Drug Facts

Drug Facts
SPL v4
SPL
SPL Set ID f4aa0de9-ffcc-4140-91a3-fd9e7a55f2ac
Route
ORAL
Published
Effective Date 2023-12-06
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

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

Identifiers & Packaging

Pill Appearance
Imprint: AZ;013 Shape: round Color: orange Size: 8 mm Score: 1
Marketing Status
OTC MONOGRAPH DRUG Active Since 2016-03-29

Description

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

Purpose

Pain reliever 


Medication Information

Purpose

Pain reliever 

Description

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

Uses

for the temporary relief of minor aches and paines or as recommended by your doctor

Section 51945-4
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 NSAID, which may cause severe stomach bleeding.  The chance is higher if you:

-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)

-Take more or for a longer time than directed

-Are age 60 or older

-Have 3 or more alcoholic drinks every day while using this product

Do not use:

-if you are allergic to aspirin or other pain relievers / fever reducers

-For at least 7 days after tonsillectomy or oral surgery unless directed by a doctor

-If you have ever had an allergic reaction to this product or any of its ingredients

Ask a doctor before use if:

-Stomach bleeding warning applies to user

-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

Ask a doctor of pharmacist before use if youare taking a prescription drug for diabetes, gout, or arthritis.

Stop use and ask a doctor if:

-You experience any of the following signs of stomach bleeding: feel faint, vomit blood, has bloody or black stool, has stomach pain that does not get better

-An allergic reaction occurs.  Seek medical help help right away

-New symptoms occur

-Redness or swelling is present

-Pain gets worse or lasts for more than 10 days

-Ringing in the ears or loss of hearing occurs

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

If p regnant 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 unborn child or complications during delivery.

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:consult a doctor

Active Ingredient

Aspirin 81 mg (NSAID*)

*nonsteroidal anti-inflammatory drug

Inactive Ingredients

corn starch, dextrates, FD C yellow 6 aluminum lake, orange flavor, saccharin sodium

Keep Out of Reach of Children.

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


Structured Label Content

Uses

for the temporary relief of minor aches and paines or as recommended by your doctor

Section 51945-4 (51945-4)
Purpose

Pain reliever 

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 NSAID, which may cause severe stomach bleeding.  The chance is higher if you:

-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)

-Take more or for a longer time than directed

-Are age 60 or older

-Have 3 or more alcoholic drinks every day while using this product

Do not use:

-if you are allergic to aspirin or other pain relievers / fever reducers

-For at least 7 days after tonsillectomy or oral surgery unless directed by a doctor

-If you have ever had an allergic reaction to this product or any of its ingredients

Ask a doctor before use if:

-Stomach bleeding warning applies to user

-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

Ask a doctor of pharmacist before use if youare taking a prescription drug for diabetes, gout, or arthritis.

Stop use and ask a doctor if:

-You experience any of the following signs of stomach bleeding: feel faint, vomit blood, has bloody or black stool, has stomach pain that does not get better

-An allergic reaction occurs.  Seek medical help help right away

-New symptoms occur

-Redness or swelling is present

-Pain gets worse or lasts for more than 10 days

-Ringing in the ears or loss of hearing occurs

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

If p regnant 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 unborn child or complications during delivery.

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:consult a doctor

Active Ingredient

Aspirin 81 mg (NSAID*)

*nonsteroidal anti-inflammatory drug

Inactive Ingredients

corn starch, dextrates, FD C yellow 6 aluminum lake, orange flavor, saccharin sodium

Keep Out of Reach of Children. (Keep out of reach of children.)

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


Advanced Ingredient Data


Raw Label Data

All Sections (JSON)