Aspirin 81 Mg Enteric Coated: Package Insert and Label Information

ASPIRIN 81 MG ENTERIC COATED- aspirin tablet
Marlex Pharmaceuticals Inc

Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

ASPIRIN 81 MG TABLETS

Marlex Pharmaceuticals, Inc.

Active ingredient (in each tablet)

Purpose

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

Aspirin 81 mg Tablets

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

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

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 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

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.

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

Questions?

Adverse Drug Event Call: (800) 222-1222

Manufactured for & Distributed by:

Marlex Pharmaceuticals, Inc.

New Castle, DE 19720

Rev: 12/19 HP

PRINCIPAL DISPLAY PANEL

ASPIRIN
81mg120 Tablets

PRINCIPAL DISPLAY PANEL
ASPIRIN
81mg
120 Tablets
(click image for full-size original)
ASPIRIN 81 MG ENTERIC COATED aspirin tablet
Product Information
Product Type HUMAN OTC DRUG Item Code (Source) NDC:10135-689
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
ASPIRIN (ASPIRIN) ASPIRIN 81 mg
Inactive Ingredients
Ingredient Name Strength
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
Product Characteristics
Color YELLOW Score no score
Shape ROUND Size 5mm
Flavor Imprint Code A1
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:10135-689-62 120 TABLET in 1 BOTTLE None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
OTC MONOGRAPH NOT FINAL part343 02/01/2020
Labeler — Marlex Pharmaceuticals Inc (782540215)

Revised: 02/2020 Marlex Pharmaceuticals Inc

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