Label: BABIES R US PAIN AND FEVER- acetaminophen liquid

  • NDC Code(s): 51334-161-10, 51334-161-16
  • Packager: Toys"R"Us, Inc.
  • 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 09/12

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

    Fever reducer/pain reliever

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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
    do not give more than directed (see Liver warning)
    shake well before using
    find right dose on chart. If possible, use weight to dose; otherwise use age.
    use only enclosed syringe designed for use with this product. Do not use any other dosing device.
    remove bottle cap and insert syringe tip through opening at top of the bottle
    tip the bottle upside down and draw medicine into the syringe
    fill to dose level
    dispense liquid slowly into child’s mouth, toward inner cheek
    if needed, repeat dose every 4 hours while symptoms last
    do not give more than 5 times in 24 hours
    do not give for more than 5 days unless directed by a doctor
    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

    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 wrap is broken or missing
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  • Inactive ingredients

    anhydrous citric acid, butylparaben, calcium sulfate, carrageenan, FD&C red no. 40, 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?

    1-800-719-9260

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  • Package/Label Principal Display Panel

    Infants’

    Pain & Fever

    Acetaminophen - Suspension Liquid

    Fever Reducer – Pain Reliever

    Aspirin Free

    Ibuprofen Free

    Alcohol Free

    Cherry Flavor

    Use only with enclosed syringe

    See New Dosage & Directions

    Pediatrician Preferred Dosing System

    Compare to the active ingredient of Infants' Tylenol® Suspension Liquid

    160 mg per 5 ml

    Infants' Pain & Fever Carton Image 1

    Infants' Pain & Fever Carton Image 1

    Infants' Pain & Fever Carton Image 2

    Infants' Pain & Fever Carton Image 2

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  • INGREDIENTS AND APPEARANCE
    BABIES R US PAIN AND FEVER 
    acetaminophen liquid
    Product Information
    Product Type HUMAN OTC DRUG LABEL Item Code (Source) NDC:51334-161
    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  
    FD&C RED NO. 40  
    GLYCERIN  
    HIGH FRUCTOSE CORN SYRUP  
    CELLULOSE, MICROCRYSTALLINE  
    CARBOXYMETHYLCELLULOSE SODIUM  
    PROPYLENE GLYCOL  
    WATER  
    SODIUM BENZOATE  
    SORBITOL  
    SODIUM PHOSPHATE, TRIBASIC  
    Product Characteristics
    Color RED Score     
    Shape Size
    Flavor Imprint Code
    Contains     
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NDC:51334-161-10 1 in 1 CARTON
    1 30 mL in 1 BOTTLE
    2 NDC:51334-161-16 1 in 1 CARTON
    2 60 mL in 1 BOTTLE
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    OTC monograph not final part343 11/29/2011
    Labeler - Toys"R"Us, Inc. (006985808)
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