ASPIRIN tablet, film coated

Aspirin by

Drug Labeling and Warnings

Aspirin by is a Otc medication manufactured, distributed, or labeled by Geiss, Destin & Dunn Inc., LNK International, Inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Active ingredient (in each tablet)

Aspirin 325 mg (NSAID)*
*nonsteroidal anti-inflammatory drug

Purpose

Pain reliever/fever reducer

Uses

temporarily relieves:

• minor pain of arthritis
• headache
• muscle pain
• menstrual pain
• toothache
• pain and fever of colds

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:

• facial swelling
• shock
• hives
• 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
• take a blood thinning (anticoagulant) or steroid drug
• have 3 or more alcoholic drinks every day while using this product
• have had stomach ulcers or bleeding problems
• take more or for a longer time than directed
• take other drugs containing prescription or nonprescription NSAIDs [aspirin, ibuprofen, naproxen, or others]

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 are taking a diuretic
• you have high blood pressure, heart disease, liver cirrhosis, or kidney disease
• 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:
  • 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 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 right away.

Directions

• do not take more than directed
• drink a full glass of water with each dose
• adults and children 12 years and over: 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

Other information

• use by expiration date on package
• store at 25°C (77°F); excursions permitted between 15°-30°C (59°-86°F)

Inactive ingredients

corn starch, hypromellose, polyethylene glycol, propylene glycol

Questions or comments?

1-800-426-9391

Principal display panel

GoodSense®

NDC: 50804-157-12

Aspirin
Pain Reliever/Fever Reducer
(NSAID)

Safe Pain Relief

actual size

†Compare to the active ingredient of
Genuine Bayer® Aspirin

100 Tablets - 325 mg each

TAMPER EVIDENT: DO NOT USE IF IMPRINTED SAFETY
SEAL UNDER CAP IS BROKEN OR MISSING

†This product is not manufactured or distributed by Bayer AG, owner of the registered
trademark Genuine Bayer® Aspirin.          50844          ORG012215712

Distributed by:
Perrigo Direct, Inc.,
Peachtree City, GA 30269
www.PerrigoDirect.com
(1-800-426-9391)
GoodSense® is a registered
trademark of L. Perrigo
Company.

GoodSense 44-157

INGREDIENTS AND APPEARANCE

ASPIRIN 
aspirin tablet, film coated

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 50804-157
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)
POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)

Product Characteristics
Color	white	Score	no score
Shape	ROUND	Size	10mm
Flavor		Imprint Code	44;157;ASPIRIN
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 50804-157-12	100 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	05/12/2023

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC Monograph Drug	M013	05/12/2023

Labeler - Geiss, Destin & Dunn Inc. (076059836)

Establishment
Name	Address	ID/FEI	Business Operations
LNK International, Inc.		038154464	pack(50804-157)

Establishment
Name	Address	ID/FEI	Business Operations
LNK International, Inc.		832867837	manufacture(50804-157)

Establishment
Name	Address	ID/FEI	Business Operations
LNK International, Inc.		832867894	manufacture(50804-157)

Establishment
Name	Address	ID/FEI	Business Operations
LNK International, Inc.		868734088	manufacture(50804-157)

Establishment
Name	Address	ID/FEI	Business Operations
LNK International, Inc.		967626305	pack(50804-157)