DrugCite

ASPIRIN - aspirin tablet 
Rebel Distributors Corp

Aspirin Drug Facts

Active ingredient

Aspirin 325mg

Purpose

Pain Reliever

Keep Out of Reach of Children

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

Uses

For the temporary relief of minor aches and pains. Ask your doctor about other uses for aspirin.

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 or 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) or 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.

Do not use if you are allergic to aspirin or any other pain reliever/fever reducer.

Ask a doctor before use if ° the stomach bleeding warning applies to you ° you are taking a diuretic ° you have a history of stomach problems such as heartburn ° you have high blood pressure, heart disease, liver cirrhosis, kidney disease or asthma.

Ask a doctor or pharmacist before use if you are ° taking any other drug containing an NSAID (prescription or nonprescription) ° taking a blood thinning (anticoagulant) or steroid drug ° taking a prescription drug for diabetes, gout or arthritis.

Stop use and ask a doctor if ° 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, an allergic reaction occurs. Seek medical help right away if pain gets worse or lasts more than 10 days, redness or swelling is present, fever gets worse or lasts more than 3 days, any new symptoms occur, or ringing in the ears or loss of hearing occurs.

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. Swallow whole; do not chew or crush. Do not exceed recommend dose.

Adults and children 12 years and older: take 1-2 tablets every 4 hours, as needed, not more than 12 tablets in 24 hours, or as directed by a doctor.

Children under 12: ask a doctor.

Other Information

Store at room temperature, 15°C - 30°C (59°F - 86°F).

For institutional use only.

Inactive ingredients

May contain acetylated monoglycerides, cellulose, croscarmellose sodium, D&C yellow no. 10, FD&C yellow no. 6, hypromellose, hypromellose phthalate, iron oxide, methacrylic acid, mineral oil, PEG, polydextrose, polysorbate 80, polyvinyl acetate phthalate, propylene glycol, silica sodium alginate, sodium bicarbonate, sodium lauryl sulfate, starch stearic acid, talc, titanium dioxide, triacetin, triethyl citrate, wax.

Package/Label Principal Display Panel

Aspirin EC 325mg


ASPIRIN 
aspirin  tablet
Product Information
Product Type HUMAN OTC DRUG NDC Product Code (Source) 21695-666 (57896-401)
Route of Administration ORAL DEA Schedule     
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
ASPIRIN (ASPIRIN) ASPIRIN 325 mg
Inactive Ingredients
Ingredient Name Strength
CELLULOSE ACETATE  
CROSCARMELLOSE SODIUM  
D&C YELLOW NO. 10  
FD&C YELLOW NO. 6  
HYPROMELLOSES  
HYPROMELLOSE PHTHALATE (24% PHTHALATE, 55 CST)  
FERRIC OXIDE RED  
METHACRYLIC ACID  
MINERAL OIL  
POLYDEXTROSE  
POLYSORBATE 80  
PROPYLENE GLYCOL  
SODIUM ALGINATE  
SODIUM BICARBONATE  
SODIUM LAURYL SULFATE  
STEARIC ACID  
TALC  
TITANIUM DIOXIDE  
TRIACETIN  
TRIETHYL CITRATE  
WHITE WAX  
Product Characteristics
Color ORANGE Score no score
Shape ROUND Size 12mm
Flavor Imprint Code T
Contains     
Packaging
# NDC Package Description Multilevel Packaging
1 21695-666-30 30 TABLET In 1 BOTTLE None
2 21695-666-90 90 TABLET In 1 BOTTLE None
3 21695-666-00 100 TABLET In 1 BOTTLE None

Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
OTC monograph final part343 11/07/2008

Labeler - Rebel Distributors Corp (118802834)
Establishment
Name Address ID/FEI Operations
Rebel Distributors Corp 118802834 RELABEL, REPACK
Revised: 02/2011Rebel Distributors Corp