BAYER ASPIRIN REGIMEN CHEWABLE LOW DOSE ASPIRIN ORANGE- aspirin tablet, chewable

Bayer Aspirin Regimen Chewable by

Drug Labeling and Warnings

Bayer Aspirin Regimen Chewable 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 ingredient (in each tablet)

Aspirin 81 mg (NSAID) 1

1 nonsteroidal anti-inflammatory drug

Purpose

Pain reliever

Uses

• for the temporary relief of minor aches and pains or as recommended by your doctor
• ask your doctor about other uses for Bayer 81 mg Orange Chewable 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
• this product for at least 7 days after tonsillectomy or oral surgery unless directed by a doctor
• if you have ever had an allergic reaction to this product or any of its ingredients

ASK DOCTOR/PHARMACIST

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
• 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

• 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

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

Inactive ingredients

colloidal silicon dioxide, corn starch, dextrose, FD&C yellow #6 aluminum lake, flavor, microcrystalline cellulose, saccharin sodium

QUESTIONS

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

36 count carton

INGREDIENTS AND APPEARANCE

BAYER ASPIRIN REGIMEN CHEWABLE  LOW DOSE ASPIRIN ORANGE
aspirin tablet, chewable

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 0280-2080
Route of Administration	ORAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
ASPIRIN (UNII: R16CO5Y76E) (ASPIRIN - UNII:R16CO5Y76E)	ASPIRIN	81 mg

Inactive Ingredients
Ingredient Name	Strength
ALUMINUM OXIDE (UNII: LMI26O6933)
FD&C YELLOW NO. 6 (UNII: H77VEI93A8)
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
STARCH, CORN (UNII: O8232NY3SJ)
DEXTROSE (UNII: IY9XDZ35W2)
CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)
SACCHARIN SODIUM (UNII: SB8ZUX40TY)

Product Characteristics
Color	orange	Score	no score
Shape	ROUND	Size	5mm
Flavor	ORANGE	Imprint Code	BAYER
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 0280-2080-18	1 in 1 CARTON	01/11/2015
1		18 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product
2	NDC: 0280-2080-36	1 in 1 CARTON	01/11/2015
2		36 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	01/11/2015

Labeler - Bayer HealthCare LLC. (112117283)