Label: ACETAMINOPHEN EXTRA STRENGTH- acetaminophen tablet

  • NDC Code(s): 46994-175-12
  • Packager: SAVE-A-LOT FOOD STORES, LTD.
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: OTC monograph not final

NOTE: Most over the counter (OTC) are not reviewed and approved by the FDA. However, they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

Drug Label Information

Updated 06/15

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  • Active ingredient (in each caplet)

    Acetaminophen 500 mg

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  • Purpose

    Pain reliever/fever reducer

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  • 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
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  • Warnings

    Liver warning: This product contains acetaminophen. The maximum daily dose of this product is 6 caplets (3,000 mg) in 24 hours. 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 of breast-feeding,

    ask a health professional before use.

    Keep out of reach of children.

    In case of overdose, get medical help or contact a Poison Control Center (1-800-222-1222) right away. 

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  • Directions

    • do not take more than directed (see overdose warning)
    • 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
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  • Other information

    • store at 25ºC (77ºF); excursions permitted between 15°-30°C (59°-86°F)
    • see end flap for expiration date and lot number
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  • Inactive ingredients

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

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  • Principal Display Panel

    COMPARE TO THE ACTIVE INGREDIENT IN EXTRA STRENGTH TYLENOL® CAPLETS*

    Acetaminophen
    EXTRA STRENGTH

    Acetaminophen, 500 mg

    PAIN RELIEVER/FEVER REDUCER

    Actual
    size

    BEING WELL®

    100
    CAPLETS

    *This product is not manufactured or distributed by McNeil Consumer Healthcare, owner of the registered trademark Extra Strength Tylenol® Caplets.
    50844    REV0315E17512

    DISTRIBUTED BY:
    SAVE-A-LOT FOOD STORES, LTD.
    EARTH CITY, MO 63045
    savealot.com

    Save
    a lot

    promise
    100% MONEY BACK
    GUARANTEE

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

    Being Well 44-175

    Being Well 44-175

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  • INGREDIENTS AND APPEARANCE
    ACETAMINOPHEN  EXTRA STRENGTH
    acetaminophen tablet
    Product Information
    Product Type HUMAN OTC DRUG Item Code (Source) NDC:46994-175
    Route of Administration ORAL DEA Schedule     
    Active Ingredient/Active Moiety
    Ingredient Name Basis of Strength Strength
    ACETAMINOPHEN (UNII: 362O9ITL9D) (ACETAMINOPHEN - UNII:362O9ITL9D) ACETAMINOPHEN 500 mg
    Inactive Ingredients
    Ingredient Name Strength
    HYPROMELLOSES (UNII: 3NXW29V3WO)  
    POVIDONES (UNII: FZ989GH94E)  
    STEARIC ACID (UNII: 4ELV7Z65AP)  
    CASTOR OIL (UNII: D5340Y2I9G)  
    SODIUM STARCH GLYCOLATE TYPE A POTATO (UNII: 5856J3G2A2)  
    Product Characteristics
    Color WHITE Score no score
    Shape OVAL Size 16mm
    Flavor Imprint Code 44;175
    Contains     
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NDC:46994-175-12 1 in 1 CARTON
    1 100 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    OTC MONOGRAPH NOT FINAL part343 04/02/1993
    Labeler - SAVE-A-LOT FOOD STORES, LTD. (095484572)
    Establishment
    Name Address ID/FEI Business Operations
    LNK International, Inc. 832867894 MANUFACTURE(46994-175)
    Establishment
    Name Address ID/FEI Business Operations
    LNK International, Inc. 038154464 PACK(46994-175)
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