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smart health aspirin

L Perrigo Company

Perrigo Aspirin Drug Facts


FULL PRESCRIBING INFORMATION: CONTENTS*




FULL PRESCRIBING INFORMATION

Active ingredient (in each tablet)

Aspirin 325 mg (NSAID)*

*nonsteroidal anti-inflammatory drug

Purpose

Pain reliever/fever reducer

smart health aspirin Uses

  • temporarily relieves minor aches and pains due to:
  • muscular aches
  • the common cold
  • headache
  • minor pain of arthritis
  • premenstrual and menstrual cramps
  • toothache
  • temporarily reduces fever

Warnings

Reye’s syndrome: Children and teenagers who have or are recovering from chicken pox or flu-like symptoms should not use this product. When using this product, if changes in behavior with nausea and vomiting occur, consult a doctor because these symptoms could be an early sign of Reye’s Syndrome, a rare but serious illness.

Allergy alert: Aspirin may cause a severe allergic reaction which may include:

  • hives
  • facial swelling
  • asthma (wheezing)
  • shock

Stomach bleeding warning

This product contains an NSAID, which may cause severe stomach bleeding. The chance is higher if you

  • are age 60 or older
  • have had stomach ulcers or bleeding problems
  • take a blood thinning (anticoagulant) or steroid drug
  • take other drugs containing prescription or nonprescription NSAIDs (aspirin, ibuprofen, naproxen, or others)
  • have 3 or more alcoholic drinks every day while using this product
  • take more or for a longer time than directed

Do not use

  • if you have ever had an allergic reaction to any other pain reliever/fever reducer

Ask a doctor before use if

  • stomach bleeding warning applies to you
  • you have a history of stomach problems, such as heartburn
  • you have high blood pressure, heart disease, liver cirrhosis, or kidney disease
  • you are taking a diuretic
  • you have asthma

Ask a doctor or pharmacist before use if you are

taking a prescription drug for:

  • diabetes
  • gout
  • arthritis

Stop use and ask a doctor if

  • an allergic reaction occurs. Seek medical help right away.
  • you experience any of the following signs of stomach bleeding:
  • feel faint
  • vomit blood
  • have bloody or black stools
  • have stomach pain that does not get better
  • fever gets worse or lasts for more than 3 days
  • pain gets worse or lasts for more than 10 days
  • ringing in the ears or a loss of hearing occurs
  • redness or swelling is present
  • new symptoms occur

If pregnant or breast-feeding,

ask a health professional before use. It is especially important not to use aspirin during the last 3 months of pregnancy unless definitely directed to do so by a doctor because it may cause problems in the unborn child or complications during delivery.

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)

Directions

  • drink a full glass of water with each dose
  • adults and children 12 years and over: take 1 or 2 tablets every 4 hours, or 3 tablets every 6 hours; do not exceed 12 tablets in 24 hours
  • children under 12 years: ask a doctor

Inactive ingredients

dibasic calcium phosphate, starch

Questions or comments?

1-800-719-9260

Principal Display Panel

Aspirin

Regular Strength

Pain Reliever/Fever Reducer (NSAID)

Fast, Safe Pain Relief

Caffeine Free and Very Low Sodium

See New Warnings Information

325 mg

smart health aspirin
Aspirin Regular Strength Label Image 1 Aspirin Regular Strength Label Image 2 Aspirin Regular Strength Label Image 3

smart health aspirin

Aspirin TABLET

Product Information

Product Type Human otc drug label Item Code (Source) NDC:0113-1411
Route of Administration ORAL DEA Schedule

Active Ingredient/Active Moiety

Ingredient Name Basis of Strength Strength
aspirin ASPIRIN 325 mg

Inactive Ingredients

Ingredient Name Strength
ANHYDROUS DIBASIC CALCIUM PHOSPHATE

Product Characteristics

Color Size Imprint Code Shape
WHITE 11 mm Aspirin;L ROUND

Packaging

# Item Code Package Description Marketing Start Date Marketing End Date
1 NDC:0113-1411-82 200 in 1 BOTTLE

Marketing Information

Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
part part343 2003-04-09


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Be sure to consult your doctor before taking any medication!
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