Label: HEALTH MART CHILDRENS PAIN AND FEVER- acetaminophen suspension

  • NDC Code(s): 62011-0183-1
  • Packager: Strategic Sourcing Services LLC
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: OTC monograph not final

DISCLAIMER: Most OTC drugs are not reviewed and approved by 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 April 28, 2020

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

  • 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

    SUSPENSION LIQUID

    Children’s Pain & Fever

    Acetaminophen 160 mg per 5 mL

    Pain Reliever/Fever Reducer

    For ages 2 to 11 years

    No high fructose corn syrup

    Aspirin Free

    Alcohol Free

    Ibuprofen Free

    Gluten Free

    Dye Free

    GRAPE FLAVOR

    4 Fl oz (118 mL)

    397-w6-childrens-pain-&-fever.jpg
  • INGREDIENTS AND APPEARANCE
    HEALTH MART CHILDRENS PAIN AND FEVER 
    acetaminophen suspension
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:62011-0183
    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
    FlavorGRAPEImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:62011-0183-11 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)