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

Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

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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
aspirin tablet, coated

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:62211-225
Route of Administration	ORAL	DEA Schedule

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
ASPIRIN (UNII: R16CO5Y76E) (ASPIRIN - UNII:R16CO5Y76E)	ASPIRIN	325 mg

Ingredient Name	Strength
Inactive Ingredients
HYPROMELLOSE PHTHALATE (31% PHTHALATE, 40 CST) (UNII: G4U024CQK6)
MINERAL OIL (UNII: T5L8T28FGP)
D&C YELLOW NO. 10 (UNII: 35SW5USQ3G)
FD&C YELLOW NO. 6 (UNII: H77VEI93A8)
CROSCARMELLOSE SODIUM (UNII: M28OL1HH48)
POLYETHYLENE GLYCOL 400 (UNII: B697894SGQ)
CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)
POLYSORBATE 80 (UNII: 6OZP39ZG8H)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)
HYPROMELLOSES (UNII: 3NXW29V3WO)

Product Characteristics
Color	yellow	Score	no score
Shape	ROUND	Size	8mm
Flavor		Imprint Code	A
Contains

#	Item Code	Package Description
Packaging
1	NDC:62211-225-40	40 in 1 PACKAGE; Type 0: Not a Combination Product
2	NDC:62211-225-99	75000 in 1 CARTON; Type 0: Not a Combination Product

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph final	part343	11/03/2009	05/11/2015

Labeler - A&Z Pharmaceutical, Inc. (926820705)

Registrant - A&Z Pharmaceutical, Inc. (926820705)

Name	Address	ID/FEI	Business Operations
Establishment
A&Z Pharmaceutical, Inc.		926820705	manufacture(62211-225)

Revised: 5/2015

Document Id: a54f67ec-dfc4-49a7-b013-38727c1a290f

Set id: 67f8afe8-ba6e-4ff2-8e5b-3910fce424d4

Version: 2

Effective Time: 20150511

A&Z Pharmaceutical, Inc.