PAIN RELIEVER EXTRA STRENGTH (ACETAMINOPHEN) TABLET, FILM COATED [WALGREEN COMPANY]

PAIN RELIEVER EXTRA STRENGTH (ACETAMINOPHEN) TABLET, FILM COATED [WALGREEN COMPANY]
PDF | XML

NDC 0363-0175-08, 0363-0175-12, 0363-0175-14, 0363-0175-15, 0363-0175-20, 0363-0175-29, 0363-0175-37, 0363-0175-57, 0363-0175-99
Set ID f7667529-09c0-4603-8080-f236144fac36
Category HUMAN OTC DRUG LABEL
Packager Walgreen Company
Generic Name
Product Class
Product Number
Application Number PART343
  • 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
    • redness or swelling is present
    • new symptoms occur

    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 15°-30°C (59°-86°F)
    • 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

    Walgreens

    Compare to Tylenol® Extra Strength Caplets active ingredient††

    NDC 0363-0175-08

    Pain Reliever
    ACETAMINOPHEN 500 mg / PAIN RELIEVER / FEVER REDUCER

    EXTRA STRENGTH  CAPLETS


    24 CAPLETS

    ACTUAL SIZE

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

    PHARMACIST Walgreens Trusted since 1901™ RECOMMENDED†
    Health expertise you rely on.™

    †Walgreens Pharmacist Survey

    ††This product is not manufactured or distributed by Johnson & Johnson Corporation, owner of the registered trademark Tylenol® Extra Strength Caplets.

    50844    ORG061717508

    DISTRIBUTED BY: WALGREEN CO.
    200 WILMOT RD., DEERFIELD, IL 60015
    100% SATISFACTION GUARANTEED
    walgreens.com    ©2017 Walgreen Co.

    Walgreens 44-175

    Walgreens 44-175

  • INGREDIENTS AND APPEARANCE
    PAIN RELIEVER  EXTRA STRENGTH
    acetaminophen tablet, film coated
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:0363-0175
    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)  
    POVIDONE, UNSPECIFIED (UNII: FZ989GH94E)  
    SODIUM STARCH GLYCOLATE TYPE A POTATO (UNII: 5856J3G2A2)  
    STARCH, CORN (UNII: O8232NY3SJ)  
    STEARIC ACID (UNII: 4ELV7Z65AP)  
    Product Characteristics
    ColorwhiteScoreno score
    ShapeOVALSize17mm
    FlavorImprint Code 44;175
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:0363-0175-371 in 1 CARTON04/02/199302/07/2021
    175 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product
    2NDC:0363-0175-571 in 1 CARTON04/02/199302/07/2021
    2125 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product
    3NDC:0363-0175-0310 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product04/02/1993
    4NDC:0363-0175-121 in 1 CARTON04/02/1993
    4100 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product
    5NDC:0363-0175-29150 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product04/02/1993
    6NDC:0363-0175-081 in 1 CARTON04/02/1993
    624 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product
    7NDC:0363-0175-14500 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product04/02/1993
    8NDC:0363-0175-151 in 1 CARTON04/02/1993
    850 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product
    9NDC:0363-0175-201 in 1 CARTON04/02/1993
    9225 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product
    10NDC:0363-0175-991 in 1 CARTON04/02/1993
    1024 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 - Walgreen Company (008965063)
    Establishment
    NameAddressID/FEIBusiness Operations
    LNK International, Inc.038154464pack(0363-0175)
    Establishment
    NameAddressID/FEIBusiness Operations
    LNK International, Inc.832867837manufacture(0363-0175) , pack(0363-0175)
    Establishment
    NameAddressID/FEIBusiness Operations
    LNK International, Inc.868734088pack(0363-0175)
    Establishment
    NameAddressID/FEIBusiness Operations
    LNK International, Inc.967626305pack(0363-0175)