Drug Facts

Drug Facts
SPL v1
SPL
SPL Set ID 305170b7-8cd8-405d-b556-445a4268d617
Route
ORAL
Published
Effective Date 2018-05-31
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

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

Identifiers & Packaging

Pill Appearance
Imprint: AZ013 Shape: round Color: orange Size: 7 mm Score: 1
Marketing Status
OTC MONOGRAPH NOT FINAL Active Since 2014-12-18

Description

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

Purpose

Pain reliever/fever reducer

How Supplied

Product: 50090-2898 NDC: 50090-2898-1 30 TABLET in a BLISTER PACK / 25 in a BOX, UNIT-DOSE


Medication Information

Purpose

Pain reliever/fever reducer

How Supplied

Product: 50090-2898

NDC: 50090-2898-1 30 TABLET in a BLISTER PACK / 25 in a BOX, UNIT-DOSE

Description

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

Uses

temporary relief of minor aches and pains or as recommended by your doctor to reduce fever

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 alcoholic drinks every day while using this product ■ take more or for a longer time than directed

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

Do Not Use

if you are allergic to aspirinor any other pain reliever/fever reducer this product for at least 7 days after tonsillectomy or oral surgery unless directed by a doctor

Aspirin 81 Mg
Active Ingredient

Aspirin 81 mg (NSAID*)

*nonsteroidal anti-inflammatory drug

Inactive Ingredients

dextrates, FD&C yellow #6, flavor, saccharin sodium, starch

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 redness or swelling is present new symptoms occur ringing in the ears or loss of hearing occurs

You may report side effects to 1-888-952-0050

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

Keep Out of Reach of Children

In case of accidental overdose, get medical help or contact a PoisonControlCenter right away.

Ask A Doctor Or Pharmacist Before Use If You Are

taking a prescription drug for gout diabetes arthritis


Structured Label Content

Uses

temporary relief of minor aches and pains or as recommended by your doctor to reduce fever

Purpose

Pain reliever/fever reducer

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 alcoholic drinks every day while using this product ■ take more or for a longer time than directed

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

Do Not Use (Do not use)

if you are allergic to aspirinor any other pain reliever/fever reducer this product for at least 7 days after tonsillectomy or oral surgery unless directed by a doctor

How Supplied (HOW SUPPLIED)

Product: 50090-2898

NDC: 50090-2898-1 30 TABLET in a BLISTER PACK / 25 in a BOX, UNIT-DOSE

Aspirin 81 Mg (Aspirin 81 mg)
Active Ingredient (Active ingredient)

Aspirin 81 mg (NSAID*)

*nonsteroidal anti-inflammatory drug

Inactive Ingredients

dextrates, FD&C yellow #6, flavor, saccharin sodium, starch

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 redness or swelling is present new symptoms occur ringing in the ears or loss of hearing occurs

You may report side effects to 1-888-952-0050

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

Keep Out of Reach of Children

In case of accidental overdose, get medical help or contact a PoisonControlCenter right away.

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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