Label: ACETAMINOPHEN tablet, film coated, extended release

  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: Abbreviated New Drug Application

Drug Label Information

Updated July 6, 2020

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  • SPL UNCLASSIFIED SECTION

    Drug Facts

  • Active ingredient (in each caplet)

    Acetaminophen USP, 650 mg

  • Purpose

    Pain reliever/fever reducer

  • Uses

    •
    temporarily relieves minor aches and pains due to:
    •
    minor pain of arthritis
    •
    muscular aches
    •
    backache
    •
    premenstrual and menstrual cramps
    •
    the common cold
    •
    headache
    •
    toothache
    •
    temporarily reduces fever
  • Warnings

    Liver warning

    This product contains acetaminophen. Severe liver damage may occur if you take

    •
    more than 6 caplets in 24 hours, which is the maximum daily amount
    •
    with other drugs containing acetaminophen
    •
    3 or more alcoholic drinks every day while using this product

    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.

    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 you are allergic to acetaminophen or any of the inactive ingredients in this product.

    Ask a doctor before use if you have liver disease.

    Ask a doctor or pharmacist before use if you are taking the blood thinning drug warfarin.

    Stop use and ask a doctor if

    •
    pain gets worse or lasts more than 10 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.

    If pregnant or breast-feeding, ask a health professional before use.

    Keep out of reach of children.

    Overdose warning

    In case of overdose, get medical help or contact a Poison Control Center right away (1-800-222-1222). Quick medical attention is critical for adults as well as for children even if you do not notice any signs or symptoms.

  • Directions

    •
    do not take more than directed (see overdose warning)

    adults
    •
    take 2 caplets every 8 hours with water
    •
    swallow whole; do not crush, chew, split or dissolve
    •
    do not take more than 6 caplets in 24 hours
    •
    do not use for more than 10 days unless directed by a doctor

    under 18 years of age
    •
    ask a doctor
  • Other information

    •
    store at 20 - 25° C (68 - 77° F). Avoid excessive heat 40° C (104° F).
    •
    see end panel for batch number and expiration date
    •
    TAMPER EVIDENT: DO NOT USE IF IMPRINTED SEAL IS BROKEN OR MISSING FROM BOTTLE.
  • Inactive ingredients

    crospovidone, hypromellose, magnesium stearate, microcrystalline cellulose, povidone, pregelatinized starch, propylene glycol, sodium lauryl sulfate, stearic acid, titanium dioxide

  • Questions?

    call 1-800-406-7984

  • SPL UNCLASSIFIED SECTION

    DISTRIBUTED BY: MIDWOOD BRANDS, LLC
    500 Volvo Parkway, Chesapeake, VA 23320 USA

  • PRINCIPAL DISPLAY PANEL - 650 mg Caplet Bottle Carton

    FAMILY
    wellness™

    COMPARE TO
    TYLENOL® ARTHRITIS PAIN*

    EASY
    TO OPEN
    BOTTLE

    Use only as directed.
    NDC 55319-333-01

    ARTHRITIS
    Pain Relief
    Acetaminophen Extended-release Tablets USP, 650 mg
    Pain Reliever/Fever Reducer

    •
    For the Temporary Relief of Minor Arthritis Pain

    Lasts up to
    8 Hours

    DO NOT USE WITH OTHER
    MEDICINES CONTAINING
    ACETAMINOPHEN

    ACTUAL SIZE

    THIS PACKAGE FOR
    HOUSEHOLDS WITHOUT
    YOUNG CHILDREN

    100% SATISFACTION
    OR YOUR MONEY BACK
    GUARANTEED

    100 CAPLETS* (*Capsule-Shaped Tablets)

    PRINCIPAL DISPLAY PANEL - 650 mg Caplet Bottle Carton
  • INGREDIENTS AND APPEARANCE
    ACETAMINOPHEN 
    acetaminophen tablet, film coated, extended release
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:55319-333
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ACETAMINOPHEN (UNII: 362O9ITL9D) (ACETAMINOPHEN - UNII:362O9ITL9D) ACETAMINOPHEN650 mg
    Inactive Ingredients
    Ingredient NameStrength
    HYPROMELLOSE, UNSPECIFIED (UNII: 3NXW29V3WO)  
    MAGNESIUM STEARATE (UNII: 70097M6I30)  
    MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U)  
    POVIDONE, UNSPECIFIED (UNII: FZ989GH94E)  
    STARCH, CORN (UNII: O8232NY3SJ)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    SODIUM LAURYL SULFATE (UNII: 368GB5141J)  
    STEARIC ACID (UNII: 4ELV7Z65AP)  
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
    CROSPOVIDONE, UNSPECIFIED (UNII: 2S7830E561)  
    Product Characteristics
    ColorwhiteScoreno score
    ShapeOVAL (Capsule Shaped) Size19mm
    FlavorImprint Code cor116
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:55319-333-2324 in 1 BOTTLE; Type 0: Not a Combination Product09/01/2017
    2NDC:55319-333-01100 in 1 BOTTLE; Type 0: Not a Combination Product05/30/2019
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    ANDAANDA07620009/01/2017
    Labeler - Family Dollar Services, Inc. (024472631)
    Registrant - Ohm Laboratories Inc. (051565745)
    Establishment
    NameAddressID/FEIBusiness Operations
    Ohm Laboratories Inc.051565745MANUFACTURE(55319-333)
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