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infants fever reducer and pain reliever (Rite Aid Corporation)

Available Formats

Dosage Form Package Information Links
LIQUID 1 BOTTLE in 1 CARTON (11822-0590-1) > 59 mL in 1 BOTTLE Label Information

Complete infants fever reducer and pain reliever Information

  • Active ingredient (in each 5 mL)

    Acetaminophen 160 mg


  • Purpose

    Pain reliever/fever reducer


  • Uses

    temporarily:

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

  • 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.


  • 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. Insert syringe tip into bottle opening.
    • flip bottle upside down. Pull yellow part of syringe to the first dose line and then push product back into bottle.
    • pull yellow part of 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.


  • Other information

    • store at 20-25ºC (68-77ºF)
    • do not use if printed neckband is broken or missing

  • 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?

    1-800-719-9260


  • Package/Label Principal Display Panel

    SEE NEW WARNINGS

    Compare to the active ingredient of Infants’ Tylenol® Oral Suspension

    infants’

    fever reducer & pain reliever

    acetaminophen 160 mg/5 mL

    oral suspension

    DYE-FREE

    non-staining formula

    alcohol free

    aspirin free

    ibuprofen free

    gluten-free

    cherry flavor

    for ages 2-3 years

    use only enclosed syringe

    2 FL OZ (59 mL)

    see side panel for more information

    Rite Aid Infants' Fever Reducer & Pain Reliever image 1
    Rite Aid Infants' Fever Reducer & Pain Reliever image 2

  • INGREDIENTS AND APPEARANCE
    INFANTS FEVER REDUCER AND PAIN RELIEVER 
    acetaminophen suspension
    Product Information
    Product Type HUMAN OTC DRUG Item Code (Source) NDC:11822-0590
    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)  
    CALCIUM SULFATE (UNII: WAT0DDB505)  
    CARRAGEENAN (UNII: 5C69YCD2YJ)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)  
    CARBOXYMETHYLCELLULOSE SODIUM (UNII: K679OBS311)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    PROPYLPARABEN (UNII: Z8IX2SC1OH)  
    WATER (UNII: 059QF0KO0R)  
    SODIUM BENZOATE (UNII: OJ245FE5EU)  
    SORBITOL (UNII: 506T60A25R)  
    SUCRALOSE (UNII: 96K6UQ3ZD4)  
    SODIUM PHOSPHATE, TRIBASIC (UNII: A752Q30A6X)  
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NDC:11822-0590-1 1 in 1 CARTON
    1 59 mL in 1 BOTTLE; 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 09/08/1993
    Labeler - Rite Aid Corporation (014578892)