Label: PAIN RELIEVER CHILDREN- acetaminophen tablet, chewable

  • NDC Code(s): 15127-185-01
  • Packager: L&R Distributors, Inc.
  • 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 August 30, 2017

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

  • Active ingredient (in each tablet)

    Acetaminophen 80 mg

  • Purpose

    Pain reliever/fever reducer

  • Uses

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

    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.

    In case of accidental overdose, get medical help or contact a Poison Control Center (1-800-222-1222) right away. Prompt medical attention is critical for adults as well as for children 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
    • find the right dose on chart below. If possible, use weight to dose; otherwise, use age.
    • chew before swallowing; this product will soften in mouth for ease of chewing
    • 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)  Dose (tablets)*
    Under 24Under 2Ask a doctor
    24-352-32
    36-474-53
    48-596-84
    60-719-105
    72-95116

    * or as directed by a doctor

  • Other information

    • phenylketonurics: Contains Phenylalanine 6 mg per tablet
    • store at 25°C (77°F); excursions permitted between 15°-30°C (59°-86°F)
    • avoid high humidity
    • see end flap for expiration date and lot number
  • Inactive ingredients

    corn starch, D&C red #27 aluminum lake, D&C red #30 aluminum lake, ethylcellulose, flavor, magnesium stearate, mannitol, NutraSweet (aspartame), polyethylene, stearic acid

  • Questions or comments?

    1-800-426-9391

  • Principal Display Panel

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    NDC 15127-185-01

    Ibuprofen Free
    Aspirin Free

    Ages 2-6
    Children's
    Pain Reliever
    Acetaminophen 80 mg

    PAIN RELIEVER / FEVER REDUCER

    Compare to the Active Ingredient of Children’s Tylenol® Meltaways®

    30 Chewable Tablets

    Fruit Flavored

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

    This product is not manufactured or distributed by
    McNeil Consumer Healthcare, owner of the registered
    trademark Children’s Tylenol® Meltaways®.
    50844      REV0416A18501

    Distributed by:
    SELECT BRAND® DISTRIBUTORS
    Pine Bluff, AR 71603 USA
    AC (870) 535-3635

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    SATISFACTION
    GUARANTEED

    Select Brand 44-185

    Select Brand 44-185

  • INGREDIENTS AND APPEARANCE
    PAIN RELIEVER  CHILDREN
    acetaminophen tablet, chewable
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:15127-185
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ACETAMINOPHEN (UNII: 362O9ITL9D) (ACETAMINOPHEN - UNII:362O9ITL9D) ACETAMINOPHEN80 mg
    Inactive Ingredients
    Ingredient NameStrength
    STARCH, CORN (UNII: O8232NY3SJ)  
    D&C RED NO. 27 (UNII: 2LRS185U6K)  
    D&C RED NO. 30 (UNII: 2S42T2808B)  
    MAGNESIUM STEARATE (UNII: 70097M6I30)  
    MANNITOL (UNII: 3OWL53L36A)  
    ASPARTAME (UNII: Z0H242BBR1)  
    STEARIC ACID (UNII: 4ELV7Z65AP)  
    ETHYLCELLULOSE, UNSPECIFIED (UNII: 7Z8S9VYZ4B)  
    Product Characteristics
    ColorPINKScoreno score
    ShapeROUNDSize10mm
    FlavorFRUITImprint Code 44;185
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:15127-185-011 in 1 CARTON09/06/200108/29/2020
    130 in 1 BOTTLE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC MONOGRAPH NOT FINALpart34309/06/200108/29/2020
    Labeler - L&R Distributors, Inc. (012578514)
    Establishment
    NameAddressID/FEIBusiness Operations
    LNK International, Inc.038154464PACK(15127-185)
    Establishment
    NameAddressID/FEIBusiness Operations
    LNK International, Inc.832867894MANUFACTURE(15127-185)
    Establishment
    NameAddressID/FEIBusiness Operations
    LNK International, Inc.967626305PACK(15127-185)
    Establishment
    NameAddressID/FEIBusiness Operations
    LNK International, Inc.868734088PACK(15127-185)