Aspirin by Marlex Pharmaceuticals Inc. ASPIRIN tablet

Aspirin by

Drug Labeling and Warnings

Aspirin 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

Drug Fact

Active ingredient (in each tablet)

Aspirin 81mg (NSAID*)

*nonsteroidal anti-inflammatory drug

Purpose

Pain Reliever

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 useif 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
· 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.

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

Questions?

Adverse Drug Event Call: (888) 582 1953or Email: drugsafety@marlexpharm.com

PRINCIPAL DISPLAY PANEL

Distributed by:

Marlex Pharmaceuticals, Inc.

New Castle, DE 19720

Rev.1 09/21 AA

www.marlexpharm.com

NDC: 10135-0729-62

INGREDIENTS AND APPEARANCE

ASPIRIN 
aspirin tablet

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 10135-729
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
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)
D&C YELLOW NO. 10 (UNII: 35SW5USQ3G)
SODIUM BICARBONATE (UNII: 8MDF5V39QO)
SODIUM LAURYL SULFATE (UNII: 368GB5141J)
STARCH, CORN (UNII: O8232NY3SJ)
MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U)
METHACRYLIC ACID - METHYL METHACRYLATE COPOLYMER (1:1) (UNII: 74G4R6TH13)
TRIETHYL CITRATE (UNII: 8Z96QXD6UM)
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
TRIACETIN (UNII: XHX3C3X673)
POVIDONE, UNSPECIFIED (UNII: FZ989GH94E)
STEARIC ACID (UNII: 4ELV7Z65AP)
HYPROMELLOSE, UNSPECIFIED (UNII: 3NXW29V3WO)
TALC (UNII: 7SEV7J4R1U)

Product Characteristics
Color	yellow	Score	no score
Shape	ROUND	Size	7mm
Flavor		Imprint Code	S;17
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 10135-729-62	120 in 1 BOTTLE; Type 0: Not a Combination Product	09/01/2021

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC Monograph Drug	M013	09/01/2021

Labeler - Marlex Pharmaceuticals Inc. (782540215)