DrugCite

ASPIRIN - aspirin tablet 
Major Pharmaceuticals

DRUG FACTS

ACTIVE INGREDIENTS

Drug Facts
Active ingredient (in each tablet) Purpose
Aspirin 81 mg (NSAID*). . . . . . . . . . . . . . . . . . .Pain reliever
*nonsteroidal anti-inflammatory drug

Uses

temporarily relieves minor aches and pains

for other uses, see your doctor, but do not use for more than 10 days without consulting your doctor because serious side effects may occur

Stop use and ask a doctor if

you experience the following signs of stomach bleeding: • feel faint
• have bloody or black stools • vomit blood
• have stomach pain that does not get better
• pain gets worse or lasts more than 10 days
• fever gets worse or lasts more than 3 days
• redness or swelling is present in the painful area
• any new symptoms appear
• ringing in the ears or a loss of hearing occurs

Ask a doctor before use if

 • 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 are taking a diuretic • you have asthma • you
have not been drinking fluids • you have lost a lot of
fluid due to vomiting or diarrhea

Ask a doctor or pharmacist before use if you are

• taking a prescription drug for diabetes, gout, or arthritis
• under a doctor’s care for any serious condition
• taking any other drug

Drug Facts

Main Panel

Drug Facts Continued

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, shock, facial swelling, 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, have had stomach ulcers or bleeding problems, take a blood thinning (anticoagulant) or steroid drug, take other drugs containing prescription or nonprescritpion 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.

Do not use

 if you are allergic to aspirin or any other pain reliever/fever reducer

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

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

 TAMPER EVIDENT:  DO NOT USE THIS PRODUCT IF THE IMPRINTED FOIL SEAL OVER THE MOUTH OF THE BOTTLE IS CUT, TORN, BROKEN OR MISSING

store at 25ºC (77ºF) excursions permitted between 15º - 30ºC (59º-86ºF)

use by expiration date on package

Keep out of reach of children

 In case of overdose, get medical help or contact Poison Control Center right away

Inactive Ingredients

 BHT, dextrates, FD&C yellow #6 aluminum lake, microcrystalline cellulose, modified corn starch, orange flavor, pregelantinized starch, sodium saccharin, stearic acid

Purpose

 temporarily relieves minor aches and pains


ASPIRIN 
aspirin  tablet
Product Information
Product Type HUMAN OTC DRUG NDC Product Code (Source) 0904-6288 (49483-381)
Route of Administration ORAL DEA Schedule     
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
ASPIRIN (ASPIRIN) ASPIRIN 81 mg
Inactive Ingredients
Ingredient Name Strength
BUTYLATED HYDROXYTOLUENE  
DEXTRATES  
FD&C YELLOW NO. 6  
CELLULOSE, MICROCRYSTALLINE  
MODIFIED CORN STARCH (1-OCTENYL SUCCINIC ANHYDRIDE)  
STARCH, CORN  
SACCHARIN SODIUM DIHYDRATE  
STEARIC ACID  
ORANGE  
Product Characteristics
Color ORANGE Score no score
Shape ROUND Size 8mm
Flavor Imprint Code UPPER;tcl334;LOWER;PLAIN
Contains     
Packaging
# NDC Package Description Multilevel Packaging
1 0904-6288-89 90 TABLET In 1 BOTTLE None

Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
OTC MONOGRAPH FINAL part343 07/16/2010

Labeler - Major Pharmaceuticals (191427277)
Revised: 05/2012Major Pharmaceuticals