49483-390 Asa 81 Mg

Drug Facts

Composition & Product

Active Ingredients

Aspirin (81 mg)

Inactive Ingredients

Anhydrous Lactose Polysorbate 80 Dimethicone Croscarmellose Ferric Oxide Yellow D&c Yellow No. 10 Carnauba Wax Silicon Dioxide Microcrystalline Cellulose Methacrylic Acid - Methyl Methacrylate Copolymer (1:1) Sodium Hydroxide Sodium Lauryl Sulfate Talc Titanium Dioxide Triethyl Citrate

Identifiers & Packaging

Pill Appearance

Imprint: embossed;A;lower;plain Shape: round Color: yellow Size: 7 mm Score: 1

Marketing Status

OTC MONOGRAPH FINAL Active Since 2010-07-16

Medication Information

Warnings and Precautions

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

shock

asthma (wheezing)

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

have 3 or more alcoholic drinks every day while using this product

take more or for a longer time than directed

take other drugs containing prescription or nonprescription NSAIDs (aspirin, ibuprofen, naproxen, or others)

Indications and Usage

Uses

temporarily relieves minor aches and pains

for other uses, see your doctor, but do not use for more than 10 days without consulting your doctor because serious side effects may occur

Dosage and Administration

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

Description

Active ingredient (in each tablet) Aspirin 81 mg (NSAID*). . . . . . . . . . . . . . . . . . .Pain reliever *nonsteroidal anti-inflammatory drug

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 diabetes, gout, or arthritis

• under a doctor’s care for any serious condition

• taking any other drug

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

Ask a doctor or pharmacist before use if you are

• taking a prescription drug for diabetes, gout, or arthritis

• under a doctor’s care for any serious condition

• taking any other drug

Section 51727-6

anhydrous lactose, carnauba wax, colloidal silicon dioxide, croscarmellose sodium, d&c yellow#10 aluminum lake, iron oxide ochre, methacrylic acid and ethyl acrylate copolymer, microcrystalline cellulose, Polysorbate 80, simethicone, sodium hydroxide, sodium lauryl sulfate, talc, titanium dioxide, triethyl citrate

Section 51945-4

Enter section text here

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.

Keep out of reach of children. In case of overdose, get medical

help or contact a Poison Control Center right away.

Section 55105-1

Uses • temporarily relieves minor aches and pains

• for other uses, see your doctor, but do not use for more

than 10 days without consulting your doctor because

serious side effects may occur

Section 55106-9

Active ingredient (in each tablet)

Aspirin 81 mg (NSAID*). . . . . . . . . . . . . . . . . . .Pain reliever

*nonsteroidal anti-inflammatory drug

Structured Label Content

Indications and Usage (34067-9)

Uses

temporarily relieves minor aches and pains

for other uses, see your doctor, but do not use for more than 10 days without consulting your doctor because serious side effects may occur

Dosage and Administration (34068-7)

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

Warnings and Precautions (34071-1)

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

shock

asthma (wheezing)

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

have 3 or more alcoholic drinks every day while using this product

take more or for a longer time than directed

take other drugs containing prescription or nonprescription NSAIDs (aspirin, ibuprofen, naproxen, or others)

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 diabetes, gout, or arthritis

• under a doctor’s care for any serious condition

• taking any other drug

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

Ask a doctor or pharmacist before use if you are

• taking a prescription drug for diabetes, gout, or arthritis

• under a doctor’s care for any serious condition

• taking any other drug

Section 51727-6 (51727-6)

anhydrous lactose, carnauba wax, colloidal silicon dioxide, croscarmellose sodium, d&c yellow#10 aluminum lake, iron oxide ochre, methacrylic acid and ethyl acrylate copolymer, microcrystalline cellulose, Polysorbate 80, simethicone, sodium hydroxide, sodium lauryl sulfate, talc, titanium dioxide, triethyl citrate

Section 51945-4 (51945-4)

Enter section text here

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.

Keep out of reach of children. In case of overdose, get medical

help or contact a Poison Control Center right away.

Section 55105-1 (55105-1)

Uses • temporarily relieves minor aches and pains

• for other uses, see your doctor, but do not use for more

than 10 days without consulting your doctor because

serious side effects may occur

Section 55106-9 (55106-9)

Active ingredient (in each tablet)

Aspirin 81 mg (NSAID*). . . . . . . . . . . . . . . . . . .Pain reliever

*nonsteroidal anti-inflammatory drug

Advanced Ingredient Data

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Raw Label Data

All Sections (JSON)

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