Label: ACETAMINOPHEN tablet

  • NDC Code(s): 71335-1536-0, 71335-1536-1, 71335-1536-2, 71335-1536-3, view more
    71335-1536-4, 71335-1536-5, 71335-1536-6, 71335-1536-7, 71335-1536-8, 71335-1536-9
  • Packager: Bryant Ranch Prepack
  • This is a repackaged label.
  • Source NDC Code(s): 0904-6730
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None

Drug Label Information

Updated May 30, 2024

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

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  • Drug Facts

    Active Ingredient (in each tablet)

    Acetaminophen 500 mg

  • PURPOSE

    Purpose

    Pain reliever/ Fever reducer

  • Uses

    Temporarily reduces fever and relieves minor aches and pains due to:

    • headache
    • muscular aches
    • backache
    • minor pain of arthritis
    • the common cold
    • toothache
    • premenstrual and menstrual cramps
  • WARNINGS

    Liver warning: This product contains acetaminophen. Severe liver damage may occur if you take

    • more than 4,000 mg of acetaminophen in 24 hours
    • 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.

    • 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 and children 12 years and over:

    • take 2 tablets every 6 hours while symptoms last

    • do not take more than 6 tablets in 24 hours, unless directed by a doctor

    • do not take for more than 10 days unless directed by a doctor

    children under 12 years: ask a doctor

  • Other Information

    store in a dry place at 15° – 30°C (59° – 86°F).

  • INACTIVE INGREDIENT

    Povidone, pregelatinized starch, sodium starch glycolate, stearic acid

  • Questions or comments?

    Call 1-800-231-4670

  • SPL UNCLASSIFIED SECTION

    TAMPER EVIDENT: DO NOT USE IF IMPRINTED SAFETY SEAL UNDER CAP IS BROKEN OR MISSING

    Distributed by:

    MAJOR® PHARMACEUTICALS
    Indianapolis, IN 46268

    *This product is not manufactured or distributed by Kenvue Inc., owner of the registered trademark Tylenol®.

  • HOW SUPPLIED

    Acetaminophen Tablets 500 mg

    • NDC: 71335-1536-1: 20 Tablets in a BOTTLE
    • NDC: 71335-1536-2: 15 Tablets in a BOTTLE
    • NDC: 71335-1536-3: 40 Tablets in a BOTTLE
    • NDC: 71335-1536-4: 100 Tablets in a BOTTLE
    • NDC: 71335-1536-5: 30 Tablets in a BOTTLE
    • NDC: 71335-1536-6: 45 Tablets in a BOTTLE
    • NDC: 71335-1536-7: 50 Tablets in a BOTTLE
    • NDC: 71335-1536-8: 60 Tablets in a BOTTLE
    • NDC: 71335-1536-9: 90 Tablets in a BOTTLE
    • NDC: 71335-1536-0: 250 Tablets in a BOTTLE

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

  • PRINCIPAL DISPLAY PANEL

    Acetaminophen Tablets 500 mg

    Label
  • INGREDIENTS AND APPEARANCE
    ACETAMINOPHEN 
    acetaminophen tablet
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:71335-1536(NDC:0904-6730)
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ACETAMINOPHEN (UNII: 362O9ITL9D) (ACETAMINOPHEN - UNII:362O9ITL9D) ACETAMINOPHEN500 mg
    Inactive Ingredients
    Ingredient NameStrength
    STARCH, CORN (UNII: O8232NY3SJ)  
    STEARIC ACID (UNII: 4ELV7Z65AP)  
    POVIDONE K30 (UNII: U725QWY32X)  
    SODIUM STARCH GLYCOLATE TYPE A POTATO (UNII: 5856J3G2A2)  
    Product Characteristics
    ColorwhiteScore2 pieces
    ShapeROUNDSize12mm
    FlavorImprint Code 54;27
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:71335-1536-120 in 1 BOTTLE; Type 0: Not a Combination Product05/30/2024
    2NDC:71335-1536-215 in 1 BOTTLE; Type 0: Not a Combination Product05/30/2024
    3NDC:71335-1536-340 in 1 BOTTLE; Type 0: Not a Combination Product05/30/2024
    4NDC:71335-1536-4100 in 1 BOTTLE; Type 0: Not a Combination Product04/17/2020
    5NDC:71335-1536-530 in 1 BOTTLE; Type 0: Not a Combination Product06/16/2020
    6NDC:71335-1536-645 in 1 BOTTLE; Type 0: Not a Combination Product05/30/2024
    7NDC:71335-1536-750 in 1 BOTTLE; Type 0: Not a Combination Product05/30/2024
    8NDC:71335-1536-860 in 1 BOTTLE; Type 0: Not a Combination Product05/30/2024
    9NDC:71335-1536-990 in 1 BOTTLE; Type 0: Not a Combination Product05/30/2024
    10NDC:71335-1536-0250 in 1 BOTTLE; Type 0: Not a Combination Product05/30/2024
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph DrugM01309/12/2018
    Labeler - Bryant Ranch Prepack (171714327)
    Registrant - Bryant Ranch Prepack (171714327)
    Establishment
    NameAddressID/FEIBusiness Operations
    Bryant Ranch Prepack171714327REPACK(71335-1536) , RELABEL(71335-1536)
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