PAIN RELIEF CHILDRENS DYE FREE (ACETAMINOPHEN) SUSPENSION [H E B]

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PAIN RELIEF CHILDRENS DYE FREE (ACETAMINOPHEN) SUSPENSION [H E B]
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NDC 37808-285-04
Set ID 3f9beeeb-5e27-4b81-a647-20e65f0e9fc9
Category HUMAN OTC DRUG LABEL
Packager H E B
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
    • temporarily 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 non-prescription). If you are not sure whether a drug contains acetaminophen, ask a doctor or pharmacist.
    • if your child is allergic to acetaminophen or any of the inactive ingredients in this product

    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

    • new symptoms occur
    • redness or swelling is present
    • pain gets worse or lasts more than 5 days
    • fever gets worse or lasts more than 3 days

    These could be signs of a serious condition.

    Keep out of reach of children.

    Overdose warning: Taking more than the recommended dose (overdose) may cause liver damage. In case of overdose, get medical help or contact a Poison Control Center (1-800-222-1222) right away. 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 take more than directed (see overdose warning)
    • shake well before using
    • mL = milliliter
    • use only the enclosed dosing cup designed for use with this product. Do not use any other dosing device. 
    • if needed, repeat dose every 4 hours while symptoms last 
    • do not give more than 5 times in 24 hours 
    • do not give more than 5 days unless directed by a doctor
    • find the right dose on chart below. If possible, use weight to dose; otherwise, use age.
    Weight (lb)Age (year)Dose (mL)*
     under 24 under 2 ask a doctor
     24-35 2-3 5 mL
     36-47 4-5 7.5 mL
     48-59 6-8 10 mL
     60-71 9-10 12.5 mL
     72-95 11 15 mL

    *or as directed by a doctor

  • Other information

    • each 5 mL contains:sodium 2 mg
    • store between 20-25ºC (68-77ºF)
    • do not refrigerate
    • see bottom panel for lot number and expiration date
  • Inactive ingredients

    anhydrous citric acid, butylparaben, carboxymethylcellulose sodium, flavor, glycerin, high fructose corn syrup, microcrystalline cellulose, propylene glycol, purified water, sodium benzoate, sorbitol, sucralose, xanthan gum

  • Questions or comments?

    Call toll free: 1-877-753-3935 Monday-Friday 9AM-5PM EST 

  • Principal Display Panel

    Compare to Children's Tylenol® Oral Suspension active ingredient**

    Children's Pain Relief

    Acetaminophen 160 mg per 5 mL

    Oral Suspension

    Pain Reliever / Fever Reducer

    For Ages 2 to 11 years

    • Alcohol free
    • Aspirin free
    • Ibuprofen free

    FL OZ (mL)

    GRAPE FLAVOR

    DYE FREE

    **This product is not manufactured or distributed by McNeil Consumer Healthcare, distributor of Children's Tylenol® Oral Suspension

    TAMPER EVIDENT: DO NOT USE IF CARTON IS OPENED OR IF PRINTED SAFETY SEAL AROUND BOTTLE OR UNDER CAP IS BROKEN OR MISSING.

    MADE WITH PRIDE AND CARE FOR

    H-E-B®, SAN ANTONIO, TX 78204

  • Product Label

    Acetaminophen 160 mg

    H-E-B Children's Pain Relief

  • INGREDIENTS AND APPEARANCE
    PAIN RELIEF  CHILDRENS DYE FREE
    acetaminophen suspension
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:37808-285
    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)  
    BUTYLPARABEN (UNII: 3QPI1U3FV8)  
    CARBOXYMETHYLCELLULOSE SODIUM (UNII: K679OBS311)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    HIGH FRUCTOSE CORN SYRUP (UNII: XY6UN3QB6S)  
    CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    WATER (UNII: 059QF0KO0R)  
    SODIUM BENZOATE (UNII: OJ245FE5EU)  
    SORBITOL (UNII: 506T60A25R)  
    SUCRALOSE (UNII: 96K6UQ3ZD4)  
    XANTHAN GUM (UNII: TTV12P4NEE)  
    Product Characteristics
    Color    Score    
    ShapeSize
    FlavorGRAPEImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:37808-285-041 in 1 BOX04/30/2017
    1118 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC MONOGRAPH NOT FINALpart34304/30/2017
    Labeler - H E B (007924756)
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