DrugCite

ASPIRIN  - aspirin tablet 
A&Z Pharmaceutical, Inc.

Aspirin

ACTIVE INGREDIENT (IN EACH TABLET)

Aspirin 325 mg (NSAID*)

*nonsteroidal anti-inflammatory drug

PURPOSE

Pain reliever/fever reducer

USES

provides temporary relief of ■ headache■ pain and fever of colds ■ muscle pain ■ menstrual pain ■ toothache ■ 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

Do not use

■ if you are allergic to aspirin or other pain relievers/fever reducer.

Ask a doctor before use if

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

Ask a doctor or pharmacist before use if you are

■ taking any other drug containing an NSAID (prescription or nonprescription) ■ taking a blood thinning (anticoagulant) or steroid drug ■ taking a prescription drug for diabetes, gout or arthritis

Stop use and ask a doctor if

■ 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 ■ an allergic reaction occurs. Seek medical help right away. ■ pain gets worse or lasts for more than 10 days ■ redness or swelling is present ■ fever gets worse or lasts more than 3 days ■ any new symptoms occur ■ ringing in the ears or loss of hearing occurs

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 specifically 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.

Directions

■ drink a full glass of water with each does ■ adults: 1 to 2 tablets with water. Dosage may be repeated every 4 hours, not to exceed 12 tablets in 24 hours. ■ children under 12: consult a doctor.

Other information

■ store at room temperature

Inactive ingredients

starch

DISPLAY PANEL

carton of Aspirin tablets


ASPIRIN 
aspirin  tablet
Product Information
Product Type HUMAN OTC DRUG NDC Product Code (Source) 62211-312
Route of Administration ORAL DEA Schedule     
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
ASPIRIN (ASPIRIN) ASPIRIN 325 mg
Inactive Ingredients
Ingredient Name Strength
STARCH, CORN  
Product Characteristics
Color white Score no score
Shape ROUND Size 11mm
Flavor Imprint Code A1
Contains     
Packaging
# NDC Package Description Multilevel Packaging
1 62211-312-01 50 TABLET In 1 PACKAGE None
2 62211-312-99 75000 TABLET In 1 CARTON None

Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
OTC monograph final part343 06/08/2007

Labeler - A&Z Pharmaceutical, Inc. (926820705)
Registrant - A&Z Pharmaceutical, Inc. (926820705)
Establishment
Name Address ID/FEI Operations
A&Z Pharmaceutical, Inc. 926820705 manufacture
Revised: 11/2010A&Z Pharmaceutical, Inc.