Aspirin tablet

Spl unclassified section

Drug Facts

Active ingredient (in each tablet)

Aspirin 325 mg (NSAID)

Purposes

Pain reliever/fever reducer

Uses

temporarily relieves

  • headache
  • muscle pain
  • toothache
  • menstrual pain
  • pain and fever of colds
  • minor pain of arthritis

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

Otc - do not use section

Do not useif you are allergic to aspirin or 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

Otc - ask doctor/pharmacist section

Ask a doctor or pharmacist before use if you aretaking a prescription drug for

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

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, not to exceed 12 tablets in 24 hours
  • children under 12 years: consult a doctor

Other information

  • save carton for full directions and warnings
  • store at room temperature

Inactive ingredients

carnauba wax, corn starch, hypromellose, powdered cellulose, triacetin

Ingredients and appearance - Product information

Aspirin tablet- Aspirin

Product information

Product Type HUMAN OTC DRUG LABEL Item Code (Source) NDC: 76413-303
Route of Administration Oral

Active Ingredient/Active Moiety

Ingredient Name Strength
Aspirin ( UNII: R16CO5Y76E)( Aspirin - UNII: R16CO5Y76E ) 325 mgin 1

Inactive Ingredients

Ingredient Name Code
Carnauba wax ( UNII: R12CBM0EIZ)
Starch, corn ( UNII: O8232NY3SJ)
Hypromelloses ( UNII: 3NXW29V3WO)
Powdered cellulose ( UNII: SMD1X3XO9M)
Triacetin ( UNII: XHX3C3X673)

Product Characteristics

Color WHITE Score 1
Shape ROUND Size 10 mm
Imprint Code BAYER

Marketing Information

Marketing Category Application Number or Monograph Citation Territorial Authority Marketing Start Date
OTC MONOGRAPH NOT FINAL part343 USA

Labeler - Central Texas Community Health Centers( 079674019)

Establishment

Name ID/FEI Business Operations
Central Texas Community Health Centers 079674019 REPACK( 76413-303), RELABEL( 76413-303)

Principal display panel - 325 mg tablet bottle carton

CommUnityCare Federally Qualified Health Centers

ASPIRIN
325 MG #
24
TABLETS

Date:

Name:
Dr.

TAKE AS DIRECTED.

123456

1/1/01

ASPIRIN 325 MG #24 TABS NDC 76413-303-24

Batch: 123456
Lot: 123456
Exp: 1/1/01
BAYER

Federal law prohibits the transfer of this drug to any other person than the patient for whom prescribed.

nonsteroidal anti-inflammatory drug
may contain this ingredient