Label: ARTHRITIS PAIN RELIEVER- acetaminophen tablet, film coated, extended release

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

Drug Label Information

Updated January 9, 2024

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  • 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). 

  • INACTIVE INGREDIENTS

    croscarmellose sodium, D&C red no. 30 aluminum lake, FD&C yellow no. 6 aluminum lake, hypromellose, magnesium stearate, microcrystalline cellulose, povidone, pregelatinized starch, propylene glycol, sodium lauryl sulfate, stearic acid, titanium dioxide

  • QUESTIONS?

    call 1-855-361-3993

    Contains No Aspirin

    Keep the carton. It contains important information.

    0115

    Distributed by:

    Ohm Laboratories Inc.

    1385 Livingston Avenue

    North Brunswick, NJ 08902

  • PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

    NDC 50268-052-15
    Acetaminophen Extended-release Tablets USP
    Arthritis Pain Relief
    650 mg
    50 Tablets (5 X 10) Unit Dose

    NDC 50268-052-15
    Acetaminophen Extended-release Tablets USP
    Arthritis Pain Relief
    650 mg
    50 Tablets (5 X 10) Unit Dose

    DO NOT USE WITH OTHER MEDICINES CONTAINING ACETAMINOPHEN.

    Use only as directed.

    Manufactured for: AvKARE, Inc.   Pulaski, TN 38478

    Mfg. Rev. R0315        AV 02/16 (P)

    AvPAK
    A PRODUCT OF AvKARE

    label 1
    label 2
    label 3
  • INGREDIENTS AND APPEARANCE
    ARTHRITIS PAIN RELIEVER 
    acetaminophen tablet, film coated, extended release
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:50268-052(NDC:51660-333)
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ACETAMINOPHEN (UNII: 362O9ITL9D) (ACETAMINOPHEN - UNII:362O9ITL9D) ACETAMINOPHEN650 mg
    Inactive Ingredients
    Ingredient NameStrength
    CROSCARMELLOSE SODIUM (UNII: M28OL1HH48)  
    HYPROMELLOSES (UNII: 3NXW29V3WO)  
    MAGNESIUM STEARATE (UNII: 70097M6I30)  
    CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)  
    SODIUM LAURYL SULFATE (UNII: 368GB5141J)  
    STEARIC ACID (UNII: 4ELV7Z65AP)  
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
    STARCH, CORN (UNII: O8232NY3SJ)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    POVIDONE, UNSPECIFIED (UNII: FZ989GH94E)  
    Product Characteristics
    ColorwhiteScoreno score
    ShapeOVALSize19mm
    FlavorImprint Code cor116
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:50268-052-1550 in 1 BOX, UNIT-DOSE03/07/2016
    1NDC:50268-052-111 in 1 BLISTER PACK; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    ANDAANDA07620003/07/2016
    Labeler - AvPAK (832926666)
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