Bayer Chewable - Aspirin Regimen

Bayer Chewable - Aspirin Regimen
SPL v5
SPL
SPL Set ID 070d5713-e018-2913-e054-00144ff8d46c
Route
ORAL
Published
Effective Date 2017-09-19
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Aspirin (81 mg)
Inactive Ingredients
Silicon Dioxide Starch, Corn Aluminum Oxide D&c Red No. 27 Dextrose Fd&c Red No. 40 Cellulose, Microcrystalline

Identifiers & Packaging

Pill Appearance
Imprint: BAYER Shape: round Color: pink Size: 5 mm Score: 1
Marketing Status
OTC MONOGRAPH DRUG Active Since 2002-07-02

Description

Drug Facts

Purpose

Pain reliever


Medication Information

Purpose

Pain reliever

Description

Drug Facts

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 Cherry Chewable Aspirin

Section 42229-5

Drug Facts

Section 55106-9

Aspirin 81 mg (NSAID)

nonsteroidal anti-inflammatory drug

Stop Use

● 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

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

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

Do Not Use

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

36 Count Carton

Other Information

Other information

● save carton for full directions and warnings

● store at room temperature

Inactive Ingredients

Inactive ingredients colloidal silicon dioxide, corn starch, D&C red #27 aluminum lake, dextrose, FD&C red #40 aluminum lake, flavor, microcrystalline cellulose, saccharin sodium

Questions Or Comments

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

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

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

● gout ● diabetes ● arthritis

If Pregnant 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.


Structured Label Content

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 Cherry Chewable Aspirin

Section 42229-5 (42229-5)

Drug Facts

Section 55106-9 (55106-9)

Aspirin 81 mg (NSAID)

nonsteroidal anti-inflammatory drug

Purpose

Pain reliever

Stop Use (Stop use)

● 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

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

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

Do Not Use (Do not use)

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

36 Count Carton (36 count carton)

Other Information (Other information)

Other information

● save carton for full directions and warnings

● store at room temperature

Inactive Ingredients (Inactive ingredients)

Inactive ingredients colloidal silicon dioxide, corn starch, D&C red #27 aluminum lake, dextrose, FD&C red #40 aluminum lake, flavor, microcrystalline cellulose, saccharin sodium

Questions Or Comments (Questions or comments)

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

Ask A Doctor Before Use If (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 (Ask a doctor or pharmacist)

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

● gout ● diabetes ● arthritis

If Pregnant Or Breast Feeding (If pregnant 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)

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


Advanced Ingredient Data


Raw Label Data

All Sections (JSON)