DrugCite

ASPIRIN  - aspirin tablet, coated 
A&Z Pharmaceutical, Inc.

Aspirin (enteric coated yellow)

ACTIVE INGREDIENT (IN EACH TABLET)

Aspirin 81 mg (NSAID*)

*nonsteroidal anti-inflammatory drug

PURPOSE

Pain reliever

USES

■ relief of minor aches and pains or as recommended by your doctor. Because of its delayed action, this product will not provide fast relief of headaches or other symptoms needing immediate relief

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 reducers

Ask a doctor before use if

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

Ask a doctor or pharmacist before use if you are

taking a prescription drug for ■ anticoagulation (thinning the blood) ■ diabetes ■ gout ■ arthritis

Stop use and ask a doctor if

■ you experience any of the following signs of stomach bleeding: feel faint, vomits blood, have bloody or black stools, have stomach pain that does not get better ■ new symptoms occur ■ redness or swelling is present ■ ringing in the ears or loss of hearing occurs ■ pain gets worse or lasts for more than 10 days ■ fever gets worse or lasts for more than 3 days ■ you may report side effects to 1-888-952-0050

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 accidental overdose, contact a doctor or Poison Control Center immediately.

Directions

■ drink a full glass of water with each does ■ adults and children 12 years and over: take 4 to 8 tablets every 4 hours not to exceed 48 tablets in 24 hours unless directed by a doctor ■ Children under 12 years: consult a doctor

Other information

■ save carton for full directions and warnings ■ store at room temperature ■ do not use if imprinted safety seal under cap is broken or missing

Inactive ingredients

Anhydrous lactose, carnauba wax, colloidal silicon dioxide, croscarmellose sodium, D&C Yellow 10, methacrylic acid copolymer, microcrystalline cellulose, polysorbate 80, sodium hydroxide, sodium lauryl sulfate, titanium dioxide, triethyl citrate

DISPLAY PANEL

Aspirin Enteirc Coated


ASPIRIN 
aspirin  tablet, coated
Product Information
Product Type HUMAN OTC DRUG NDC Product Code (Source) 62211-220
Route of Administration ORAL DEA Schedule     
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
ASPIRIN (ASPIRIN) ASPIRIN 81 mg
Inactive Ingredients
Ingredient Name Strength
CARNAUBA WAX  
SODIUM LAURYL SULFATE  
COLLOIDAL SILICON DIOXIDE  
SODIUM HYDROXIDE  
D&C YELLOW NO. 10  
ANHYDROUS LACTOSE  
CROSCARMELLOSE SODIUM  
METHACRYLIC ACID  
CELLULOSE, MICROCRYSTALLINE  
POLYSORBATE 80  
TITANIUM DIOXIDE  
TRIETHYL CITRATE  
DIMETHICONE  
SILICON DIOXIDE  
Product Characteristics
Color yellow Score no score
Shape ROUND Size 8mm
Flavor Imprint Code A
Contains     
Packaging
# NDC Package Description Multilevel Packaging
1 62211-220-50 50 TABLET In 1 PACKAGE None
2 62211-220-99 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 11/03/2009

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.