PAIN RELIEF EXTRA STRENGTH (ACETAMINOPHEN) TABLET, FILM COATED [BETTER LIVING BRANDS, LLC]

  • Home
  • PAIN RELIEF EXTRA STRENGTH (ACETAMINOPHEN) TABLET, FILM COATED [BETTER LIVING BRANDS, LLC]

PAIN RELIEF EXTRA STRENGTH (ACETAMINOPHEN) TABLET, FILM COATED [BETTER LIVING BRANDS, LLC]
PDF | XML
NDC 21130-975-29
Set ID e4dea44e-9876-4900-8531-cc6a11c5bef2
Category HUMAN OTC DRUG LABEL
Packager Better Living Brands, LLC
Generic Name
Product Class
Product Number
Application Number PART343
View All Sections
  • Active ingredient (in each caplet)

    Acetaminophen 500 mg

  • Purpose

    Pain reliever/fever reducer 

  • Uses

    • temporarily relieves minor aches and pains due to:
      • headache
      • the common cold
      • backache
      • minor pain of arthritis
      • toothache
      • muscular aches
      • premenstrual and menstrual cramps
    • temporarily reduces fever 
  • 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.

    Do not use

    • if you are allergic to acetaminophen or any of the inactive ingredients in this product
    • with any other drug containing acetaminophen (prescription or nonprescription). If you are not sure whether a drug contains acetaminophen, ask a doctor or pharmacist. 

    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.

    In case of accidental overdose, get medical help or contact a Poison Control Center (1-800-222-1222) right away. Prompt 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
    • adults and children 12 years and over
      • take 2 caplets every 6 hours while symptoms last
      • do not take more than 6 caplets 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 at 25ºC (77ºF); excursions permitted between 15º-30ºC (59º-86ºF)
    • see end flap for expiration date and lot number 
  • Inactive ingredients

    castor oil, hypromellose, povidone, sodium starch glycolate, starch, stearic acid 

  • Questions or comments?

    1-800-426-9391 

  • Principal Display Panel

    Signature™
    care 

    Quality Guaranteed

    Compare to
    Extra Strength
    Tylenol® Caplets
    active ingredient*

    NDC 21130-975-29

    Extra Strength
    Pain Relief

    ACETAMINOPHEN 500 mg

    Pain Reliever /
    Fever Reducer

    • Contains no aspirin

    Actual Size

    150 CAPLETS

    *This product is not manufactured or distributed by
    Johnson & Johnson Corporation, distributors of
    Extra Strength Tylenol® Caplets.
    50844      REV0617A17529

    DISTRIBUTED BY
    BETTER LIVING BRANDS LLC
    P.O. BOX 99, PLEASANTON, CA 94566-0009
    1-888-723-3929
    www.betterlivingbrandsLLC.com

    OUR PROMISE
    QUALITY & SATISFACTION
    100% GUARANTEED
    OR YOUR MONEY BACK.

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

    Signature Care 44-175

    Signature Care 44-175



  • INGREDIENTS AND APPEARANCE
    PAIN RELIEF  EXTRA STRENGTH
    acetaminophen tablet, film coated
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:21130-975
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ACETAMINOPHEN (UNII: 362O9ITL9D) (ACETAMINOPHEN - UNII:362O9ITL9D) ACETAMINOPHEN500 mg
    Inactive Ingredients
    Ingredient NameStrength
    CASTOR OIL (UNII: D5340Y2I9G)  
    HYPROMELLOSE, UNSPECIFIED (UNII: 3NXW29V3WO)  
    STEARIC ACID (UNII: 4ELV7Z65AP)  
    POVIDONE, UNSPECIFIED (UNII: FZ989GH94E)  
    SODIUM STARCH GLYCOLATE TYPE A POTATO (UNII: 5856J3G2A2)  
    STARCH, CORN (UNII: O8232NY3SJ)  
    Product Characteristics
    ColorwhiteScoreno score
    ShapeOVALSize17mm
    FlavorImprint Code 44;175
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:21130-975-291 in 1 CARTON04/02/1993
    1150 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart34304/02/1993
    Labeler - Better Living Brands, LLC (009137209)
    Establishment
    NameAddressID/FEIBusiness Operations
    LNK International, Inc.038154464pack(21130-975)
    Establishment
    NameAddressID/FEIBusiness Operations
    LNK International, Inc.832867837manufacture(21130-975) , pack(21130-975)
    Establishment
    NameAddressID/FEIBusiness Operations
    LNK International, Inc.967626305pack(21130-975)
    Establishment
    NameAddressID/FEIBusiness Operations
    LNK International, Inc.868734088pack(21130-975)
View All Sections

Related Drugs

Search DailyMed Drugs