Label: SENNA tablet, film coated
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Contains inactivated NDC Code(s)
NDC Code(s): 65437-087-50 - 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.
Drug Label Information
Updated November 11, 2009
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- Official Label (Printer Friendly)
- SPL UNCLASSIFIED SECTION
- Active ingredient (in each tablet)
- Purpose
- Uses
- Warnings
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Directions
- take preferably at bedtime or as directed by a doctor
age starting dosage maximum dosage adults and children 12 years of age or older 2 tablets once a day 4 tablets twice a day children 6 to under 12 years 1 tablet once a day 2 tablets twice a day children 2 to under 6 years 1/2 tablet once a day 1 tablet twice a day children under 2 years ask a doctor ask a doctor - Other information
- Inactive ingredients
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PRINCIPAL DISPLAY PANEL - Shipping Label
Each Film Coated Tablet Contains :
CALCIUM SENNOSIDES 8.6mgLot No. :
Mfg. Date :
Exp. Date :
Jar No. :
Quantity : 50,000 Tablets
NDC No : 65437 - 087 - 50WARNING :
KEEP OUT OF THE REACH OF CHILDRENSTORE AT CONTROLLED ROOM TEMPERATURE OF 59°-77°F (15°-25° 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 :
MANUFACTURER CODE No.: Guj/Drugs/G/1362
LABELER CODE # 14803Manufactured For.
HIMPRIT PHARMACHEM PVT. LTD.
"LAKULESH", R.V. DESAI ROAD,
NEXT TO NAVAPURA POLICE STATION,
BARODA, INDIA - 390 001CAUTION : "FOR MANUFACTURING, PROCESSING OR REPACKING"
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INGREDIENTS AND APPEARANCE
SENNA
senna tablet, film coatedProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:65437-087 Route of Administration ORAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength SENNA (UNII: AK7JF626KX) (SENNA - UNII:AK7JF626KX) SENNA 8.6 mg Inactive Ingredients Ingredient Name Strength MALTODEXTRIN (UNII: 7CVR7L4A2D) CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U) CROSCARMELLOSE SODIUM (UNII: M28OL1HH48) STEARIC ACID (UNII: 4ELV7Z65AP) SILICON DIOXIDE (UNII: ETJ7Z6XBU4) MAGNESIUM STEARATE (UNII: 70097M6I30) HYPROMELLOSE (UNII: 3NXW29V3WO) MINERAL OIL (UNII: T5L8T28FGP) WATER (UNII: 059QF0KO0R) Product Characteristics Color BROWN Score no score Shape ROUND Size 10mm Flavor Imprint Code S8 Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:65437-087-50 1 in 1 DRUM 1 50000 in 1 BAG Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC MONOGRAPH FINAL part334 11/20/2009 Labeler - HIMPRIT PHARMACHEM PVT LTD (917261992) Registrant - SPIRIT PHARMACEUTICALS,LLC (179621011) Establishment Name Address ID/FEI Business Operations ELYSIUM PHARMACEUTICALS LTD 858352983 MANUFACTURE