ASPIRIN DELAYED RELEASE 81MG tablet, coated

ASPIRIN DELAYED RELEASE 81MG by

Drug Labeling and Warnings

ASPIRIN DELAYED RELEASE 81MG by is a Otc medication manufactured, distributed, or labeled by Farmacias De Similares TX LLC, Elysium Pharmaceuticals Ltd, Green Star Labs, Inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Active ingredient (in each caplet)

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

Purpose

Pain Reliever

Uses

for the temporary relief of minor aches and pains or as recommended by your doctor. Because of its delayed release action, this product will not provide fast relief of headache or symptoms needing immediate relief.

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 . shock . facial swelling . 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
. if you have ever had an allergic reaction to this product or any of its ingredients

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 have asthma
. You are taking a diuretic

Ask a doctor or pharmacist before use if you are

Taking a prescription drug for . gout . diabetes . arthritis

Stop use and ask a doctor if

. An allergic reaction occurs. Seek medical help right away

. You experience any of the following signs of stomach bleeding:
-Vomit blood -Have bloody or black stools -Feel faint -Have stomach pain that does not get better

. Ringing in the ears or a loss of hearing occurs

. Pain gets worse or lasts more than 10 days

. Fever gets worse or lasts more than 3 days

. Redness or swelling is present

. New symptoms occur

These could be signs of a serious condition.

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 problems 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 (1-800-222-1222). Quick medical attention is critical for adults as well as for children even if you do not notice any signs or symptoms.

Directions

. Drink a full glass of water with each dose.
. Adults and children 12 years and over:
Take 4 to 8 caplets every 4 hours not to exceed 48 caplets in 24 hours unless directed by a doctor.
. Children under 12 years: Ask a doctor.

Other information

. Store at room temperature 15-30°C (59-86°F)
. Read all product information before using

Inactive ingredients

Colloidal silicon dioxide, croscarmellose sodium, D&C Yellow No. 10, lactose, methacrylic acid copolymer, microcrystalline cellulose, polysorbate 80, sodium hydroxide, talc, titanium dioxide, triethyl citrate, yellow iron oxide

Questions or comments?

(855)-280-1079

SPL UNCLASSIFIED SECTION

t This product is not manufactured or distributed by Bayer HealthCare LLC., owner of the registered trademark Bayer® Low Dose Aspirin.

Distributed in USA by: FARMACIAS DE SIMILARES
TXLLC 800 Brazos St Ste 260, Austin, TX, 78701, USA
customerservice@drsimi.com www.drsimi.com

PRINCIPAL DISPLAY PANEL

Dr. Simi

Compare to the active ingredient in Bayer® Low Dose Aspirin t

NDC: 85786-106-60

Aspirin 81 mg
Pain Reliever (NSAID)

Talk to your doctor or other healthcare provider before using this product for your heart.

60 Enteric Coated Caplets

INGREDIENTS AND APPEARANCE

ASPIRIN DELAYED RELEASE 81MG 
aspirin delayed release 81mg tablet, coated

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 85786-106
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
BUTYL ACRYLATE/METHYL METHACRYLATE/METHACRYLIC ACID COPOLYMER (18000 MW) (UNII: JZ1374NL9E)
LACTOSE (UNII: J2B2A4N98G)
TALC (UNII: 7SEV7J4R1U)
POLYSORBATE 80 (UNII: 6OZP39ZG8H)
D&C YELLOW NO. 10 (UNII: 35SW5USQ3G)
MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U)
SODIUM HYDROXIDE (UNII: 55X04QC32I)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)
TRIETHYL CITRATE (UNII: 8Z96QXD6UM)
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
CROSCARMELLOSE SODIUM (UNII: M28OL1HH48)
FERRIC OXIDE YELLOW (UNII: EX438O2MRT)

Product Characteristics
Color	yellow	Score	no score
Shape	ROUND	Size	8mm
Flavor		Imprint Code	81
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 85786-106-60	60 in 1 CARTON; Type 0: Not a Combination Product	01/01/2026

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC Monograph Drug	M013	01/01/2026

Labeler - Farmacias De Similares TX LLC (119489934)

Establishment
Name	Address	ID/FEI	Business Operations
Elysium Pharmaceuticals Ltd		863182240	manufacture(85786-106)

Establishment
Name	Address	ID/FEI	Business Operations
Green Star Labs, Inc.		118673251	pack(85786-106)