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331R Timely 49483-331 Aspirin 325mg Delayed Release Tablets


DRUG FACTS


OTC - ACTIVE INGREDIENT SECTION

Active ingredient (in each tablet) Aspirin 325 mg (NSAID*) *nonsteroidal anti-inflammatory drug


OTC - PURPOSE SECTION

Purpose Pain reliever


INDICATIONS & USAGE SECTION

Uses temporarily relieves minor aches and pains due to:

or as recommended by a doctor

  • headache
  • muscle pain
  • toothache
  • menstrual pain
  • colds
  • minor arthritis pain

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 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:

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

OTC - ASK DOCTOR/PHARMACIST SECTION

Ask a doctor or pharmacist before use if you are

  • taking a prescription drug for diabetes, gout, or arthritis

OTC - STOP USE SECTION

Stop use and ask a doctor if

feel faint have bloody or black stools vomit blood have stomach pain that does not get better

These could be signs of a serious condition.

  • an allergic reaction occurs. Seek medical help right away.
  • you experience any of the following signs of stomach bleeding:

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


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

SPL UNCLASSIFIED SECTION

Other information

  • each tablet contains: sodium 1 mg (VERY LOW SODIUM)
  • 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 and ethyl acrylate copolymer, microcrystalline cellulose, mineral oil, polysorbate 80, simethicone, sodium hydroxide, sodium lauryl sulfate, talc, titanium dioxide, triethyl citrate


OTC - QUESTIONS SECTION

Questions or comments? call 1-877-290-4008


HOW SUPPLIED

NDC: 71335-0157-1: 30 Tablets in a BOTTLE

NDC: 71335-0157-2: 60 Tablets in a BOTTLE

NDC: 71335-0157-3: 100 Tablets in a BOTTLE

NDC: 71335-0157-4: 90 Tablets in a BOTTLE

NDC: 71335-0157-5: 20 Tablets in a BOTTLE

NDC: 71335-0157-6: 45 Tablets in a BOTTLE

NDC: 71335-0157-7: 120 Tablets in a BOTTLE

NDC: 71335-0157-8: 7 Tablets in a BOTTLE


PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Aspirin E.C 325mg Tablet