Label: ACETAMINOPHEN- acetaminophen tablet extended release tablet, extended release

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

Drug Label Information

Updated April 5, 2024

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  • ACTIVE INGREDIENT

    Active ingredient (in each caplet)

    Acetaminophen 650 mg

  • PURPOSE

    Purpose

    Pain reliever/fever reducer

  • INDICATIONS & USAGE

    Uses

    For Arthritis Pain

    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 & Pains

    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

    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

    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 DOCTOR

    Ask a doctor before use if you have liver disease.

  • ASK DOCTOR/PHARMACIST

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

  • STOP USE

    Stop using 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.

  • PREGNANCY OR BREAST FEEDING

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

  • KEEP OUT OF REACH OF CHILDREN

    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.

  • DOSAGE & ADMINISTRATION

    Directions

    For Arthritis Pain

    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 Aches & Pains

    Do not take more than directed. See overdose warning

    adults and children 12 years 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

  • STORAGE AND HANDLING

    Other information

    • store between 20-25°C (68-77°F)
    • The FDA approved Dissolution methods differ from USP
  • INACTIVE INGREDIENT

    Inactive ingredients carnauba wax, hydroxyethyl cellulose, hypromellose, magnesium stearate, microcrystalline cellulose, povidone, pregelatinized starch, sodium starch glycolate, titanium dioxide, triacetin

  • OTHER SAFETY INFORMATION

    Questions or comments?

    Call 1-877-290-4008

  • HOW SUPPLIED

    Acetaminophen Extended-Release 650 mg Tablet

    • NDC 71335-9746-1: 30 Tablets in a BOTTLE
    • NDC 71335-9746-2: 100 Tablets in a BOTTLE
    • NDC 71335-9746-3: 50 Tablets in a BOTTLE
    • NDC 71335-9746-4: 60 Tablets in a BOTTLE
    • NDC 71335-9746-5: 120 Tablets in a BOTTLE
    • NDC 71335-9746-6: 19 Tablets in a BOTTLE
    • NDC 71335-9746-7: 20 Tablets in a BOTTLE

    Repackaged/Relabeled by:
    Bryant Ranch Prepack, Inc.
    Burbank, CA 91504

  • PRINCIPAL DISPLAY PANEL

    Acetaminophen Extended-Release 650 mg Tablet

    Label
  • INGREDIENTS AND APPEARANCE
    ACETAMINOPHEN 
    acetaminophen tablet extended release tablet, extended release
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:71335-9746(NDC:49483-699)
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ACETAMINOPHEN (UNII: 362O9ITL9D) (ACETAMINOPHEN - UNII:362O9ITL9D) ACETAMINOPHEN650 mg
    Inactive Ingredients
    Ingredient NameStrength
    STARCH, CORN (UNII: O8232NY3SJ)  
    POVIDONE K30 (UNII: U725QWY32X)  
    MAGNESIUM STEARATE (UNII: 70097M6I30)  
    HYPROMELLOSE, UNSPECIFIED (UNII: 3NXW29V3WO)  
    TRIACETIN (UNII: XHX3C3X673)  
    CARNAUBA WAX (UNII: R12CBM0EIZ)  
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
    MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U)  
    SODIUM STARCH GLYCOLATE TYPE A (UNII: H8AV0SQX4D)  
    HYDROXYETHYL CELLULOSE (140 MPA.S AT 5%) (UNII: 8136Y38GY5)  
    Product Characteristics
    Colorwhite (White to off white) Scoreno score
    ShapeCAPSULESize19mm
    FlavorImprint Code 71
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:71335-9746-130 in 1 BOTTLE; Type 0: Not a Combination Product11/16/2023
    2NDC:71335-9746-2100 in 1 BOTTLE; Type 0: Not a Combination Product04/05/2024
    3NDC:71335-9746-350 in 1 BOTTLE; Type 0: Not a Combination Product04/05/2024
    4NDC:71335-9746-460 in 1 BOTTLE; Type 0: Not a Combination Product04/05/2024
    5NDC:71335-9746-5120 in 1 BOTTLE; Type 0: Not a Combination Product04/05/2024
    6NDC:71335-9746-619 in 1 BOTTLE; Type 0: Not a Combination Product04/05/2024
    7NDC:71335-9746-720 in 1 BOTTLE; Type 0: Not a Combination Product04/05/2024
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    ANDAANDA21548610/04/2021
    Labeler - Bryant Ranch Prepack (171714327)
    Registrant - Bryant Ranch Prepack (171714327)
    Establishment
    NameAddressID/FEIBusiness Operations
    Bryant Ranch Prepack171714327REPACK(71335-9746) , RELABEL(71335-9746)
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