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Generic Name: acetylsalicylic acid
Dosage Form: tablet, film coated

Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

Aspirin 325 MG TABLETS

Drug Facts

Active ingredient (in each tablet)

Aspirin 325 mg

Slideshow: View Frightful (But Dead Serious) Drug Side Effects

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 Item Code (Source) NDC: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
# Item Code Package Description
1 NDC:65437-038-05 1 BAG (BAG) in 1 DRUM
1 50000 TABLET, FILM COATED (TABLET) in 1 BAG
2 NDC:65437-038-07 1 BAG (BAG) in 1 DRUM
2 75000 TABLET, FILM COATED (TABLET) in 1 BAG
3 NDC:65437-038-10 1 BAG (BAG) in 1 DRUM
3 100000 TABLET, FILM COATED (TABLET) in 1 BAG
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: 02/2010
 
HIMPRIT PHARMACHEM PVT LTD



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