Label: ASPIRIN- aspirin tablet, film coated
- NDC Code(s): 65437-038-05, 65437-038-07, 65437-038-10
- Packager: HIMPRIT PHARMACHEM PVT LTD
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: OTC monograph final
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.
Updated February 8, 2010
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- SPL UNCLASSIFIED SECTION
- Active ingredient (in each tablet)
Aspirin 325 mgClose
Pain reliever/fever reducerClose
- muscle pain
- menstrual pain
- pain and fever of colds
- minor pain of arthritis
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.
Aspirin may cause a severe allergic reaction which may include:
- facial swelling
- asthma (wheezing)
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.
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
Ask a doctor or pharmacist before use if you are taking a prescription drug for
- anticoagulation (blood thinning)
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.
- 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
- 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
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 CODE No Guj/Drugs/G/1362
LABELER CODE # 14803
HIMPRIT PHARMACHEM PVT. LTD
"LAKULISH", R.V.DESAI ROAD,
NEXT TO NAVAPURA POLICE STATION
BARODA, INDIA – 390 001
CAUTION : "FOR MANUFACTURING, PROCESSING OR REPACKING"
- INGREDIENTS AND APPEARANCE
aspirin tablet, film coated
Product Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:65437-038 Route of Administration ORAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength ASPIRIN (UNII: R16CO5Y76E) (ASPIRIN - UNII:R16CO5Y76E) ASPIRIN 325 mg Inactive Ingredients Ingredient Name Strength STARCH, CORN (UNII: O8232NY3SJ) SILICON DIOXIDE (UNII: ETJ7Z6XBU4) ANHYDROUS DIBASIC CALCIUM PHOSPHATE (UNII: L11K75P92J) CROSCARMELLOSE SODIUM (UNII: M28OL1HH48) TALC (UNII: 7SEV7J4R1U) POLYETHYLENE GLYCOL (UNII: 3WJQ0SDW1A) POLYVINYL ALCOHOL (UNII: 532B59J990) TITANIUM DIOXIDE (UNII: 15FIX9V2JP) WATER (UNII: 059QF0KO0R) Product Characteristics Color WHITE Score no score Shape ROUND Size 9mm Flavor Imprint Code Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:65437-038-05 1 in 1 DRUM 1 50000 in 1 BAG 2 NDC:65437-038-07 1 in 1 DRUM 2 75000 in 1 BAG 3 NDC:65437-038-10 1 in 1 DRUM 3 100000 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)