BAYER WOMENS- aspirin tablet, coated

Bayer Womens by

Drug Labeling and Warnings

Bayer Womens by is a Otc medication manufactured, distributed, or labeled by Bayer HealthCare LLC.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Drug Facts

Active ingredients

* nonsteroidal anti-inflammatory drug
Active ingredients (in each caplet)	Purposes
Aspirin 81 mg (NSAID) *	Pain reliever
Calcium carbonate 777 mg	Buffer

Purposes

Uses

• for the temporary relief of minor aches and pains or as recommended by your doctor.
• ask your doctor about other uses for Bayer Women’s 81 mg Aspirin

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
• 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 DOCTOR/PHARMACIST

Ask a doctor or pharmacist before use if you are taking a prescription

drug for

• gout
• diabetes
• arthritis

STOP USE

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
• new symptoms occur
• ringing in the ears or a loss of hearing occurs

PREGNANCY OR BREAST FEEDING

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

Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center right away.

Directions

• talk to your doctor about regimen use of aspirin
• drink a full glass of water with each dose
• adults and children 12 years and over: take 4 to 8 caplets every 4 hours not to exceed 10 caplets in 24 hours unless directed by a doctor
• children under 12 years: consult a doctor

Other information

• each caplet contains: calcium 300 mg, sodium 1 mg
• contains lactose (milk)
• store at room temperature. Avoid excessive heat above 40°C (104°F).
• save carton for full directions and warnings

Inactive ingredients

carnauba wax, colloidal silicon dioxide, hypromellose, lactose monohydrate, maltodextrin, microcrystalline cellulose, polydextrose, powdered cellulose, pregelatinized starch, sodium starch glycolate, titanium dioxide, triacetin, zinc stearate

QUESTIONS

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

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

BAYER WOMENS 
aspirin tablet, coated

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 0280-2200
Route of Administration	ORAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
ASPIRIN (UNII: R16CO5Y76E) (ASPIRIN - UNII:R16CO5Y76E)	ASPIRIN	81 mg
CALCIUM CARBONATE (UNII: H0G9379FGK) (CALCIUM CATION - UNII:2M83C4R6ZB)	CALCIUM CATION	777 mg

Inactive Ingredients
Ingredient Name	Strength
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
HYPROMELLOSES (UNII: 3NXW29V3WO)
LACTOSE MONOHYDRATE (UNII: EWQ57Q8I5X)
MALTODEXTRIN (UNII: 7CVR7L4A2D)
POLYDEXTROSE (UNII: VH2XOU12IE)
TRIACETIN (UNII: XHX3C3X673)
ZINC STEARATE (UNII: H92E6QA4FV)
CARNAUBA WAX (UNII: R12CBM0EIZ)
CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)
POWDERED CELLULOSE (UNII: SMD1X3XO9M)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)

Product Characteristics
Color	white	Score	no score
Shape	OVAL	Size	17mm
Flavor		Imprint Code	BAYER
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 0280-2200-60	1 in 1 CARTON	01/09/2015
1		60 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part343	01/09/2015

Labeler - Bayer HealthCare LLC. (112117283)