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:

• asthma (wheezing) 
• hives
• facial swelling
• 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]
• take more or for a longer time than directed
• 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

• 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

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 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
  

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.

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 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

• store at 25ºC (77ºF); excursions permitted between 15º-30ºC (59º-86ºF)
• use by expiration date on package

Inactive ingredients

corn starch, hypromellose, polyethylene glycol, propylene glycol

Questions or comments?

1-800-426-9391

Principal Display Panel

NDC: 63868-352-03

QC®
QUALITY
CHOICE

†Compare to the
  active ingredient in
  Genuine BAYER® Aspirin

Aspirin
(NSAID)

Pain Reliever
Fever Reducer   325 mg

Coated Tablets
Easy to Swallow

300 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 HealthCare LLC, owner of the registered trademark Genuine Bayer® Aspirin.
50844         REV0318B15717

Distributed by C.D.M.A., Inc.©
43157 W. 9 Mile Rd
Novi, MI 48375
www.qualitychoice.com
Questions: 248-449-9300

Quality Choice 44-157

INGREDIENTS AND APPEARANCE

ASPIRIN 
aspirin tablet, film coated

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 63868-352
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	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: 63868-352-03	300 in 1 BOTTLE; Type 0: Not a Combination Product	02/10/1996
2	NDC: 63868-352-10	100 in 1 BOTTLE; Type 0: Not a Combination Product	02/10/1996

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC MONOGRAPH NOT FINAL	part343	02/10/1996

Labeler - CHAIN DRUG MARKETING ASSOCIATION INC (011920774)

Establishment
Name	Address	ID/FEI	Business Operations
LNK International, Inc.		038154464	PACK(63868-352)

Establishment
Name	Address	ID/FEI	Business Operations
LNK International, Inc.		832867837	MANUFACTURE(63868-352)

Establishment
Name	Address	ID/FEI	Business Operations
LNK International, Inc.		967626305	PACK(63868-352)

Establishment
Name	Address	ID/FEI	Business Operations
LNK International, Inc.		868734088	PACK(63868-352)