Label: ACETAMINOPHEN tablet, extended release

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

Drug Label Information

Updated July 7, 2020

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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 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

    • 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 between 20-25°C (68-77°F)

  • INACTIVE INGREDIENTS

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

  • QUESTIONS OR COMMENTS ?

    1-800-540-3765

  • HOW SUPPLIED

    Product: 71335-1340

    NDC: 71335-1340-1 30 TABLET, EXTENDED RELEASE in a BOTTLE

    NDC: 71335-1340-2 100 TABLET, EXTENDED RELEASE in a BOTTLE

    NDC: 71335-1340-3 50 TABLET, EXTENDED RELEASE in a BOTTLE

    NDC: 71335-1340-4 60 TABLET, EXTENDED RELEASE in a BOTTLE

    NDC: 71335-1340-5 120 TABLET, EXTENDED RELEASE in a BOTTLE

  • Acetaminophen ER 650mg Tablet

    Label Image
  • INGREDIENTS AND APPEARANCE
    ACETAMINOPHEN 
    acetaminophen tablet, extended release
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:71335-1340(NDC:57896-268)
    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)  
    MICROCRYSTALLINE CELLULOSE (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:71335-1340-130 in 1 BOTTLE; Type 0: Not a Combination Product07/01/2019
    2NDC:71335-1340-2100 in 1 BOTTLE; Type 0: Not a Combination Product07/01/2019
    3NDC:71335-1340-350 in 1 BOTTLE; Type 0: Not a Combination Product07/01/2019
    4NDC:71335-1340-460 in 1 BOTTLE; Type 0: Not a Combination Product07/01/2019
    5NDC:71335-1340-5120 in 1 BOTTLE; Type 0: Not a Combination Product07/01/2019
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    ANDAANDA21154407/01/2019
    Labeler - Bryant Ranch Prepack (171714327)
    Establishment
    NameAddressID/FEIBusiness Operations
    Bryant Ranch Prepack171714327REPACK(71335-1340) , RELABEL(71335-1340)
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