Label: CHILDRENS PAIN RELIEVER- acetaminophen tablet, chewable

  • 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 January 25, 2018

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

  • Active ingredient  (in each tablet)

    Acetaminophen 80 mg

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  • Purpose

    Pain reliever/fever reducer

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  • Uses

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

    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 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 dosage.

    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: Taking more than the recommended dose (overdose) may cause liver damage. In case of overdose, get medical help or contact a Poison Control Center right away. Quick medical attention is critical even if you do not notice any signs or symptoms.

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  • Directions

    • this product does not contain directions or complete warning for adult use
    • find the right dose on chart. If possible, use weight to dose; otherwise, use age.
    • dissolve in mouth or chew before swallowing
    • if needed, repeat dose every 4 hours while symptoms last
    • do not give more than 5 times in 24 hours
    • do not give for more than 5 days unless directed by a doctor
     Weight (lb)  Age (yr)  Tablets
     Under 24  Under 2  Ask a doctor
     24-35  2-3  2
     36-47  4-5  3
     48-59  6-8  4
     60-71  9-10  5
     72-95  11  6

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  • Other information

    • store at 25ºC (77ºF); excursions permitted 15°-30°C (59°-86°F)
    • see end flap for expiration date and lot number
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  • Inactive ingredients

    citric acid, D&C red #27 aluminum lake, D&C red #30 aluminum lake, dextrose, ethylcellulose, flavors, magnesium stearate, mannitol, polyethylene, povidone, stearic acid, sucralose

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  • Questions or comments?

    1-800-426-9391

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  • Principal Display Panel

    Compare to Children's Tylenol® Meltaways® active ingredient*

    NDC 37808-447-01

    H-E-B®

    CHILDREN'S PAIN RELIEVER
    Pain Reliever/Fever Reducer

    Acetaminophen 80 mg
    Rapid Melts
    • Ages 2-6
    • Ibuprofen & Aspirin Free

    Bubble Gum Flavor

    30 Tablets

    ACTUAL SIZE

    *This product is not manufactured or distributed by McNeil Consumer Healthcare, owner of the registered trademark Children's Tylenol® Meltaways®.

    50844     ORG041244701

    TAMPER EVIDENT: DO NOT USE IF IMPRINTED SAFETY SEAL UNDER CAP IS BROKEN OR MISSING

    HEB 44-447

    HEB 44-447

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  • INGREDIENTS AND APPEARANCE
    CHILDRENS PAIN RELIEVER 
    acetaminophen tablet, chewable
    Product Information
    Product Type HUMAN OTC DRUG Item Code (Source) NDC:37808-447
    Route of Administration ORAL
    Active Ingredient/Active Moiety
    Ingredient Name Basis of Strength Strength
    ACETAMINOPHEN (UNII: 362O9ITL9D) (ACETAMINOPHEN - UNII:362O9ITL9D) ACETAMINOPHEN 80 mg
    Inactive Ingredients
    Ingredient Name Strength
    CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)  
    D&C RED NO. 27 (UNII: 2LRS185U6K)  
    D&C RED NO. 30 (UNII: 2S42T2808B)  
    ETHYLCELLULOSE, UNSPECIFIED (UNII: 7Z8S9VYZ4B)  
    MAGNESIUM STEARATE (UNII: 70097M6I30)  
    MANNITOL (UNII: 3OWL53L36A)  
    POVIDONE (UNII: FZ989GH94E)  
    STEARIC ACID (UNII: 4ELV7Z65AP)  
    SUCRALOSE (UNII: 96K6UQ3ZD4)  
    Product Characteristics
    Color PINK Score no score
    Shape ROUND Size 13mm
    Flavor BUBBLE GUM Imprint Code 44;447
    Contains     
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NDC:37808-447-01 1 in 1 CARTON 02/03/2005 11/28/2020
    1 30 in 1 BOTTLE, PLASTIC; 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 02/03/2005 11/28/2020
    Labeler - H E B (007924756)
    Establishment
    Name Address ID/FEI Business Operations
    LNK International, Inc. 038154464 PACK(37808-447)
    Establishment
    Name Address ID/FEI Business Operations
    LNK International, Inc. 832867894 MANUFACTURE(37808-447)
    Establishment
    Name Address ID/FEI Business Operations
    LNK International, Inc. 832867837 PACK(37808-447)
    Establishment
    Name Address ID/FEI Business Operations
    LNK International, Inc. 868734088 PACK(37808-447)
    Establishment
    Name Address ID/FEI Business Operations
    LNK International, Inc. 967626305 PACK(37808-447)
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