Aspirin by Trifecta Pharmaceuticals USA LLC ASPIRIN tablet

Aspirin by

Drug Labeling and Warnings

Aspirin by is a Otc medication manufactured, distributed, or labeled by Trifecta Pharmaceuticals USA LLC. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Active Ingredient

Aspirin 325mg (NSAID)

Nonsteroidal anti-inflammatory drug

Purpose

Pain Reliever / Fever Reducer

Do Not Use

• If you are allergic to aspirin or any other pain releiver / fever reducer
• If you have ever had an allergic reaction to this product or any of its ingredients

Uses

Temporarily relieves:

Headache

Pain and fever of colds

toothache

menstrual pain

muscle pain

minor pain of arthritis

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 behaviour with nausea and vomiting occur, consult a doctor because these symptoms could be an early sign of Reye's Syndrome, a reare but serious illness.

Allergy Alert

Aspirin may cause severe allergic reaction, which may include, facial swelling, hives, shock, asthma (wheezing).

Stomach bleeding warning

This product contains an NSAID which may cause severe stomach bleeding. The chance is higher if you

• Have had stomach ulcers or bleeding problems
• Take blood thinning (anticogulant) or steroid drug
• Are age 60 or older
• take other drugs containing prescription or non-prescription NSAIDs (aspirin, ibuprofen, naproxen or others)
• Take more or for a longer time than directed
• Have 3 or more alcoholic drinks every day while using this product

Ask a doctor before use if

• Stomach bleeding warning applies to you.
• You have a history of stomach problems, such as heartburn
• You have asthma
• You have high blood pressure, heart disease, liver cirrhosis or kidney disease.
• You are taking a diuretic

Ask a doctor or pharmacist before use if you are

taking a prescription drug for gout, diabetes, arthritis

Directions

Do not take more than directed. See overdose warning

Drink a full glass of water with each dose

Adults and children 12 years and older

• Take 1 or 2 tablets every 4 hours or 3 tablets every 6 hours not to exceed 12 tablets in 24 hours unless directed by a doctor.

Children under 12 years

• Do not use unless directed by a doctor

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 stools, have stomach pain that does not get better
• Ringing in the ears or loss of hearing occurs, pain gets worse or lasts more than 10 days, fever gets worse or lasts more than 3 days.
• New symptoms occur,
• Redness or swelling is present
• Thse 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 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.

Other Information

• Store at 25ºC (77ºF)
• Excursions permitted between 15ºC-30ºC (59ºF-86ºF)
• See end flap for expiration date and lot number
• Use by expiration date on package

Inactive Ingredients

Corn Starch, Hyperomelose, Polyethylene glycol, propylene glycol

Keep out of reach of children

In case of overdose, get medical help or contact a poison control center right away.

Questions or Comments?

Call 1-888-296-9067

Distributed By:

Distributed By:

Trifecta Pharmaceuticals USA®

Ft. Lauderdale, FL. 33301 USA

1-888-296-9067

*This product is not manufactured or distributed by the Bayer Healthcare LLC. owner of the registered trademark Bayer®

Reorder No. 2023

Made in the USA

Label

INGREDIENTS AND APPEARANCE

ASPIRIN 
aspirin tablet

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 69396-158
Route of Administration	ORAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
ASPIRIN (UNII: R16CO5Y76E) (ASPIRIN - UNII:R16CO5Y76E)	ASPIRIN	325 mg

Inactive Ingredients
Ingredient Name	Strength
STARCH, CORN (UNII: O8232NY3SJ)
HYPROMELLOSE, UNSPECIFIED (UNII: 3NXW29V3WO)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A)

Product Characteristics
Color	white	Score	score with uneven pieces
Shape	ROUND	Size	10mm
Flavor		Imprint Code	44157
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 69396-158-01	50 in 1 BOX	08/24/2024
1		2 in 1 PACKET; 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	08/24/2024

Labeler - Trifecta Pharmaceuticals USA LLC (079424163)