Aspirin 81mg Enteric Coated Tablets

Aspirin 81mg Enteric Coated Tablets
SPL v4
SPL
SPL Set ID e35ebda4-aff9-4870-81e2-85b85e5c4db1
Route
ORAL
Published
Effective Date 2020-02-17
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Aspirin (81 mg)
Inactive Ingredients
Microcrystalline Cellulose Croscarmellose Sodium Starch, Corn Stearic Acid Silicon Dioxide Methacrylic Acid - Ethyl Acrylate Copolymer (1:1) Type A Triethyl Citrate Talc Titanium Dioxide D&c Yellow No. 10 Fd&c Yellow No. 6

Identifiers & Packaging

Pill Appearance
Imprint: A1 Shape: round Color: yellow Size: 5 mm Score: 1
Marketing Status
OTC MONOGRAPH NOT FINAL Active Since 2020-02-01

Description

ASPIRIN   81 MG TABLETS Marlex Pharmaceuticals, Inc. ----------

Purpose

Drug Fact Active ingredient (in each tablet) Purpose  Aspirin 81mg (NSAID*)…………………………………………Pain Reliever *nonsteroidal anti-inflammatory drug Aspirin 81 mg Tablets


Medication Information

Purpose
Drug Fact
Active ingredient (in each tablet) Purpose
 Aspirin 81mg (NSAID*)…………………………………………Pain Reliever

*nonsteroidal anti-inflammatory drug

Aspirin 81 mg Tablets

Description

ASPIRIN   81 MG TABLETS Marlex Pharmaceuticals, Inc. ----------

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

ASPIRIN   81 MG TABLETS

Marlex Pharmaceuticals, Inc.

----------

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 Use

if you are allergic to aspirin or any other pain reliever/fever reducer

Questions?

Adverse Drug Event Call: (800) 222-1222

Manufactured for & Distributed by:

Marlex Pharmaceuticals, Inc.

New Castle, DE 19720

Rev: 12/19 HP

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:

Microcrystalline Cellulose, Croscarmellose Sodium, Pregelatinized Starch, Stearic Acid, Colloidal Silicon Dioxide, Methacrylic Acid and Ethyl Acrylate Co-Polymer, Triethyl Citrate, Talc, Titanium Dioxide, D&C Yellow #10, FD&C Yellow #6

Principal Display Panel

ASPIRIN

81mg

120 Tablets

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

  • 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.

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)

ASPIRIN   81 MG TABLETS

Marlex Pharmaceuticals, Inc.

----------

Purpose
Drug Fact
Active ingredient (in each tablet) Purpose
 Aspirin 81mg (NSAID*)…………………………………………Pain Reliever

*nonsteroidal anti-inflammatory drug

Aspirin 81 mg Tablets

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 Use (Do not use)

if you are allergic to aspirin or any other pain reliever/fever reducer

Questions?

Adverse Drug Event Call: (800) 222-1222

Manufactured for & Distributed by:

Marlex Pharmaceuticals, Inc.

New Castle, DE 19720

Rev: 12/19 HP

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:

Microcrystalline Cellulose, Croscarmellose Sodium, Pregelatinized Starch, Stearic Acid, Colloidal Silicon Dioxide, Methacrylic Acid and Ethyl Acrylate Co-Polymer, Triethyl Citrate, Talc, Titanium Dioxide, D&C Yellow #10, FD&C Yellow #6

Principal Display Panel (PRINCIPAL DISPLAY PANEL)

ASPIRIN

81mg

120 Tablets

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

  • 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.

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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