PAIN RELIEVER EXTRA STRENGTH (ACETAMINOPHEN) TABLET, FILM COATED [SALADO SALES, INC.]

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  • PAIN RELIEVER EXTRA STRENGTH (ACETAMINOPHEN) TABLET, FILM COATED [SALADO SALES, INC.]

PAIN RELIEVER EXTRA STRENGTH (ACETAMINOPHEN) TABLET, FILM COATED [SALADO SALES, INC.]
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NDC 57243-175-15
Set ID 1dbd8480-5cb4-4577-9091-b2a2add4f1af
Category HUMAN OTC DRUG LABEL
Packager Salado Sales, Inc.
Generic Name
Product Class
Product Number
Application Number PART343
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  • Active ingredient (in each caplet)

    Acetaminophen 500 mg

  • Purpose

    Pain reliever/fever reducer

  • Uses

    • temporarily relieves minor aches and pains due to:
      • minor pain of arthritis
      • toothache
      • muscular aches
      • backache
      • headache
      • the common cold
      • 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

    • 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.

    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

    CVP®   
    HEALTH

    COMPARE TO
    EXTRA STRENGTH
    TYLENOL® CAPLETS
    ACTIVE INGREDIENT*

    EXTRA STRENGTH
    PAIN
    RELIEVER

    ACETAMINOPHEN
    PAIN RELIEVER/FEVER REDUCER

    NON-ASPIRIN

    EASY TO SWALLOW
    50
    CAPLETS
    500 mg EACH

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

    *This product is not manufactured or distributed by
    Johnson & Johnson Corporation, owner of the registered
    trademark Extra Strength Tylenol® Caplets.
    50844    REV0617S17515

    Distributed by Consumer Value Products, Inc.
    P.O. Box 6115, Temple, Texas 76502
    CVPproducts.com

    CVP 44-175

    CVP 44-175

  • INGREDIENTS AND APPEARANCE
    PAIN RELIEVER  EXTRA STRENGTH
    acetaminophen tablet, film coated
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:57243-175
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ACETAMINOPHEN (UNII: 362O9ITL9D) (ACETAMINOPHEN - UNII:362O9ITL9D) ACETAMINOPHEN500 mg
    Inactive Ingredients
    Ingredient NameStrength
    HYPROMELLOSE, UNSPECIFIED (UNII: 3NXW29V3WO)  
    POVIDONE, UNSPECIFIED (UNII: FZ989GH94E)  
    STEARIC ACID (UNII: 4ELV7Z65AP)  
    CASTOR OIL (UNII: D5340Y2I9G)  
    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:57243-175-151 in 1 CARTON04/02/1993
    150 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 - Salado Sales, Inc. (009830555)
    Establishment
    NameAddressID/FEIBusiness Operations
    LNK International, Inc.038154464pack(57243-175)
    Establishment
    NameAddressID/FEIBusiness Operations
    LNK International, Inc.832867837manufacture(57243-175) , pack(57243-175)
    Establishment
    NameAddressID/FEIBusiness Operations
    LNK International, Inc.868734088pack(57243-175)
    Establishment
    NameAddressID/FEIBusiness Operations
    LNK International, Inc.967626305pack(57243-175)
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