Bayer Chewable Aspirin 81mg -orange

Bayer Chewable Aspirin 81mg -orange
SPL v6
SPL
SPL Set ID 0c6ae05f-760f-34d1-e054-00144ff88e88
Route
ORAL
Published
Effective Date 2015-01-11
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Aspirin (81 mg)
Inactive Ingredients
Aluminum Oxide Fd&c Yellow No. 6 Silicon Dioxide Starch, Corn Dextrose Cellulose, Microcrystalline Saccharin Sodium

Identifiers & Packaging

Pill Appearance
Imprint: BAYER Shape: round Color: orange Size: 5 mm Score: 1
Marketing Status
OTC MONOGRAPH DRUG Active Since 2015-01-11

Description

Aspirin 81 mg (NSAID) nonsteroidal anti-inflammatory drug

Purpose

Pain reliever


Medication Information

Purpose

Pain reliever

Description

Aspirin 81 mg (NSAID) nonsteroidal anti-inflammatory drug

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
Section 50565-1

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

Section 50568-5

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

  • gout
  • diabetes
  • arthritis
Section 53413-1

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

Section 53414-9

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.

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
  • 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
  • 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

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
Active Ingredient (in Each Tablet)

Aspirin 81 mg (NSAID)

nonsteroidal anti-inflammatory drug


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 Orange Chewable Aspirin
Section 50565-1 (50565-1)

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

Section 50568-5 (50568-5)

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

  • gout
  • diabetes
  • arthritis
Section 53413-1 (53413-1)

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

Section 53414-9 (53414-9)

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.

Purpose

Pain reliever

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 (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, dextrose, FD&C yellow #6 aluminum lake, flavor, microcrystalline cellulose, saccharin sodium

Stop Use and Ask A Doctor If (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
Active Ingredient (in Each Tablet) (Active ingredient (in each tablet))

Aspirin 81 mg (NSAID)

nonsteroidal anti-inflammatory drug


Advanced Ingredient Data


Raw Label Data

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