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Aspirin

NCS HealthCare of KY, Inc dba Vangard Labs

Aspirin 325mg


FULL PRESCRIBING INFORMATION: CONTENTS*




FULL PRESCRIBING INFORMATION

Aspirin 325mg (NSAID*)

*nonsteriodal anti-flammatory drug

Pain Reliever/Fever Reducer

temporarily relieves

• headache

• toothache

• minor pain of arthritis

• muscle pain

• pain and fever of colds

• menstrual pain

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

•  shock

•  asthma(wheezing)

Stomach Bleeding Warning: This product contains an NSAID, which may cause stomach bleeding. The chance is higher if the user:

• is age 60 or older

• has had stomach ulcers or bleeding problems

• takes a blood-thinning (anticoagulant) or steriod drug

• takes other drugs containing prescription or nonprescription NSAIDS (aspirin,Ibuprofen, naproxen, or others)

• takes more or for a longer time than directed

• has 3 or more alcoholic drinks every day while using this product

if you have ever had an allergic reaction to any other pain reliever/fever reducer.

• stomach bleeding warning applies to user

• user has a history of stomach problems, such as heartburn

• user has high blood pressure, heart disease, liver cirrhosis, or kidney disease

• user is taking a diuretic

• user has asthma

• user has not been drinking fluids

• user has lost a lot of fluid due to vomiting or diarrhea

• taking a prescription drug for diabetes, or gout or arthritis

• taking any other drug

• under a doctor's care for any serious condition

• user experiences any ot the following signs of stomach bleeding:

  °feels faint

   °has bloody or black stools

   °vomits blood

    °has 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 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.

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

Directions

DRINK A FULL GLASS OF WATER WITH EACH DOSE.

adults and children 12 years and over: 1 or 2 tablets every 4 hours while symptoms last, not more than 12 tablets in 24 hours.

Children under 12 years: ask a doctor

• Store at 20'- 25' C (68 - 77'F) 

• coated for easier swallowing

Corn Starch, Croscarmellose sodium, hypromellose, microcrystalline cellulose, mineral oil, titanium dioxide.

Call 1-800-645-2158, 9am - 5pm ET, Monday - Friday

Principal Display Panel

Aspirin

Aspirin

Aspirin TABLET, COATED

Product Information

Product Type Human otc drug label Item Code (Source) NDC:0615-0522(NDC:0536-3305)
Route of Administration ORAL DEA Schedule

Active Ingredient/Active Moiety

Ingredient Name Basis of Strength Strength
aspirin ASPIRIN 325 mg

Inactive Ingredients

Ingredient Name Strength
STARCH, CORN
CROSCARMELLOSE SODIUM
HYPROMELLOSES
cellulose, microcrystalline
Mineral Oil
titanium dioxide

Product Characteristics

Color Size Imprint Code Shape
WHITE 10 mm TCL;011 ROUND

Packaging

# Item Code Package Description Marketing Start Date Marketing End Date
1 NDC:0615-0522-31 31 in 1 BLISTER PACK
2 NDC:0615-0522-39 30 in 1 BLISTER PACK

Marketing Information

Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
part part343 2009-09-30


PLEASE, BE CAREFUL!
Be sure to consult your doctor before taking any medication!
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