Label: ACETAMINOPHEN JUNIOR STRENGTH- 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 November 29, 2017

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 the 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

    • do not give more than directed (see overdose warning)
    • 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.
    • 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 48 Under 6 Ask a doctor
    48-59 6-8 2
    60-71 9-10 2 1/2
    72-95 11 3

    *or as directed by a doctor

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  • Other information

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

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

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  • Principal Display Panel

    EQUALINE®

    compare to
    Junior Strength
    Tylenol® Meltaways® 

    active ingredients**

    NDC 41163-450-08

    junior strength
    acetaminophen
    160mg, rapid tabs
    pain reliever/fever reducer

    for ages 6-11
    bubble gum flavor

    • fast dissolving
    • aspirin free
    • ibuprofen free

    24 rapid tablets

    actual size

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

    DOES NOT CONTAIN GLUTEN

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

    50844    REV1013G45008

    We're committed to your
    satisfaction and guarantee
    the quality of this product.
    Contact us at 1-877-932-7948, or
    www.supervalu-ourownbrands.com.
    Please have package available.

    DISTRIBUTED BY SUPERVALU INC.
    EDEN PRARITE, MN 55344 USA

    Equaline 44-450

    Equaline 44-450

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  • INGREDIENTS AND APPEARANCE
    ACETAMINOPHEN  JUNIOR STRENGTH
    acetaminophen tablet, chewable
    Product Information
    Product Type HUMAN OTC DRUG Item Code (Source) NDC:41163-450
    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 (UNII: 2LRS185U6K)  
    D&C RED NO. 30 (UNII: 2S42T2808B)  
    ETHYLCELLULOSE, UNSPECIFIED (UNII: 7Z8S9VYZ4B)  
    MAGNESIUM STEARATE (UNII: 70097M6I30)  
    MANNITOL (UNII: 3OWL53L36A)  
    STEARIC ACID (UNII: 4ELV7Z65AP)  
    SUCRALOSE (UNII: 96K6UQ3ZD4)  
    CROSPOVIDONE (UNII: 2S7830E561)  
    Product Characteristics
    Color PINK Score 2 pieces
    Shape ROUND Size 16mm
    Flavor BUBBLE GUM Imprint Code 44;450
    Contains     
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NDC:41163-450-08 4 in 1 CARTON 02/25/2005 08/10/2020
    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 02/25/2005 08/10/2020
    Labeler - SUPERVALU INC. (006961411)
    Establishment
    Name Address ID/FEI Business Operations
    LNK International, Inc. 038154464 PACK(41163-450)
    Establishment
    Name Address ID/FEI Business Operations
    LNK International, Inc. 832867894 MANUFACTURE(41163-450)
    Establishment
    Name Address ID/FEI Business Operations
    LNK International, Inc. 832867837 PACK(41163-450)
    Establishment
    Name Address ID/FEI Business Operations
    LNK International, Inc. 967626305 PACK(41163-450)
    Establishment
    Name Address ID/FEI Business Operations
    LNK International, Inc. 868734088 PACK(41163-450)
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