Aspirin 81mg Ec

Aspirin 81mg Ec
SPL v8
SPL
SPL Set ID b247fe39-7f65-e502-e053-2a95a90a08f1
Route
ORAL
Published
Effective Date 2020-10-01
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Aspirin (81 mg)
Inactive Ingredients
D&c Yellow No. 10 Silicon Dioxide Methacrylic Acid And Ethyl Acrylate Copolymer Talc Titanium Dioxide Triethyl Citrate Sodium Bicarbonate Sodium Lauryl Sulfate Povidone Microcrystalline Cellulose Stearic Acid Starch, Corn Hypromellose, Unspecified Triacetin

Identifiers & Packaging

Pill Appearance
Imprint: 17;S Shape: round Color: yellow Size: 5 mm Score: 1
Marketing Status
OTC MONOGRAPH DRUG Active Since 2020-10-01

Description

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

Purpose

Pain reliever


Medication Information

Purpose

Pain reliever

Description

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

Uses

temporarily relieves minor aches and pains

Because of its delayed action, this product will not prodice fast relief of headaches or other symptoms needing immediate relief.

ask your doctor about other uses for enteric-coated 81 mg Aspirin

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 50570-1

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

Section 51945-4

NDC 69168-066-02

Reliable-1

Adult Low Strength

Pain Reliever

Aspirin USP 81 mg (NSAID)

Enteric Coated

120 tablets

Compare to Active Ingredient in Aspirin Regimen BAYER®

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 60561-8

Allergy Alert: Aspirin may cause a severe allergic reaction which may include:

- hives

- facial swelling

- shock

- asthma (wheezing)

Warnings

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.

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

Other Information

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

- Use by expiration date on package

Inactive Ingredients

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

Active Ingredient (in Each Tablet)

Aspirin 81 mg (NSAID*)

*nonsteroidal anti-inflamatory drug


Structured Label Content

Uses

temporarily relieves minor aches and pains

Because of its delayed action, this product will not prodice fast relief of headaches or other symptoms needing immediate relief.

ask your doctor about other uses for enteric-coated 81 mg Aspirin

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 50570-1 (50570-1)

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

Section 51945-4 (51945-4)

NDC 69168-066-02

Reliable-1

Adult Low Strength

Pain Reliever

Aspirin USP 81 mg (NSAID)

Enteric Coated

120 tablets

Compare to Active Ingredient in Aspirin Regimen BAYER®

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 60561-8 (60561-8)

Allergy Alert: Aspirin may cause a severe allergic reaction which may include:

- hives

- facial swelling

- shock

- asthma (wheezing)

Purpose

Pain reliever

Warnings

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.

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

Other Information (Other information)

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

- Use by expiration date on package

Inactive Ingredients (Inactive ingredients)

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

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

Aspirin 81 mg (NSAID*)

*nonsteroidal anti-inflamatory drug


Advanced Ingredient Data


Raw Label Data

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