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Members Mark Acetaminophen

Sam's West Inc

Sam's West, Inc. Acetaminophen Drug Facts


FULL PRESCRIBING INFORMATION: CONTENTS*




FULL PRESCRIBING INFORMATION

Active ingredient (in each caplet)

Acetaminophen 500 mg

Purpose

Pain reliever/fever reducer

Members Mark Acetaminophen Uses

  • •temporarily relieves minor aches and pains due to:
  • •the common cold
  • •headache
  • •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 8 caplets in 24 hours, which is the maximum daily amount
  • •with other drugs containing acetaminophen
  • •3 or more alcoholic drinks every day while using this product

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.

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 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 Liver warning)
take 2 caplets every 6 hours while symptoms last
  • do not take more than 8 caplets in 24 hours

    adults and children 12 years and over

    children under 12 years

    do not use this adult product in children under 12 years of age; this will provide more than the recommended dose (overdose) and may cause liver damage

    Members Mark Acetaminophen Other information

    • • store at 20º-25ºC (68º-77ºF)

    Inactive ingredients

    carnauba wax*, croscarmellose sodium*, hypromellose, polyethylene glycol, povidone, sodium metabisulfite*, sodium starch glycolate*, starch, stearic acid *may contain one or more of these ingredients

    Questions or comments?

    1-800-809-0469

    Principal Display Panel

    EXTRA STRENGTH

    Acetaminophen

    Pain Reliever/Fever Reducer

    Compare to Tylenol® active ingredient

    Contains no Aspirin

    Easy to Swallow

    Actual Size

    500 Caplets

    500 mg Each

    SEE NEW WARNINGS INFORMATION

    Members Mark Acetaminophen

    Acetaminophen TABLET

    Product Information

    Product Type Human otc drug label Item Code (Source) NDC:68196-484
    Route of Administration ORAL DEA Schedule

    Active Ingredient/Active Moiety

    Ingredient Name Basis of Strength Strength
    ACETAMINOPHEN ACETAMINOPHEN 500 mg

    Inactive Ingredients

    Ingredient Name Strength
    carnauba wax
    HYPROMELLOSES
    POLYETHYLENE GLYCOLS
    POVIDONES
    STEARIC ACID
    CROSCARMELLOSE SODIUM
    SODIUM METABISULFITE

    Product Characteristics

    Color Size Imprint Code Shape
    WHITE 16 mm L484 CAPSULE

    Packaging

    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NDC:68196-484-90 500 in 1 BOTTLE

    Marketing Information

    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    part part343 2010-02-08


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    Be sure to consult your doctor before taking any medication!
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