ASPIRIN 81 MG- aspirin enteric coated tablets 81 mg tablet, delayed release

Aspirin 81 mg by

Drug Labeling and Warnings

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

Drug Details [pdf]

INACTIVE INGREDIENT

corn starch, pregelatinized starch, povidone. microcrystalline cellulose, colloidal silicon dioxide, stearic acid, methacrylic acid and ethyl acrylate copolymer, talc, titanium dioxide, triethyl citrate, sodium bicarbonate, sodium lauryl sulfate, d&c yellow #10, hypromellose, triacetin

ACTIVE INGREDIENT

Aspirin 81 mg (NSAID*) *nonsteroidal anti-inflammatory drug

ASK DOCTOR

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 DOCTOR/PHARMACIST

Ask a doctor or pharmacist before use if you are - taking a prescription drug for diabetes, gout, or arthritis - taking any other drug - under a doctor's care for any serious condition

Aspirin Drug Facts

Do not use: if you are allergic to aspirin or any other pain reliver/fever reducer

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.

PREGNANCY 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 becwause it may cause problems in the unborn child or complications during delivery.

PURPOSE

Pain reliever

STOP USE

Stop use and ask a doctor if - an allergic reaction occurs. Seek medical help right away. - you are experierance 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 - new symptoms occur - ringing in the ears or a loss of hearing occurs. these could be signs of a serious condition.

DOSAGE & ADMINISTRATION

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

WARNINGS

Reye's syndrome: Children and teenagers who have or are recoving 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 early sign of Reye's syndrome, a rare but serious illness.

SPL UNCLASSIFIED SECTION

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 steriod drug - take other drugs contiaining prescription or nonprescription NSAIDs (aspirin, ibuprofen, naprozen, or others) - have 3 or more alcoholic drinks every day while using this product - take more or for longer time than directed

OTHER SAFETY INFORMATION

Allergy Alert: Aspirin may cause a severe allergic reaction which may include: - hives - facial swelling - shock - asthma (wheezing)

INDICATIONS & USAGE

Pin Reliever

PRINCIPAL DISPLAY PANEL

NDC: 71406-128-12 AACE Pharmaceuticals - Adult Low Strength - Pain Reliever - Aspirin USP 81 mg (NSAID) Enteric Coated - 120 tablets - Compare to Active Ingredient in Aspirin Regimen BAYER®

NDC: 71406-128-10 AACE Pharmaceuticals - Adult Low Strength - Pain Reliever - Aspirin USP 81 mg (NSAID) Enteric Coated - 1000 tablets - Compare to Active Ingredient in Aspirin Regimen BAYER®

INGREDIENTS AND APPEARANCE

ASPIRIN 81 MG 
aspirin enteric coated tablets 81 mg tablet, delayed release

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 71406-128
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
TRIACETIN (UNII: XHX3C3X673)
STEARIC ACID (UNII: 4ELV7Z65AP)
POVIDONE (UNII: FZ989GH94E)
TRIETHYL CITRATE (UNII: 8Z96QXD6UM)
SODIUM LAURYL SULFATE (UNII: 368GB5141J)
MICROCRYSTALLINE CELLULOSE 102 (UNII: PNR0YF693Y)
STARCH, CORN (UNII: O8232NY3SJ)
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
METHACRYLIC ACID AND ETHYL ACRYLATE COPOLYMER (UNII: NX76LV5T8J)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)
SODIUM BICARBONATE (UNII: 8MDF5V39QO)
TALC (UNII: 7SEV7J4R1U)
D&C YELLOW NO. 10 (UNII: 35SW5USQ3G)
HYPROMELLOSE 2910 (6 MPA.S) (UNII: 0WZ8WG20P6)
MICROCRYSTALLINE CELLULOSE 200 (UNII: 5XDI2TS1EZ)

Product Characteristics
Color	yellow	Score	no score
Shape	ROUND	Size	8mm
Flavor		Imprint Code	S17
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 71406-128-10	1000 in 1 BOTTLE; Type 0: Not a Combination Product	05/14/2021
2	NDC: 71406-128-12	120 in 1 BOTTLE; Type 0: Not a Combination Product	05/14/2021

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC Monograph Drug	M013	05/03/2021

Labeler - AACE Pharmaceuticals, Inc. (080630748)