Label: ACETAMINOPHEN tablet, extended release

  • NDC Code(s): 62207-183-34, 62207-183-49, 62207-183-51, 62207-183-87, view more
    62207-183-97, 62207-188-49, 62207-188-51
  • Packager: Granules India Limited
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: Abbreviated New Drug Application

Drug Label Information

Updated January 27, 2023

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

  • ACTIVE INGREDIENT (IN EACH CAPLET)

    Acetaminophen USP,  650 mg

  • PURPOSE

    Pain reliever/fever reducer

  • USES

    For Arthritis Pain label
    • 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

    For Muscle Aches & Pain label
    • temporarily relieves minor aches and pains due to:
        • muscular aches
        • backache
        • minor pain of arthritis
        • toothache
        • premenstrual and menstrual cramps
        • headache
        • the common cold
    • 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 everyday 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 drugs 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 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

    For Arthritis Pain Label
    •  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


    For Muscle Ache and Pain label
    • do not take more than directed (see overdose warning)


     adults and children
    12 years of age and over
     • 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
     children under
    12 years
     • do not use
  • OTHER INFORMATION

    • store between 20-25°C (68-77°F)
    • do not use if foil inner seal is broken or missing.

  • INACTIVE INGREDIENTS

    hydroxyethyl cellulose, hypromellose, magnesium stearate, microcrystalline cellulose, polyethylene glycol, povidone, pregelatinized starch, sodium starch glycolate, stearic acid

  • QUESTIONS OR COMMENTS ?

    Contact 1-877-770-3183 Mon-Fri 8:00 AM EST to 5:00 PM PST.

  • PRINCIPAL DISPLAY PANEL

    acetaminophen-er-650mg-bulk-jpgacetaminophen-label2-jpgacetaminophen-label1-jpgacetaminophen-label2acetaminophen-label3acetaminophen-label4acetaminophen-eracetaminophen-650mgacetaminophen-650mg-label1.jpg

  • INGREDIENTS AND APPEARANCE
    ACETAMINOPHEN 
    acetaminophen tablet, extended release
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:62207-188
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ACETAMINOPHEN (UNII: 362O9ITL9D) (ACETAMINOPHEN - UNII:362O9ITL9D) ACETAMINOPHEN650 mg
    Inactive Ingredients
    Ingredient NameStrength
    HYPROMELLOSE 2910 (6 MPA.S) (UNII: 0WZ8WG20P6)  
    MAGNESIUM STEARATE (UNII: 70097M6I30)  
    POVIDONE K30 (UNII: U725QWY32X)  
    STARCH, CORN (UNII: O8232NY3SJ)  
    STEARIC ACID (UNII: 4ELV7Z65AP)  
    SODIUM STARCH GLYCOLATE TYPE A CORN (UNII: AG9B65PV6B)  
    HYDROXYETHYL CELLULOSE (140 CPS AT 5%) (UNII: 8136Y38GY5)  
    MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U)  
    POLYETHYLENE GLYCOL 400 (UNII: B697894SGQ)  
    Product Characteristics
    ColorwhiteScoreno score
    ShapeCAPSULESize19mm
    FlavorImprint Code G650
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:62207-188-511 in 1 CARTON04/18/2019
    110 in 1 BOTTLE; Type 0: Not a Combination Product
    2NDC:62207-188-491000 in 1 BOTTLE; Type 0: Not a Combination Product04/18/2019
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    ANDAANDA21154404/18/2019
    ACETAMINOPHEN 
    acetaminophen tablet, extended release
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:62207-183
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ACETAMINOPHEN (UNII: 362O9ITL9D) (ACETAMINOPHEN - UNII:362O9ITL9D) ACETAMINOPHEN650 mg
    Inactive Ingredients
    Ingredient NameStrength
    HYDROXYETHYL CELLULOSE (140 MPA.S AT 5%) (UNII: 8136Y38GY5)  
    HYPROMELLOSE 2910 (6 MPA.S) (UNII: 0WZ8WG20P6)  
    MAGNESIUM STEARATE (UNII: 70097M6I30)  
    CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)  
    POLYETHYLENE GLYCOL 400 (UNII: B697894SGQ)  
    POVIDONE K30 (UNII: U725QWY32X)  
    STARCH, CORN (UNII: O8232NY3SJ)  
    SODIUM STARCH GLYCOLATE TYPE A CORN (UNII: AG9B65PV6B)  
    STEARIC ACID (UNII: 4ELV7Z65AP)  
    Product Characteristics
    ColorwhiteScoreno score
    ShapeCAPSULESize19mm
    FlavorImprint Code G650
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:62207-183-511 in 1 CARTON04/18/2019
    110 in 1 BOTTLE; Type 0: Not a Combination Product
    2NDC:62207-183-341 in 1 BOX06/30/2019
    25 in 1 POUCH; Type 0: Not a Combination Product
    3NDC:62207-183-871 in 1 BOX06/30/2019
    31 in 1 POUCH; Type 0: Not a Combination Product
    4NDC:62207-183-491000 in 1 BOTTLE; Type 0: Not a Combination Product04/18/2019
    5NDC:62207-183-9740000 in 1 DRUM; Type 0: Not a Combination Product03/25/2021
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    ANDAANDA21154404/18/2019
    Labeler - Granules India Limited (915000087)
    Registrant - Granules India Limited (915000087)