Active ingredient(s)

Aspirin 81mg

Purpose

Pain Reliever

Use(s)

for the temporary relief of minor aches or as recommended by your doctor.

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.

Alergy Alert:

Aspirin may cause a severe allergic reaction which may include: Hives, facial swelling, asthma (wheezing), shock.

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 tomach bleeding.

Reye's Syndrome

if you are allergic to aspirin or any other pain reliever/fever reducer.

Ask a doctor before use if

you have asthma, ulcers, bleeding problems, stomach problems (such as heartburn, upset stomach or stomach pain) that persist or recure.

Ask a doctor or pharmacist before use if

you are taking a prescription drug for anticoagolation (blood thinning), gout, diabetes, or arthritis.

Stop use and ask a doctor if

-an allergic reaction occurs, Seel medical help right away.

-new symptoms occur

-pain gets worse or lasts more than 10 days.

-redness or swelling is present

-ringing in ears or loss of hearing occurs

Pregnancy/Breastfeeding

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

Keep out of reach of children.

In case of accidential 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 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

Tamper Evident: Do not use if imprinted safety seal under cap is broken or missing.

Use by expiration date on package.

Storage

Store at room temperature 15 degrees - 30 degrees C (59 degrees - 86 degrees F).

Inactive ingredients

Black Iron Oxide, Colloidal silicon dioxide, corn starch, D & C yellow # 10, FD&C yellow #6, hypromellose, microcrystalline cellulose, polydextrose, polyethylene glycol, polyvinyl acetate phthalate, propylene glycol, shellac wax, sodium alginate, sodium bicarbonate, stearic acid, titanium dioxide, triacetin, triethyl citrate.

Questions

Adverse drug event call: (800) 616-2471

distributed by Majpr Pharmaceuticals, 31778 Enterprise Drive, Livonia, MI 48150 USA

Principal Display Panel

Aspirin EC Tablets 81mg

ASPIRIN
aspirin tablet

Product Information
Product Type	HUMAN OTC DRUG	NDC Product Code (Source)	0615-3568 (0904-7704)
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
No Inactive Ingredients Found

Product Characteristics
Color	YELLOW	Score	no score
Shape	ROUND	Size	7mm
Flavor		Imprint Code	L
Contains

Packaging
#	NDC	Package Description	Multilevel Packaging
1	0615-3568-31	31 TABLET In 1 BLISTER PACK	None
2	0615-3568-39	30 TABLET In 1 BLISTER PACK	None

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC MONOGRAPH FINAL	part343	08/05/2010

Labeler - NCS HealthCare of KY, Inc dba Vangard Labs (050052943)

Establishment
Name	Address	ID/FEI	Operations
NCS HealthCare of KY, Inc dba Vangard Labs		050052943	RELABEL, REPACK

Revised: 08/2010NCS HealthCare of KY, Inc dba Vangard Labs