Label: NON-ASPIRIN CHILDRENS- acetaminophen tablet, chewable

  • NDC Code(s): 63868-186-24
  • Packager: CHAIN DRUG MARKETING ASSOCIATION 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 15, 2017

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

  • Active ingredient (in each tablet)

    Acetaminophen 160 mg

    Close
  • Purpose

    Pain reliever/fever reducer

    Close
  • Uses

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

    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.

    Close
  • 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 24 Under 2 Ask a doctor
    24-35
    2-3 1
    36-47 4-5 1 1/2
    48-59 6-8 2
    60-71 9-10 2 1/2
    72-95 11 3

    *or as directed by a doctor

    Close
  • Other information

    • store at 25ºC (77ºF); excursions permitted between 15º-30ºC (59º-86ºF)
    • avoid high humidity
    • see end flap for expiration date and lot number
    Close
  • Inactive ingredients

    citric acid, crospovidone, D&C red #27 aluminum lake, D&C red #30 aluminum lake, dextrates hydrated, ethylcellulose, FD&C blue #1 aluminum lake, flavors, magnesium stearate, mannitol, polyethylene, stearic acid, sucralose

    Close
  • Questions or comments?

    1-800-426-9391

    Close
  • Principal display panel

    QC®
    QUALITY
    CHOICE

    NDC 63868-186-24

    Compare to the active ingredient in Children's Tylenol®

    children's
    NON-ASPIRIN

    Acetaminophen, 160 mg
    Pain Reliever / Fever Reducer

    Ages 2-11

    Ibuprofen Free ι Aspirin Free

    Pain / Fever

    GRAPE FLAVORED

    24 CHEWABLE TABLETS 

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

    DISTRIBUTED BY: C.D.M.A., Inc. ©
    43157 W 9 Mile Rd
    Novi, MI 48375
    www.qualitychoice.com
    Questions: 248-449-9300

    SATISFACTION GUARANTEE
    100% QC

    **This product is not manufactured or distributed
    by Johnson & Johnson Corporation, owner of the
    registered trademark Children's Tylenol®.

    50844     ORG101644908

    Quality Choice 44-449

    Quality Choice 44-449

    Close
  • INGREDIENTS AND APPEARANCE
    NON-ASPIRIN  CHILDRENS
    acetaminophen tablet, chewable
    Product Information
    Product Type HUMAN OTC DRUG Item Code (Source) NDC:63868-186
    Route of Administration ORAL
    Active Ingredient/Active Moiety
    Ingredient Name Basis of Strength Strength
    ACETAMINOPHEN (UNII: 362O9ITL9D) (ACETAMINOPHEN - UNII:362O9ITL9D) ACETAMINOPHEN 160 mg
    Inactive Ingredients
    Ingredient Name Strength
    CROSPOVIDONE (UNII: 2S7830E561)  
    D&C RED NO. 27 ALUMINUM LAKE (UNII: ZK64F7XSTX)  
    FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
    MAGNESIUM STEARATE (UNII: 70097M6I30)  
    MANNITOL (UNII: 3OWL53L36A)  
    STEARIC ACID (UNII: 4ELV7Z65AP)  
    SUCRALOSE (UNII: 96K6UQ3ZD4)  
    CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)  
    D&C RED NO. 30 (UNII: 2S42T2808B)  
    DEXTROSE MONOHYDRATE (UNII: LX22YL083G)  
    ETHYLCELLULOSE, UNSPECIFIED (UNII: 7Z8S9VYZ4B)  
    Product Characteristics
    Color PURPLE Score 2 pieces
    Shape ROUND Size 16mm
    Flavor GRAPE Imprint Code 44;449
    Contains     
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NDC:63868-186-24 1 in 1 CARTON 01/28/2005
    1 24 in 1 BOTTLE; 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 01/28/2005
    Labeler - CHAIN DRUG MARKETING ASSOCIATION INC (011920774)
    Establishment
    Name Address ID/FEI Business Operations
    LNK International, Inc. 832867894 MANUFACTURE(63868-186)
    Establishment
    Name Address ID/FEI Business Operations
    LNK International, Inc. 832867837 PACK(63868-186)
    Establishment
    Name Address ID/FEI Business Operations
    LNK International, Inc. 868734088 PACK(63868-186)
    Establishment
    Name Address ID/FEI Business Operations
    LNK International, Inc. 967626305 PACK(63868-186)
    Establishment
    Name Address ID/FEI Business Operations
    LNK International, Inc. 038154464 PACK(63868-186)
    Close