GOOD SENSE PAIN AND FEVER (ACETAMINOPHEN) SUSPENSION [L. PERRIGO COMPANY]

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GOOD SENSE PAIN AND FEVER (ACETAMINOPHEN) SUSPENSION [L. PERRIGO COMPANY]
PDF | XML
NDC 0113-0397-26
Set ID a74f246d-94e6-45d2-8d6b-1aaf0833d5ff
Category HUMAN OTC DRUG LABEL
Packager L. Perrigo Company
Generic Name
Product Class
Product Number
Application Number PART343
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  • 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 below. If possible, use weight to dose; otherwise, use age.
    •
    remove the child protective cap and squeeze your child’s dose into the dosing cup
    •
    repeat dose every 4 hours while symptoms last
    •
    do not give more than 5 times in 24 hours

    Weight (lb)

    Age (yr)

    Dose (mL)*

    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

    *or as directed by a doctor

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

  • Other information

    •
    each 5 mL contains: sodium 3 mg
    •
    store at 20-25°C (68-77°F)
    •
    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

    Ages 2 - 11 Years

    Children’s Pain & Fever

    Pain Reliever/Fever Reducer

    Acetaminophen 160 mg per 5 mL

    Oral Suspension

    Fast, effective relief of children’s pain and fever

    Dye Free

    Alcohol Free

    Aspirin Free

    Ibuprofen Free

    Grape Flavor

    Compare to active ingredient of Children’s Tylenol® Oral Suspension

    100% SATISFACTION GUARANTEED

    4 FL OZ (118 mL)

    childrens pain and fever image
  • INGREDIENTS AND APPEARANCE
    GOOD SENSE PAIN AND FEVER 
    acetaminophen suspension
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:0113-0397
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ACETAMINOPHEN (UNII: 362O9ITL9D) (ACETAMINOPHEN - UNII:362O9ITL9D) ACETAMINOPHEN160 mg  in 5 mL
    Inactive Ingredients
    Ingredient NameStrength
    ANHYDROUS CITRIC ACID (UNII: XF417D3PSL)  
    CALCIUM SULFATE, UNSPECIFIED FORM (UNII: WAT0DDB505)  
    CARRAGEENAN (UNII: 5C69YCD2YJ)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U)  
    CARBOXYMETHYLCELLULOSE SODIUM, UNSPECIFIED FORM (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)  
    Product Characteristics
    ColorWHITEScore    
    ShapeSize
    FlavorGRAPEImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:0113-0397-261 in 1 CARTON03/22/2012
    1118 mL in 1 BOTTLE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart34303/22/2012
    Labeler - L. Perrigo Company (006013346)
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