SUNMARK PAIN AND FEVER CHILDRENS (ACETAMINOPHEN) SUSPENSION [MCKESSON]

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SUNMARK PAIN AND FEVER CHILDRENS (ACETAMINOPHEN) SUSPENSION [MCKESSON]
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NDC 49348-325-34
Set ID 590b3b76-c395-431a-944b-3da669024050
Category HUMAN OTC DRUG LABEL
Packager Strategic Sourcing Services LLC
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

    COMPARE TO CHILDREN’S TYLENOL® ORAL SUSPENSION ACTIVE INGREDIENT

    Children’s pain & fever

    Acetaminophen 160 mg per 5 mL

    Pain reliever/Fever reducer

    For ages 2 to 11 years

    Suspension Liquid

    Aspirin Free

    Alcohol Free

    Ibuprofen Free

    Dye Free

    NO HIGH FRUCTOSE CORN SYRUP

    GRAPE FLAVOR

    GLUTEN FREE

    4 FL OZ (118 mL)

    397-s1-pain-&-fever.jpg
  • INGREDIENTS AND APPEARANCE
    SUNMARK PAIN AND FEVER  CHILDRENS
    acetaminophen suspension
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:49348-325
    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
    ColorWHITE (viscous) Score    
    ShapeSize
    FlavorImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:49348-325-341 in 1 CARTON01/17/2013
    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 finalpart34301/17/2013
    Labeler - Strategic Sourcing Services LLC (116956644)
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