DrugCite

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

Aspirin (enteric coated orange)

ACTIVE INGREDIENT (IN EACH TABLET)

Aspirin 325 mg (NSAID*)

*nonsteroidal anti-inflammatory drug

PURPOSE

Pain reliever

USES

■ temporary relief of minor aches and pains or as recommended by your doctor.

WARNINGS

Reye’s syndrome: Children and teenagers should not use this medicine for chicken pox or flu symptoms before a doctor is consulted about Reye’s syndrome, a rare but serious illness reported to be associated with aspirin.

Alcohol Warning: ■ If you consume 3 or more alcoholic drinks every day, ask your doctor whether you should take aspirin or other pain relievers/fever reducers. Aspirin may cause stomach bleeding.

Do not use

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

Ask a doctor before use if you have

asthma ■ stomach problems (such as heartburn, upset stomach or stomach pain) that persist or recur ■ ulcers ■ bleeding problems

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

■ an allergic reaction occurs. Seek medical help right away ■ 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

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 dose ■ adults and children 12 years and over: take 1 to 2 tablets every 4 hours not to exceed 12 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

Acetylated monoglycerides, corn starch, croscarmellose sodium, D&C Yellow 10, FD&C Yellow #6, hypromellose, hypromellose phthalate, microcrystalline cellulose, mineral oil, polyethylene glycol 400, polysorbate 80, titanium dioxide

DISPLAY PANEL

Aspirin Enteirc Coated


ASPIRIN 
aspirin  tablet, coated
Product Information
Product Type HUMAN OTC DRUG NDC Product Code (Source) 62211-225
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
HYPROMELLOSE PHTHALATE (31% PHTHALATE, 40 CST)  
MINERAL OIL  
D&C YELLOW NO. 10  
FD&C YELLOW NO. 6  
CROSCARMELLOSE SODIUM  
POLYETHYLENE GLYCOL 400  
CELLULOSE, MICROCRYSTALLINE  
POLYSORBATE 80  
TITANIUM DIOXIDE  
HYPROMELLOSES  
Product Characteristics
Color yellow Score no score
Shape ROUND Size 8mm
Flavor Imprint Code A
Contains     
Packaging
# NDC Package Description Multilevel Packaging
1 62211-225-40 40 TABLET In 1 PACKAGE None
2 62211-225-99 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: 02/2011A&Z Pharmaceutical, Inc.