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ASPIRIN by HIMPRIT PHARMACHEM PVT LTD

Dosage form: tablet, film coated
Ingredients: ASPIRIN 325mg
Labeler: HIMPRIT PHARMACHEM PVT LTD
NDC Code: 65437-038

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

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 wax, corn starch, hypromellose, powdered cellulose, triacetin


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 TypeHUMAN OTC DRUGItem Code (Source)NDC:65437-038
Route of AdministrationORALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ASPIRIN (ASPIRIN) ASPIRIN325 mg
Inactive Ingredients
Ingredient NameStrength
STARCH, CORN 
SILICON DIOXIDE 
ANHYDROUS DIBASIC CALCIUM PHOSPHATE 
CROSCARMELLOSE SODIUM 
TALC 
POLYETHYLENE GLYCOL 
POLYVINYL ALCOHOL 
TITANIUM DIOXIDE 
WATER 
Product Characteristics
ColorWHITEScoreno score
ShapeROUNDSize9mm
FlavorImprint Code
Contains    
Packaging
#Item CodePackage Description
1NDC:65437-038-051 BAG (BAG) in 1 DRUM
150000 TABLET, FILM COATED (TABLET) in 1 BAG
2NDC:65437-038-071 BAG (BAG) in 1 DRUM
275000 TABLET, FILM COATED (TABLET) in 1 BAG
3NDC:65437-038-101 BAG (BAG) in 1 DRUM
3100000 TABLET, FILM COATED (TABLET) in 1 BAG
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC MONOGRAPH FINALpart34103/01/2010
Labeler - HIMPRIT PHARMACHEM PVT LTD (917261992)

 
HIMPRIT PHARMACHEM PVT LTD

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Medically reviewed on Feb 8, 2018

Further information

Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.

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