringe

    Alcohol Free

    Aspirin Free

    Ibuprofen Free

    Grape Flavor

    2 FL OZ (59 mL)

    160 mg per 5 mL

    Infants' Pain & Fever Image 1
    Infants' Pain & Fever Image 2
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  • INGREDIENTS AND APPEARANCE
    PAIN AND FEVER  INFANTS
    acetaminophen suspension
    Product Information
    Product Type HUMAN OTC DRUG LABEL Item Code (Source) NDC:30142-946
    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  
    BUTYLPARABEN  
    CALCIUM SULFATE  
    CARRAGEENAN  
    D&C RED NO. 33  
    FD&C BLUE NO. 1  
    GLYCERIN  
    HIGH FRUCTOSE CORN SYRUP  
    CELLULOSE, MICROCRYSTALLINE  
    CARBOXYMETHYLCELLULOSE SODIUM  
    PROPYLENE GLYCOL  
    WATER  
    SODIUM BENZOATE  
    SORBITOL  
    SODIUM PHOSPHATE, TRIBASIC  
    Product Characteristics
    Color PURPLE Score     
    Shape Size
    Flavor Imprint Code
    Contains     
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NDC:30142-946-16 1 in 1 CARTON
    1 59 mL in 1 BOTTLE
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    OTC monograph not final part343 09/20/2011
    Labeler - Kroger Company (006999528)
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