BAYER GENUINE ASPIRIN- aspirin tablet, coated

Bayer Genuine Aspirin by

Drug Labeling and Warnings

Bayer Genuine Aspirin by is a Otc medication manufactured, distributed, or labeled by Unifirst First Aid Corporation. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

SPL UNCLASSIFIED SECTION

Drug Facts

Active ingredient (in each tablet)

Aspirin 325 mg (NSAID)*

*nonsteroidal anti-inflammatory drug

Purpose

Pain reliever/fever reducer

Uses

• temporarily relieves minor aches and pains due to:
• headache
• muscle pain
• toothache
• menstrual pain
• colds
• minor pain of arthritis
• temporarily reduces fever

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 any other any other pain reliever/ fever reducer
• if you have ever had an allergic reaction to this product or any of its ingredients

Ask a doctor before use if

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

Ask a doctor or pharmacist before use if you are

taking a prescription drug for

• gout
• diabetes
• arthritis

Stop use and ask a doctor if

• an allergic reaction occurs. Seek medical help right away.
• 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
• pain gets worse or lasts more than 10 days
• redness or swelling is present
• fever lasts more than 3 days
• 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 definitely 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 dose
• adults and children 12 years and over: take 1 or 2 tablets every 4 hours or 3 tablets every 6 hours, not to exceed 12 tablets in 24 hours.
• Children under 12 years: consult a doctor

Other information

• save carton for full directions and warnings
• store at room temperature

Inactive ingredients

corn starch, hypromellose, powdered cellulose, triacetin

Questions or comments?

1-800-331-4536

Bayer Aspirin Label

Genuine Aspirin

Bayer ®

Aspirin (NSAID) Pain Reliever/Fever Reducer

The Wonder Drug ®

325 mg

Safe Pain Relief Plus

Lifesaving Benefits

50

Coated Tablets

To Open,

Push in Tab and Pull Out

50 Pouches of 2 Tablets Each

INGREDIENTS AND APPEARANCE

BAYER GENUINE ASPIRIN 
aspirin tablet, coated

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 47682-456
Route of Administration	ORAL

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

Inactive Ingredients
Ingredient Name	Strength
CARNAUBA WAX (UNII: R12CBM0EIZ)
STARCH, CORN (UNII: O8232NY3SJ)
HYPROMELLOSES (UNII: 3NXW29V3WO)
POWDERED CELLULOSE (UNII: SMD1X3XO9M)
TRIACETIN (UNII: XHX3C3X673)

Product Characteristics
Color	white (white)	Score	no score
Shape	ROUND (ROUND)	Size	10mm
Flavor		Imprint Code	BAYER;BAYER
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 47682-456-50	25 in 1 BOX	01/24/2014
1		2 in 1 POUCH; Type 0: Not a Combination Product
2	NDC: 47682-456-47	100 in 1 BOX	01/24/2014
2		2 in 1 POUCH; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part343	01/24/2014

Labeler - Unifirst First Aid Corporation (832947092)

Registrant - Unifirst First Aid Corporation (832947092)

Establishment
Name	Address	ID/FEI	Business Operations
Bayer Healthcare LLC		072827066	manufacture(47682-456)