Label: SENNA LAXATIVE- sennosides tablet
- NDC Code(s): 45865-965-30, 45865-965-60
- Packager: medsource pharmaceuticals
- This is a repackaged label.
- Source NDC Code(s): 50804-486
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: OTC monograph not 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 December 30, 2019
If you are a consumer or patient please visit this version.
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- Official Label (Printer Friendly)
- 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 and over 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 tablets once a day 1 tablet twice a day children under 2 years ask a doctor ask a doctor
- Other information
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Inactive Ingredients
croscarmellose sodium, dibasic calcium phosphate dihydrate, hypromellose, liquid paraffin*, magnesium stearate, maltodextrin*, microcrystalline cellulose, mineral oil*, polyethylene glycol*, polyvinyl alcohol*, silicon dioxide*, stearic acid*, sodium lauryl sulfate*, talc
*contains one or more of these ingredients
- Questions or comments?
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Principal Display Panel
Senna Laxative
Standardized Senna Concentrate 8.6 mg
Natural Vegetable Laxative Ingredient
Gentle, overnight relief
†Compare to active ingredients in Senokot®
Tablets
†This product is not manufactured or distributed by Purdue Products L.P., distributor of Senokot®.
TAMPER EVIDENT: DO NOT USE IF PRINTED SAFETY SEAL UNDER CAP IS BROKEN OR MISSING
KEEP OUTER CARTON FOR COMPLETE WARNINGS AND PRODUCT INFORMATION.
Distributed By:
Geiss, Destin & Dunn, Inc.
Peachtree City, GA 30269
- Product Label
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INGREDIENTS AND APPEARANCE
SENNA LAXATIVE
sennosides tabletProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:45865-965(NDC:50804-486) Route of Administration ORAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength SENNOSIDES (UNII: 3FYP5M0IJX) (SENNOSIDES - UNII:3FYP5M0IJX) SENNOSIDES 8.6 mg Inactive Ingredients Ingredient Name Strength CROSCARMELLOSE SODIUM (UNII: M28OL1HH48) DIBASIC CALCIUM PHOSPHATE DIHYDRATE (UNII: O7TSZ97GEP) HYPROMELLOSES (UNII: 3NXW29V3WO) MAGNESIUM STEARATE (UNII: 70097M6I30) MALTODEXTRIN (UNII: 7CVR7L4A2D) CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U) MINERAL OIL (UNII: T5L8T28FGP) SILICON DIOXIDE (UNII: ETJ7Z6XBU4) STEARIC ACID (UNII: 4ELV7Z65AP) TALC (UNII: 7SEV7J4R1U) SODIUM LAURYL SULFATE (UNII: 368GB5141J) POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A) POLYVINYL ALCOHOL, UNSPECIFIED (UNII: 532B59J990) Product Characteristics Color brown Score no score Shape ROUND Size 9mm Flavor Imprint Code 0813;AV;TCL080;S8 Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:45865-965-30 30 in 1 BOTTLE; Type 0: Not a Combination Product 12/11/2019 2 NDC:45865-965-60 60 in 1 BOTTLE; Type 0: Not a Combination Product 12/11/2019 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph not final part334 03/31/2016 Labeler - medsource pharmaceuticals (833685915) Establishment Name Address ID/FEI Business Operations medsource pharmaceuticals 833685915 repack(45865-965)
