ASPIRIN tablet, film coated

Aspirin by

Drug Labeling and Warnings

Aspirin by is a Otc medication manufactured, distributed, or labeled by Chain Drug Marketing Association, 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
  
• take other drugs containing prescription or nonprescription NSAIDs [aspirin, ibuprofen, naproxen, or others]
  
• take more or for a longer time than directed
  
• have had stomach ulcers or bleeding problems
• have 3 or more alcoholic drinks every day while using this product

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

• you are taking a diuretic
  
• 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
  

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
    
• 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

QC®
QUALITY
CHOICE 

NDC: 83324-066-01

†Compare to the
Active Ingredient in
Genuine Bayer® Aspirin

Aspirin
(NSAID)

Pain Reliever
Fever Reducer 325 mg

Coated Tablets

100 Tablets

Actual Size

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       REV0122D15712

Distributed by CDMA, Inc.
Novi, MI 48375
www.qualitychoice.com
Questions: 800-935-2362

Quality Choice 44-157

INGREDIENTS AND APPEARANCE

ASPIRIN 
aspirin tablet, film coated

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 83324-066
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	ASPIRIN;44;157
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 83324-066-01	100 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	09/03/2024

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC Monograph Drug	M013	09/03/2024

Labeler - Chain Drug Marketing Association, Inc. (011920774)

Establishment
Name	Address	ID/FEI	Business Operations
LNK International, Inc.		038154464	pack(83324-066)

Establishment
Name	Address	ID/FEI	Business Operations
LNK International, Inc.		832867837	manufacture(83324-066)

Establishment
Name	Address	ID/FEI	Business Operations
LNK International, Inc.		832867894	manufacture(83324-066)

Establishment
Name	Address	ID/FEI	Business Operations
LNK International, Inc.		868734088	manufacture(83324-066)

Establishment
Name	Address	ID/FEI	Business Operations
LNK International, Inc.		967626305	pack(83324-066)