Enteric Coated Aspirin

Enteric Coated Aspirin
SPL v4
SPL
SPL Set ID a7c02378-4213-4e57-aca2-2437ad02f786
Route
ORAL
Published
Effective Date 2020-01-16
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Aspirin (81 mg)
Inactive Ingredients
Starch, Corn D&c Yellow No. 10 Fd&c Yellow No. 6 Hypromellose, Unspecified Methacrylic Acid Microcrystalline Cellulose Polydextrose Polyethylene Glycol, Unspecified Silicon Dioxide Sodium Bicarbonate Sodium Lauryl Sulfate Talc Titanium Dioxide Triacetin Triethyl Citrate

Identifiers & Packaging

Pill Appearance
Imprint: L Shape: round Color: yellow Size: 7 mm Score: 1
Marketing Status
OTC MONOGRAPH DRUG Active Since 2020-01-16

Description

Aspirin 81mg (NSAID)**  **nonsteroidal anti-inflammatory drug

Purpose

Pain reliever


Medication Information

Purpose

Pain reliever

Description

Aspirin 81mg (NSAID)**  **nonsteroidal anti-inflammatory drug

Uses

for the temporary relief of minor aches and pains or as recommended by your doctor. Because of its delayed action, this product will not provide fast relief of headaches or other symptoms needing immediate relief.

Warnings

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. 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 Reye’s syndrome: Allergy alert:

Directions

• drink a full glass of water with each dose •  take 4 to 8 tablets every 4 hours, not to exceed 48 tablets in 24 hours unless directed by a doctor •  consult a doctor adults and children 12 years  and over: children under 12 years:

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 or product or any of its ingredients

Questions?

call toll-free 1-800-935-6737

Other Information

• store at 25°C (77°F); excursions permitted between 15°- 30°C (59°-86°F)

Inactive Ingredients

corn starch, D&C Yellow # 10, FD&C Yellow # 6, hypromellose, methacrylic acid, microcrystalline cellulose, polydextrose, polyethylene glycol, shellac wax, silica, simethicone, sodium bicarbonate, sodium lauryl sulfate, talc, titanium dioxide, triacetin, triethyl citrate. 

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

• 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 • fever gets worse or lasts more than 3 days • redness or swelling is present • new symptoms occur • ringing in the ears or a loss of hearing occurs

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.

In case of overdose, get medical help or contact a Poison Control Center (1-800-222-1222) right away.

Package Labeling: 54257 274 06

Package Labeling: 54257 274 25

Active Ingredient (in Each Tablet)

Aspirin 81mg (NSAID)** 

**nonsteroidal anti-inflammatory drug

Ask A Doctor Or Pharmacist Before Use If You are

taking a prescription drug for • gout • diabetes • arthritis


Structured Label Content

Uses

for the temporary relief of minor aches and pains or as recommended by your doctor. Because of its delayed action, this product will not provide fast relief of headaches or other symptoms needing immediate relief.

Purpose

Pain reliever

Warnings

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. 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 Reye’s syndrome: Allergy alert:

Directions

• drink a full glass of water with each dose •  take 4 to 8 tablets every 4 hours, not to exceed 48 tablets in 24 hours unless directed by a doctor •  consult a doctor adults and children 12 years  and over: children under 12 years:

Do Not Use (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 or product or any of its ingredients

Questions?

call toll-free 1-800-935-6737

Other Information (Other information)

• store at 25°C (77°F); excursions permitted between 15°- 30°C (59°-86°F)

Inactive Ingredients (Inactive ingredients)

corn starch, D&C Yellow # 10, FD&C Yellow # 6, hypromellose, methacrylic acid, microcrystalline cellulose, polydextrose, polyethylene glycol, shellac wax, silica, simethicone, sodium bicarbonate, sodium lauryl sulfate, talc, titanium dioxide, triacetin, triethyl citrate. 

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 • fever gets worse or lasts more than 3 days • redness or swelling is present • new symptoms occur • ringing in the ears or a loss of hearing occurs

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 (1-800-222-1222) right away.

Package Labeling: 54257 274 06 (Package Labeling: 54257-274-06)

Package Labeling: 54257 274 25 (Package Labeling: 54257-274-25)

Active Ingredient (in Each Tablet) (Active ingredient (in each tablet))

Aspirin 81mg (NSAID)** 

**nonsteroidal anti-inflammatory drug

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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