Aspirin

Generic Name: acetylsalicylic acid

Dosage Form: tablet, film coated
Aspirin 325 MG TABLETS

Drug Facts

Active ingredient (in each tablet)

Aspirin 325 mg

Purposes

Pain reliever/fever reducer

Uses

temporarily relieves

• headache


• muscle pain


• toothache


• menstrual pain


• pain and fever of colds


• minor pain of arthritis

Warnings

Reye's syndrome

Children and teenagers should not use this medicine for chicken pox or flu symptoms before a doctor is consulted about Reye's syndrome, a rare but serious illness reported to be associated with Aspirin.

Allergy alert

Aspirin may cause a severe allergic reaction which may include:

• hives


• facial swelling


• asthma (wheezing)


• shock

Alcohol warning

If you consume 3 or more alcoholic drinks every day, ask your doctor whether you should take Aspirin or other pain relievers/fever reducers. Aspirin may cause stomach bleeding.

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

Ask a doctor before use if you have

• stomach problems (such as heartburn, upset stomach, or stomach pain) that last or come back


• bleeding problems


• ulcers


• asthma

Ask a doctor or pharmacist before use if you are taking a prescription drug for

• anticoagulation (blood thinning)


• gout


• diabetes


• arthritis

Stop use and ask a doctor if

• an allergic reaction occurs. Seek medical help right away.


• pain gets worse or lasts more than 10 days


• redness or swelling is present


• fever lasts more than 3 days


• new symptoms occur


• 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.

Keep out of reach of children. 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: take 1 or 2 tablets every 4 hours or 3 tablets every 6 hours, not to exceed 12 tablets in 24 hours


• children under 12 years: consult a doctor

Other information

• save carton for full directions and warnings


• store at room temperature

Inactive ingredients

carnauba wax1, corn starch, hypromellose, powdered cellulose, triacetin

1

may contain this ingredient

PRINCIPAL DISPLAY PANEL

Aspirin 325 MG TABLETS

Each Film coated Tablet Contains:

Aspirin 325 MG

Lot No :

MFG. DATE :

Exp. Date :

Jar No. :

Quantity : 50,000 Tablets

NDC. No : 65437-038-05

WARNING :

KEEP OUT OF THE REACH OF CHILDREN

STORE CONTROLLED ROOM TEMPERATURE OF 59° –86°F (15° – 30°C)

PROTECT FROM LIGHT, MOISTURE AND FREEZING

THIS IS A BULK SHIPMENT INTENDED FOR FURTHER PROCESSING ONLY.

CONTENTS SHOULD BE APPROVED,REPACKAGED IMMEDIATELY AND LABELED IN STRICT

CONFORMANCE WITH THE FDA AND REGULATIONS THEREUNDER

MANUFACTURED BY:

MANUFACTURED CODE No Guj/Drugs/G/1362

LABELER CODE # 14803

MANUFACTURED FOR:

HIMPRIT PHARMACHEM PVT. LTD

"LAKULISH", R.V.DESAI ROAD,

NEXT TO NAVAPURA POLICE STATION

BARODA, INDIA – 390 001

CAUTION : "FOR MANUFACTURING, PROCESSING OR REPACKING"

Aspirin  Aspirin  tablet, film coated

Product Information Product Type HUMAN OTC DRUG NDC Product Code (Source) 65437-038 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 STARCH, CORN   SILICON DIOXIDE   ANHYDROUS DIBASIC CALCIUM PHOSPHATE   CROSCARMELLOSE SODIUM   TALC   POLYETHYLENE GLYCOL   POLYVINYL ALCOHOL   TITANIUM DIOXIDE   WATER

Product Characteristics Color WHITE Score no score Shape ROUND Size 9mm Flavor Imprint Code Contains

Packaging # NDC Package Description Multilevel Packaging 1 65437-038-05 1 BAG In 1 DRUM contains a BAG 1 50000 TABLET In 1 BAG This package is contained within the DRUM (65437-038-05) 2 65437-038-07 1 BAG In 1 DRUM contains a BAG 2 75000 TABLET In 1 BAG This package is contained within the DRUM (65437-038-07) 3 65437-038-10 1 BAG In 1 DRUM contains a BAG 3 100000 TABLET In 1 BAG This package is contained within the DRUM (65437-038-10)

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC MONOGRAPH FINAL	part341	03/01/2010

Labeler - HIMPRIT PHARMACHEM PVT LTD (917261992)

Revised: 02/2010HIMPRIT PHARMACHEM PVT LTD

More Aspirin resources

• Aspirin Side Effects (in more detail)
• Aspirin Dosage
• Aspirin Use in Pregnancy & Breastfeeding
• Drug Images
• Aspirin Drug Interactions
• Aspirin Support Group
• 11 Reviews for Aspirin - Add your own review/rating

• Aspirin Monograph (AHFS DI)


• Aspirin MedFacts Consumer Leaflet (Wolters Kluwer)


• Aspirin rectal Concise Consumer Information (Cerner Multum)


• aspirin Concise Consumer Information (Cerner Multum)


• Bayer Low Strength Delayed-Release Tablets MedFacts Consumer Leaflet (Wolters Kluwer)


• Ecotrin Advanced Consumer (Micromedex) - Includes Dosage Information


• Empirin Concise Consumer Information (Cerner Multum)


• ZORprin Controlled-Release Tablets MedFacts Consumer Leaflet (Wolters Kluwer)

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