BAYER ASPIRIN- aspirin tablet

Bayer Aspirin by

Drug Labeling and Warnings

Bayer Aspirin by is a Otc medication manufactured, distributed, or labeled by Savings Distributors LLC. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Drug Facts

Active ingredient (in each tablet)

Aspirin 325 mg (NSAID)*

*nonsteroidal anti-inflammatory drug

Purpose

Pain reliever/fever reducer

Uses

temporarily relieves
headache muscle pain toothache

menstrual pain pain and fever of colds minor pain of arthritis

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 pain reliever/fever reducer

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 a 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

carnauba wax*,corn starch, hypromellose, powdered cellulose, triacetin

*may contain this ingredient

Questions or comments?

1-800-331-4536 (Mon – Fri 9AM – 5PM EST) or www.bayeraspirin.com

Package Labeling:

INGREDIENTS AND APPEARANCE

BAYER ASPIRIN 
aspirin tablet

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 73097-003(NDC:0280-2000)
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)
HYPROMELLOSE, UNSPECIFIED (UNII: 3NXW29V3WO)
POWDERED CELLULOSE (UNII: SMD1X3XO9M)
TRIACETIN (UNII: XHX3C3X673)

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

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 73097-003-50	25 in 1 CARTON	07/03/2019
1		2 in 1 POUCH; Type 0: Not a Combination Product
2	NDC: 73097-003-10	50 in 1 CARTON	07/03/2019
2		2 in 1 POUCH; Type 0: Not a Combination Product
3	NDC: 73097-003-02	1 in 1 CARTON	07/03/2019
3		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	07/03/2019

Labeler - Savings Distributors LLC (010527359)