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DRUG FACTS


OTC - ACTIVE INGREDIENT SECTION

Active ingredient (in each tablet)                  Purpose

Aspirin 325 mg (NSAID*).............................Pain reliever

*nonsteroidal anti-inflammatory drug


OTC - PURPOSE SECTION

PurposePain reliever


INDICATIONS & USAGE SECTION

Uses

  • •for the temporary relief of minor aches and pains due to•headache•colds•muscle pain•menstrual pain•toothache•minor pain of arthritis
  • •or as directed by your doctor

WARNINGS SECTION

WarningsReye'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 or 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 inclue:

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

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

OTC - DO NOT USE SECTION

Do not use

  • •if you are allergic to aspirin or any other pain reliever/fever reducer

OTC - ASK DOCTOR SECTION

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
  • •you have not been drinking fluids

OTC - ASK DOCTOR/PHARMACIST SECTION

Ask a doctor or pharmacist before use if you are

  • •taking a prescription drug for diabetes, gout, or arthritis
  • •taking any other drugs
  • •under a doctor's care for any serious condition

OTC - STOP USE SECTION

Stop use and ask a doctor if

  • •you experience any of the following signs of stomach bleeding:•feel faint•have bloody or black stools•vomit blood•have stomach pain that does not get better
  • •pain gets worse or lasts more than 10 days
  • •fever gets worse or lasts more than 3 days
  • •redness or swelling is present in the painful area
  • •any new symptoms appear
  • •ringing in the ears or a loss of hearing occurs

OTC - PREGNANCY OR BREAST FEEDING SECTION

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.


OTC - KEEP OUT OF REACH OF CHILDREN SECTION

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).


DOSAGE & ADMINISTRATION SECTION

Directions

  • •drink a full glass of water with each dose
  • •adults and children 12 years and over: take 1 to 2 tablets every 4 hours while symptoms last. Do not take more than 12 tablets in 24 hours unless directed by a doctor
  • •children under 12 years: consult a doctor

STORAGE AND HANDLING SECTION

Other information

  • •store at 25°C (77°F) excursions permitted between 15°-30°C (59°-86°F)
  • •use by expiration date on package

INACTIVE INGREDIENT SECTION

Inactive ingredients corn starch, croscarmellose sodium, D-C yellow #10 aluminum lake, FD-C yellow #6 aluminum lake, hypromellose, methacrylic acid copolymer, microcrystalline cellulose, mineral oil, polysorbate 80, simethicone, sodium hydroxide, sodium lauryl sulfate, talc, titanium dioxide, triethyl citrate


OTC - QUESTIONS SECTION

Questions? To Report Adverse Drug Event Call: (800) 616-2471


PACKAGE LABEL.PRINCIPAL DISPLAY PANEL