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HyVee Inc

Hy-Vee, Inc. Pain Relief Drug Facts


FULL PRESCRIBING INFORMATION: CONTENTS*




FULL PRESCRIBING INFORMATION

Active ingredient (in each geltab)

Acetaminophen 500 mg

Purpose

Pain reliever/fever reducer

pain relief 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. The maximum daily dose of this product is 6 geltabs (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

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 have ever had an allergic reaction to this product or any of its ingredients

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

  • •new symptoms occur
  • •redness or swelling is present
  • •pain gets worse or lasts for more than 10 days
  • •fever gets worse or lasts for more than 3 days

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 geltabs every 6 hours while symptoms last
  • do not take more than 6 geltabs in 24 hours, unless directed by a doctor
  • do not use for more than 10 days unless directed by a doctor

    adults and children 12 years and over

    children under 12 years

    ask a doctor

    pain relief Other information

    • •store at 20–25ºC (68-77ºF)

    Inactive ingredients

    corn starch*,croscarmellose sodium*, D&C yellow #10 aluminum lake, edetate disodium, edible ink, FD&C red #40 aluminum lake, gelatin, glycerin, hypromellose, polyethylene glycol, povidone, pregelatinized starch, purified water, sodium starch glycolate*, stearic acid, titanium dioxide *May contain one or more of these ingredients

    Questions or comments?

    1-800-719-9260

    Principal Display Panel

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    Compare to Extra Strength Tylenol® active ingredient

    PAIN RELIEF

    EXTRA STRENGTH

    Pain Reliever/Fever Reducer

    Acetaminophen

    Actual Size

    500 mg EACH

    pain relief

    Acetaminophen TABLET, COATED

    Product Information

    Product Type Human otc drug label Item Code (Source) NDC:42507-187
    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
    STARCH, CORN
    CROSCARMELLOSE SODIUM
    D&C YELLOW NO. 10
    EDETATE DISODIUM
    FD&C RED NO. 40
    GELATIN
    GLYCERIN
    HYPROMELLOSES
    POLYETHYLENE GLYCOLS
    POVIDONES
    water
    STEARIC ACID
    titanium dioxide

    Product Characteristics

    Color Size Imprint Code Shape
    RED 10 mm L187 ROUND

    Packaging

    # Item Code Package Description Marketing Start Date Marketing End Date
    1 50 in 1 BOTTLE
    2 100 in 1 BOTTLE
    3 NDC:42507-187-78 1 in 1 CARTON

    Marketing Information

    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    part part343 1995-11-09


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    Be sure to consult your doctor before taking any medication!
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