ASPIRIN 81MG- aspirin tablet, chewable

Aspirin 81mg by

Drug Labeling and Warnings

Aspirin 81mg by is a Otc medication manufactured, distributed, or labeled by Gendose Pharmaceuticals, LLC, Allegiant Health. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Active ingredient (in each tablet)

Aspirin 81 mg (NSAID**)

**nonsteroidal anti-inflammatory drug

Purpose

Pain Reliever

Uses

• for temporary relief of minor aches and pains or as recommended by your doctor.
• ask your doctor for other uses of this product.

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
• asthma (wheezing)
• shock

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. 
• this product for at least 7 days after tonsillectomy or oral surgery unless directed by a doctor.
• if you have ever had an allergic reaction to this product or any of its ingredients.

Ask a doctor before use if

• the 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

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:

  feel faint

  vomit blood

  have bloody or black stools

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

new symptoms occur

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 at 20 weeks or later in 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.

In case of overdose, get medical help or contact a Poison Control Center (1-800-222-1222) 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)

Inactive ingredients

dextrates, FD&C yellow #6 aluminum lake, orange flavor, saccharin sodium, corn starch

Principal Display Panel

INGREDIENTS AND APPEARANCE

ASPIRIN 81MG 
aspirin tablet, chewable

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 77333-049
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
DEXTRATES (UNII: G263MI44RU)
FD&C YELLOW NO. 6 ALUMINUM LAKE (UNII: GYP6Z2JR6Q)
SACCHARIN SODIUM (UNII: SB8ZUX40TY)
STARCH, CORN (UNII: O8232NY3SJ)

Product Characteristics
Color	orange	Score	no score
Shape	ROUND	Size	8mm
Flavor		Imprint Code	AZ013
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 77333-049-20	150 in 1 CARTON	05/01/2025
1	NDC: 77333-049-25	1 in 1 BLISTER PACK; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC Monograph Drug	M013	05/01/2025

Labeler - Gendose Pharmaceuticals, LLC (080257510)

Establishment
Name	Address	ID/FEI	Business Operations
Allegiant Health		079501930	manufacture(77333-049)