Your browser does not support JavaScript! ASPIRIN TABLET [CARDINAL HEALTH]
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ASPIRIN tablet
[Cardinal Health]


Category DEA Schedule Marketing Status
HUMAN OTC DRUG LABEL unapproved drug other
NOTE:THIS DRUG HAS NOT BEEN FOUND BY FDA TO BE SAFE AND EFFECTIVE, AND THIS LABELING HAS NOT BEEN APPROVED BY FDA. For further information about unapproved drugs, click here.
Drug Label Sections

Active ingredient (in each tablet)

Aspirin 81 mg (NSAID)*

*nonsteroidal anti-inflammatory drug

Chewable

Low Dose

Orange Flavor

Aspirin Regimen**

Gluten Free

Purpose

Pain reliever

Uses

for the temporary relief of minor aches and pains

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

**Aspirin is not appropriate for eveyone, so be sure to talk to you doctor before you begin and aspirin regimen.

Do not use

•if you have ever had an allergic reaction to any other pain reliever/fever reducer
•for at least 7 days after tonsillectomy or oral surgery unless directed by a doctor

Ask a doctor before use if

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

Ask a doctor or pharmacist before use if you are

taking a prescription drug for diabetes, gout or 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 for more than 10 days
•fever gets worse or lasts for more than 3 days
•redness or swelling is present
•new symptoms occur
•ringing in the ears or loss of hearing occurs

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 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.

Warning: Keep out of reach of children.

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

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 20-25°C (68-77°F)

COMPARE TO the active ingredient of BAYER® CHEWABLE ASPIRIN ***

***Major® Aspirin 81 mg is not manufactured or distributed by Bayer HealthCare LLC, distributor of Bayer Chewable A

Gluten Free

Bulk Manufacturer NDC 0904-4040-73

Inactive ingredients

corn starch, dextrose excipient, FD&C yellow no. 6 aluminum lake, flavors, saccharin sodium

Questions or comments?

1-800-616-2471

Distributed by

MAJOR PHARMACEUTICALS

31778 Enterprise Drive

Livonia, MI 48150 USA

Rev. 11/11

Repackaged by Cardinal Health

Zanesville, OH 43701

IE70130713

Principal Display Panel

Aspirin

Pain Reliever (NSAID) tablets

81 mg

Contains Approximately 2052 Tablets

Bottle Label
ASPIRIN 
aspirin tablet
Product Information
Product TypeHUMAN OTC DRUG LABELItem Code (Source)NDC:55154-0748(NDC:0904-4040)
Route of AdministrationORALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ASPIRIN (ASPIRIN) ASPIRIN81 mg
Inactive Ingredients
Ingredient NameStrength
DEXTROSE 
FD&C YELLOW NO. 6 
SACCHARIN 
STARCH, CORN 
Product Characteristics
ColorORANGEScoreno score
ShapeROUNDSize8mm
FlavorORANGEImprint Code L467
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:55154-0748-82052 in 1 BOTTLE, PLASTIC
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
Unapproved drug other05/23/2011
Labeler - Cardinal Health (188557102)
Establishment
NameAddressID/FEIBusiness Operations
Cardinal Health188557102REPACK(55154-0748)

Revised: 4/2014
 
Cardinal Health

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