Aspirin 81mg Tablets

Aspirin 81mg Tablets
SPL v5
SPL
SPL Set ID cc7013ea-cf30-6f59-e053-2a95a90a1148
Route
ORAL
Published
Effective Date 2021-09-20
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Aspirin (81 mg)
Inactive Ingredients
Titanium Dioxide D&c Yellow No. 10 Sodium Bicarbonate Sodium Lauryl Sulfate Starch, Corn Microcrystalline Cellulose Methacrylic Acid - Methyl Methacrylate Copolymer (1:1) Triethyl Citrate Silicon Dioxide Triacetin Povidone, Unspecified Stearic Acid Hypromellose, Unspecified Talc

Identifiers & Packaging

Pill Appearance
Imprint: S;17 Shape: round Color: yellow Size: 7 mm Score: 1
Marketing Status
OTC MONOGRAPH DRUG Active Since 2021-09-01

Description

Drug Fact

Purpose

Pain Reliever


Medication Information

Purpose

Pain Reliever

Description

Drug Fact

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 42229-5

Drug Fact

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

· 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

Do not useif you are allergic to aspirin or any other pain reliever/fever reducer

Questions?

Adverse Drug Event Call: (888) 582 1953or Email: [email protected]

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 permitted between 15-30°C (59-86°F)

· Use by expiration date on package

Inactive Ingredients:

Corn Starch, Pregelatinized Starch, Povidone, Microcrystalline Cellulose, Stearic Acid, Colloidal Silicon Dioxide, Methacrylic Acid Co-Polymer, Triethyl Citrate, Talc, Titanium Dioxide, Silica, Sodium bicarbonate, Sodium lauryl sulfate, D&C Yellow #10, Hypromellose, Triacetin

Principal Display Panel

Distributed by:

Marlex Pharmaceuticals, Inc.

New Castle, DE 19720

www.marlexpharm.com

NDC 10135-0729-10

NDC 10135-0729-62

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

Stop Use and Ask A Doctor If

· You experience 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

· Fever gets worse or lasts more than 3 days

· Redness or swelling is present in the painful area

· Any new symptoms appear

· Ringing in the ears or a loss of hearing occurs

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 problem 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.

Active Ingredient (in Each Tablet)

Aspirin 81mg (NSAID*)

*nonsteroidal anti-inflammatory drug

Ask A Doctor Or A 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


Structured Label Content

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 42229-5 (42229-5)

Drug Fact

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

· 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

· 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

Do not useif you are allergic to aspirin or any other pain reliever/fever reducer

Questions?

Adverse Drug Event Call: (888) 582 1953or Email: [email protected]

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 permitted between 15-30°C (59-86°F)

· Use by expiration date on package

Inactive Ingredients:

Corn Starch, Pregelatinized Starch, Povidone, Microcrystalline Cellulose, Stearic Acid, Colloidal Silicon Dioxide, Methacrylic Acid Co-Polymer, Triethyl Citrate, Talc, Titanium Dioxide, Silica, Sodium bicarbonate, Sodium lauryl sulfate, D&C Yellow #10, Hypromellose, Triacetin

Principal Display Panel (PRINCIPAL DISPLAY PANEL)

Distributed by:

Marlex Pharmaceuticals, Inc.

New Castle, DE 19720

www.marlexpharm.com

NDC 10135-0729-10

NDC 10135-0729-62

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

· You have not been drinking fluids

· You have lost a lot of fluid due to vomiting or diarrhea

Stop Use and Ask A Doctor If (Stop use and ask a doctor if)

· You experience 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

· Fever gets worse or lasts more than 3 days

· Redness or swelling is present in the painful area

· Any new symptoms appear

· Ringing in the ears or a loss of hearing occurs

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 definitely directed to do so by a doctor because it may cause problem in the unborn child or complications during delivery.

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

In case of overdose, get medical help or contact a Poison Control Center right away.

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

Aspirin 81mg (NSAID*)

*nonsteroidal anti-inflammatory drug

Ask A Doctor Or A Pharmacist Before Use If You Are (Ask a doctor or a 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


Advanced Ingredient Data


Raw Label Data

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