Medique Products Chewable Low Dose Aspirin 81 Mg

Medique Products Chewable Low Dose Aspirin 81 Mg
SPL v4
SPL
SPL Set ID 17009501-674d-c839-e063-6294a90a59fa
Route
ORAL
Published
Effective Date 2024-04-26
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Aspirin (81 mg)
Inactive Ingredients
Dextrates Saccharin Sodium Fd&c Yellow No. 6 Starch, Corn

Identifiers & Packaging

Pill Appearance
Imprint: AZ013 Shape: round Color: orange Size: 7 mm Score: 1
Marketing Status
OTC MONOGRAPH DRUG Active Since 2024-04-26

Description

Drug Facts

Purpose

Purpose Pain reliever


Medication Information

Purpose

Purpose

Pain reliever

Description

Drug Facts

Uses

Uses

for the temporary relief of minor aches and pains or as recommended by your doctor

Warnings

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 alcohol drinks every day while using this product

■ take more or for a longer time than directed

Directions

Directions

■ drink a full glass of water with each

Adults and children 12 years and over:

take 4 or 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 to 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
Drug Facts

Drug Facts

Active Ingredient

Active ingredient (in each tablet)

Aspirin 81 mg (NSAID)*

*nonsteroidal anti-inflammatory drug

Other Information

Other information

■ store at room temperature

■ tamper evident sealed packets

■ do not use any opened or torn packets

Inactive Ingredients

Inactive ingredients

corn starch, dextrates, FD&C yellow # 6 aluminum lake, orange flavor, saccharin sodium

Questions Or Comments?

Questions or comments? 1-800-634-7680

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

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

■ ringing in the ears or loss of hearing occurs

■ redness or swelling is present

■ new symptoms occur

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 specifically directed to do so by a doctor because if 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 accidental overdose, get medical help or contact a Poison Control Center (1-800-222-1222) right away.

Medique Chewable Low Dose Aspirin 81 Mg

Medique®

Chewable Low Dose

Aspirin

81 mg

Pain reliever (NSAID*)

*nonsteroidal anti-inflammatory drug

THIS PACKAGE IS FOR HOUSEHOLDS WITHOUT YOUNG CHILDREN.

**Talk to your doctor or other healthcare provider

before using this product for your heart.

Compare active ingredient to Bayer® Chewable Low Dose Aspirin

Registered Trademark Bayer Consumer

Tamper Evident Unit Dose Packets

24

Tablets

(24 x 1)

Ask A Doctor Or Pharmacist Before Use If You Are

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

■ gout

■ diabetes

■ arthritis


Structured Label Content

Uses

Uses

for the temporary relief of minor aches and pains or as recommended by your doctor

Purpose

Purpose

Pain reliever

Warnings

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 alcohol drinks every day while using this product

■ take more or for a longer time than directed

Directions

Directions

■ drink a full glass of water with each

Adults and children 12 years and over:

take 4 or 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 to 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
Drug Facts

Drug Facts

Active Ingredient (Active ingredient)

Active ingredient (in each tablet)

Aspirin 81 mg (NSAID)*

*nonsteroidal anti-inflammatory drug

Other Information (Other information)

Other information

■ store at room temperature

■ tamper evident sealed packets

■ do not use any opened or torn packets

Inactive Ingredients (Inactive ingredients)

Inactive ingredients

corn starch, dextrates, FD&C yellow # 6 aluminum lake, orange flavor, saccharin sodium

Questions Or Comments? (Questions or comments?)

Questions or comments? 1-800-634-7680

Ask A Doctor Before Use If (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

Stop Use and Ask A Doctor If (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

■ ringing in the ears or loss of hearing occurs

■ redness or swelling is present

■ new symptoms occur

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 specifically directed to do so by a doctor because if 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 accidental overdose, get medical help or contact a Poison Control Center (1-800-222-1222) right away.

Medique Chewable Low Dose Aspirin 81 Mg (Medique Chewable Low Dose Aspirin 81 mg)

Medique®

Chewable Low Dose

Aspirin

81 mg

Pain reliever (NSAID*)

*nonsteroidal anti-inflammatory drug

THIS PACKAGE IS FOR HOUSEHOLDS WITHOUT YOUNG CHILDREN.

**Talk to your doctor or other healthcare provider

before using this product for your heart.

Compare active ingredient to Bayer® Chewable Low Dose Aspirin

Registered Trademark Bayer Consumer

Tamper Evident Unit Dose Packets

24

Tablets

(24 x 1)

Ask A Doctor Or Pharmacist Before Use If You Are (Ask a doctor or pharmacist before use if you are)

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

■ gout

■ diabetes

■ arthritis


Advanced Ingredient Data


Raw Label Data

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