Label: SENNA LEAF AND DOCUSATE SODIUM tablet, film coated
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Contains inactivated NDC Code(s)
NDC Code(s): 65437-035-50, 65437-035-70 - Packager: HIMPRIT PHARMACHEM PVT LTD
- Category: HUMAN OTC DRUG LABEL
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 March 5, 2010
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- Official Label (Printer Friendly)
- SPL UNCLASSIFIED SECTION
- ACTIVE INGREDIENT
- Uses
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Warnings
Do not use
- if you are now taking mineral oil, unless directed by a doctor
- laxative products for longer than 1 week unless directed by a doctor
Ask a doctor before use if you have
- stomach pain
- nausea
- vomiting
- noticed a sudden change in bowel habits that continues over a period of 2 weeks
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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 - Inactive Ingredients
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PRINCIPAL DISPLAY PANEL - Shipping Label
SENNA 8.6mg & DOCUSATE SODIUM 50mg
Orange Tablets
Each Tablet Contains:
CALCIUM SENNOSIDES 8.6mg
DOCUSATE SODIUM 50mgLot No: Quantity: Mfg Date: Jar No: Exp Date: NDC NO: 65437-035-50 WARNING:
KEEP OUT OF THE REACH OF CHILDRENSTORE AT CONTROLLED ROOM TEMPERATURE OF 59 - 77 F (15 - 25 C)
PROTECT FROM LIGHT,MOISURE 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 F.D. & C. ACT AND REGULATIONS THEREUNDER.MANUFACTURED BY:
MANUFACTURED CODE NO Guj/Drugs/G/1362
LABELLER CODE # 14803MANUFACTURED FOR:
HIMPRIT PHARMACHEM PVT.LTD.
"LAKULISH" R.V.DESAI ROAD
NEXT TO NAVAPURA POLICE STATION
BARODA, INDIA 390 001 -
INGREDIENTS AND APPEARANCE
SENNA LEAF AND DOCUSATE SODIUM
senna leaf and docusate sodium tablet, film coatedProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:65437-035 Route of Administration ORAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength SENNA LEAF (UNII: AK7JF626KX) (SENNA LEAF - UNII:AK7JF626KX) SENNA LEAF 8.6 mg DOCUSATE SODIUM (UNII: F05Q2T2JA0) (DOCUSATE - UNII:M7P27195AG) DOCUSATE SODIUM 50 mg Inactive Ingredients Ingredient Name Strength MALTODEXTRIN (UNII: 7CVR7L4A2D) CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U) ANHYDROUS DIBASIC CALCIUM PHOSPHATE (UNII: L11K75P92J) CROSCARMELLOSE SODIUM (UNII: M28OL1HH48) STEARIC ACID (UNII: 4ELV7Z65AP) POLYETHYLENE GLYCOL (UNII: 3WJQ0SDW1A) D&C YELLOW NO. 10 (UNII: 35SW5USQ3G) TITANIUM DIOXIDE (UNII: 15FIX9V2JP) WATER (UNII: 059QF0KO0R) SILICON DIOXIDE (UNII: ETJ7Z6XBU4) MAGNESIUM STEARATE (UNII: 70097M6I30) HYPROMELLOSE (UNII: 3NXW29V3WO) CARNAUBA WAX (UNII: R12CBM0EIZ) Product Characteristics Color ORANGE Score no score Shape ROUND Size 9mm Flavor Imprint Code Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:65437-035-50 1 in 1 DRUM 1 50000 in 1 BAG 2 NDC:65437-035-70 1 in 1 DRUM 2 75000 in 1 BAG Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC MONOGRAPH NOT FINAL part334 04/01/2010 Labeler - HIMPRIT PHARMACHEM PVT LTD (917261992)