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

  • Category: HUMAN OTC DRUG LABEL

Drug Label Information

Updated June 7, 2022

If you are a healthcare professional or from the pharmaceutical industry please visit this version.

View All Sections
  • 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° to 25°C (68° to 77°F). Avoid excessive heat 40°C (104°F).
    • FOR YOUR PROTECTION: Do not use if blister is torn or broken.
    • supplied as unit dose packages of 30 (5 x 6) NDC 68084-777-25
  • Inactive ingredients

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

  • Questions?

    • about the drug product, call Sun Pharmaceutical Industries, Inc. at 1-800-406-7984
    • about the packaging, call American Health Packaging at 1-800-707-4621

    Contains No Aspirin

    PACKAGING INFORMATION
    American Health Packaging unit dose blisters contain drug product from Ohm Laboratories Inc. as follows:
    (650 mg / 30 UD) NDC 68084-777-25 packaged from NDC 51660-333

    Distributed by:
    American Health Packaging
    Columbus, OH 43217

    8277725/0121

  • Principal Display Panel – Carton – 650 mg

    650 mg Acetaminophen Extended-release Tablets Carton

    NDC 68084- 777-25

    Acetaminophen
    Extended-release Tablets, USP
    Pain Reliever/Fever Reducer

    650 mg

    30 Tablets (5 x 6)

    DO NOT USE WITH OTHER MEDICINES
    CONTAINING ACETAMINOPHEN.

    Drug Facts

    Active Ingredient                 Purpose
    (in each caplet)
    Acetaminophen USP, 650 mg ................. Pain reliever/fever reducer

    Uses
    See package insert for complete Drug Facts information.

    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.

    Keep out of reach of children.

    See package insert for additional Drug Facts warnings.

    Directions
    • do not take more than directed, see package insert for
    overdose warning and complete Drug Facts information.

    Other Information • store at 20° to 25°C (68° to 77°F).

    Avoid excessive heat 40°C (104°F). • FOR YOUR
    PROTECTION: Do not use product if blister is torn or broken.

    Contains No Aspirin

    The drug product contained in this package is
    from NDC # 51660-333, Ohm Laboratories Inc.

    Distributed by: American Health Packaging
    2550 John Glenn Avenue, Suite A
    Columbus, OH 43217

    077725
    0277725/0222

  • Principal Display Panel – Blister – 650 mg

    650 mg Acetaminophen Extended-release Tablet Blister

    Acetaminophen
    Extended-release
    Tablet, USP
    Pain Reliever/
    Fever Reducer

    650 mg

  • INGREDIENTS AND APPEARANCE
    ARTHRITIS PAIN RELIEVER 
    acetaminophen tablet, film coated, extended release
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:68084-777(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
    CROSPOVIDONE (UNII: 2S7830E561)  
    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)  
    Product Characteristics
    ColorwhiteScoreno score
    ShapeOVAL (Capsule Shaped) Size19mm
    FlavorImprint Code cor116
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:68084-777-2530 in 1 BOX, UNIT-DOSE08/18/2014
    1NDC:68084-777-951 in 1 BLISTER PACK; Type 0: Not a Combination Product
    Image of Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    ANDAANDA07620008/18/2014
    Labeler - American Health Packaging (929561009)
    Establishment
    NameAddressID/FEIBusiness Operations
    American Health Packaging929561009repack(68084-777)
View All Sections

Find additional resources

(also available in the left menu)

Safety

Report Adverse Events, FDA Safety Recalls, Presence in Breast Milk

Related Resources

Medline Plus, Clinical Trials

More Info on this Drug

Get Label RSS Feed, View NDC Code(s)NEW!