ASPIRIN 81 MG ENTERIC COATED- aspirin tablet

Aspirin 81 mg Enteric Coated by

Drug Labeling and Warnings

Aspirin 81 mg Enteric Coated by is a Otc medication manufactured, distributed, or labeled by Marlex Pharmaceuticals Inc. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

SPL UNCLASSIFIED SECTION

ASPIRIN 81MG TABLETS

Marlex Pharmaceuticals, Inc.

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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
81mg
120 Tablets

INGREDIENTS AND APPEARANCE

ASPIRIN 81 MG ENTERIC COATED 
aspirin tablet

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 10135-689
Route of Administration	ORAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
ASPIRIN (UNII: R16CO5Y76E) (ASPIRIN - UNII:R16CO5Y76E)	ASPIRIN	81 mg

Inactive Ingredients
Ingredient Name	Strength
MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U)
CROSCARMELLOSE SODIUM (UNII: M28OL1HH48)
STARCH, CORN (UNII: O8232NY3SJ)
STEARIC ACID (UNII: 4ELV7Z65AP)
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
METHACRYLIC ACID - ETHYL ACRYLATE COPOLYMER (1:1) TYPE A (UNII: NX76LV5T8J)
TRIETHYL CITRATE (UNII: 8Z96QXD6UM)
TALC (UNII: 7SEV7J4R1U)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)
D&C YELLOW NO. 10 (UNII: 35SW5USQ3G)
FD&C YELLOW NO. 6 (UNII: H77VEI93A8)

Product Characteristics
Color	YELLOW	Score	no score
Shape	ROUND	Size	5mm
Flavor		Imprint Code	A1
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 10135-689-62	120 in 1 BOTTLE; Type 0: Not a Combination Product	02/01/2020

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)