Aspirin 81mg Enteric Coated Tablets

Aspirin 81mg Enteric Coated Tablets
SPL v1
SPL
SPL Set ID 0adde1a9-1f82-7923-e063-6394a90a7f58
Route
ORAL
Published
Effective Date 2021-05-14
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Aspirin (81 mg)
Inactive Ingredients
Triacetin Stearic Acid Povidone Triethyl Citrate Sodium Lauryl Sulfate Microcrystalline Cellulose 102 Starch, Corn Silicon Dioxide Methacrylic Acid - Ethyl Acrylate Copolymer (1:2) Titanium Dioxide Sodium Bicarbonate Talc D&c Yellow No. 10 Hypromellose 2910 (6 Mpa.s)

Identifiers & Packaging

Pill Appearance
Imprint: S81 Shape: round Color: yellow Size: 8 mm Score: 1
Marketing Status
OTC MONOGRAPH DRUG Active Since 2021-05-03
Description

corn starch, pregelatinized starch, povidone. microcrystalline cellulose, colloidal silicon dioxide, stearic acid, methacrylic acid and ethyl acrylate copolymer, talc, titanium dioxide, triethyl citrate, sodium bicarbonate, sodium lauryl sulfate, d&c yellow #10 , hypromellose, triacetin

Medication Information

Warnings and Precautions

Reye's syndrome: Children and teenagers who have or are recoving 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 early sign of Reye's syndrome, a rare but serious illness.

Indications and Usage

Pin Reliever

Dosage and Administration

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

Description

corn starch, pregelatinized starch, povidone. microcrystalline cellulose, colloidal silicon dioxide, stearic acid, methacrylic acid and ethyl acrylate copolymer, talc, titanium dioxide, triethyl citrate, sodium bicarbonate, sodium lauryl sulfate, d&c yellow #10 , hypromellose, triacetin

Section 42229-5

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 steriod drug - take other drugs contiaining prescription or nonprescription NSAIDs (aspirin, ibuprofen, naprozen, or others) - have 3 or more alcoholic drinks every day while using this product - take more or for longer time than directed

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 50566-9

Stop use and ask a doctor if - an allergic reaction occurs. Seek medical help right away. - you are experierance any of the following signs of stomach bleeding: feel faint, have bloody or black stools, vomit blood, 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. these could be signs of a serious condition.

Section 50568-5

Ask a doctor or pharmacist before use if you are - taking a prescription drug for diabetes, gout, or arthritis - taking any other drug - under a doctor's care for any serious condition

Section 50569-3

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 you have not been drinking fluids you have lost a lot of fluid due to vomiting or diarrhea

Section 51727-6

corn starch, pregelatinized starch, povidone. microcrystalline cellulose, colloidal silicon dioxide, stearic acid, methacrylic acid and ethyl acrylate copolymer, talc, titanium dioxide, triethyl citrate, sodium bicarbonate, sodium lauryl sulfate, d&c yellow #10, hypromellose, triacetin

Section 51945-4

NDC 83813-001-01

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 becwause it may cause problems in the unborn child or complications during delivery.

Section 55105-1

Pain reliever

Section 55106-9

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

Section 60561-8

Allergy Alert: Aspirin may cause a severe allergic reaction which may include: - hives - facial swelling - shock - asthma (wheezing)

Aspirin Drug Facts

Do not use: if you are allergic to aspirin or any other pain reliver/fever reducer

Structured Label Content

Indications and Usage (34067-9)

Pin Reliever

Dosage and Administration (34068-7)

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

Warnings and Precautions (34071-1)

Reye's syndrome: Children and teenagers who have or are recoving 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 early sign of Reye's syndrome, a rare but serious illness.

Section 42229-5 (42229-5)

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 steriod drug - take other drugs contiaining prescription or nonprescription NSAIDs (aspirin, ibuprofen, naprozen, or others) - have 3 or more alcoholic drinks every day while using this product - take more or for longer time than directed

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 50566-9 (50566-9)

Stop use and ask a doctor if - an allergic reaction occurs. Seek medical help right away. - you are experierance any of the following signs of stomach bleeding: feel faint, have bloody or black stools, vomit blood, 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. these could be signs of a serious condition.

Section 50568-5 (50568-5)

Ask a doctor or pharmacist before use if you are - taking a prescription drug for diabetes, gout, or arthritis - taking any other drug - under a doctor's care for any serious condition

Section 50569-3 (50569-3)

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 you have not been drinking fluids you have lost a lot of fluid due to vomiting or diarrhea

Section 51727-6 (51727-6)

corn starch, pregelatinized starch, povidone. microcrystalline cellulose, colloidal silicon dioxide, stearic acid, methacrylic acid and ethyl acrylate copolymer, talc, titanium dioxide, triethyl citrate, sodium bicarbonate, sodium lauryl sulfate, d&c yellow #10, hypromellose, triacetin

Section 51945-4 (51945-4)

NDC 83813-001-01

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 becwause it may cause problems in the unborn child or complications during delivery.

Section 55105-1 (55105-1)

Pain reliever

Section 55106-9 (55106-9)

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

Section 60561-8 (60561-8)

Allergy Alert: Aspirin may cause a severe allergic reaction which may include: - hives - facial swelling - shock - asthma (wheezing)

Aspirin Drug Facts

Do not use: if you are allergic to aspirin or any other pain reliver/fever reducer

Advanced Ingredient Data

Raw Label Data

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Additional Information

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Source: dailymed · Ingested: 2026-02-15T12:02:23.649948 · Updated: 2026-03-14T23:01:55.379030