Label: NON-ASPIRIN JUNIOR STRENGTH- acetaminophen tablet, chewable

  • NDC Code(s): 63868-158-24
  • 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 February 8, 2019

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

  • Active ingredient (in each tablet)

    Acetaminophen 160 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
      • sore throat
      • flu
      • headache
    • 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 (1-800-222-1222) 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 warnings for adult use
    • find the right dose on chart below. 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 48 Under 6 Ask a doctor
    48-59 6-8 2
    60-71 9-10 2 1/2
    72-95 11 3
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  • Other information

    • TAMPER EVIDENT: DO NOT USE IF OUTER PACKAGE IS OPENED OR BLISTER IS TORN OR BROKEN
    • store at 25°C (77°F); excursions permitted between 15°-30°C (59°-86°F)
    • see end flap for expiration date and lot number
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  • 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

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  • Questions or comments?

    Call 248-449-9300

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  • Product Packaging

    QC®
    QUALITY
    CHOICE

    NDC 63868-158-24

    *Compare to the
    active ingredient in
    Junior Strength
    Tylenol® Meltaways®

    AGES 6-11
    NON-ASPIRIN
    Junior Strength
    Acetaminophen,
    160 mg
    Pain Reliever / Fever Reducer

    Ibuprofen Free | Aspirin Free

    Grape Flavored Rapid Melts

    24 TABLETS (160 mg each)

    Actual Size

    TAMPER EVIDENT: DO NOT USE IF PACKAGE IS OPENED OR IF BLISTER UNIT IS TORN, BROKEN OR SHOWS ANY SIGNS OF TAMPERING

    *This product is not manufactured or distributed by McNeil Consumer Healthcare, owner of the registered trademark Junior Strength Tylenol® Meltaways®.
    50844         REV0213C44908

    ©DISTRIBUTED BY C.D.M.A., Inc.
    43157 W. Nine Mile
    Novi, MI 48376-0995
    www.qualitychoice.com
    Questions: 248-449-9300
    Quality Choice 44-449

    Quality Choice 44-449


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  • INGREDIENTS AND APPEARANCE
    NON-ASPIRIN  JUNIOR STRENGTH
    acetaminophen tablet, chewable
    Product Information
    Product Type HUMAN OTC DRUG Item Code (Source) NDC:63868-158
    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
    CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)  
    D&C RED NO. 27 ALUMINUM LAKE (UNII: ZK64F7XSTX)  
    D&C RED NO. 30 (UNII: 2S42T2808B)  
    ETHYLCELLULOSE, UNSPECIFIED (UNII: 7Z8S9VYZ4B)  
    FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
    MAGNESIUM STEARATE (UNII: 70097M6I30)  
    MANNITOL (UNII: 3OWL53L36A)  
    STEARIC ACID (UNII: 4ELV7Z65AP)  
    SUCRALOSE (UNII: 96K6UQ3ZD4)  
    CROSPOVIDONE, UNSPECIFIED (UNII: 2S7830E561)  
    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:63868-158-24 4 in 1 CARTON 01/28/2005 09/26/2020
    1 6 in 1 BLISTER PACK; 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 09/26/2020
    Labeler - CHAIN DRUG MARKETING ASSOCIATION INC (011920774)
    Establishment
    Name Address ID/FEI Business Operations
    LNK International, Inc. 832867894 MANUFACTURE(63868-158)
    Establishment
    Name Address ID/FEI Business Operations
    LNK International, Inc. 038154464 PACK(63868-158)
    Establishment
    Name Address ID/FEI Business Operations
    LNK International, Inc. 832867837 PACK(63868-158)
    Establishment
    Name Address ID/FEI Business Operations
    LNK International, Inc. 967626305 PACK(63868-158)
    Establishment
    Name Address ID/FEI Business Operations
    LNK International, Inc. 868734088 PACK(63868-158)
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