Label: LAXATIVE SENNA- sennosides tablet, coated
- NDC Code(s): 36800-984-01
- Packager: TOPCO ASSOCIATES LLC
- 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 January 13, 2023
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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 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 tablet once a day 1 tablet twice a day children under 2 years ask a doctor ask a doctor - Other information
- Inactive ingredients
- Questions or comments
- SPL UNCLASSIFIED SECTION
- PRINCIPAL DISPLAY PANEL - 100 mg Tablet Bottle Carton
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INGREDIENTS AND APPEARANCE
LAXATIVE SENNA
sennosides tablet, coatedProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:36800-984 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) ANHYDROUS DIBASIC CALCIUM PHOSPHATE (UNII: L11K75P92J) HYPROMELLOSE, UNSPECIFIED (UNII: 3NXW29V3WO) Magnesium Stearate (UNII: 70097M6I30) Microcrystalline Cellulose (UNII: OP1R32D61U) Silicon Dioxide (UNII: ETJ7Z6XBU4) Talc (UNII: 7SEV7J4R1U) Triacetin (UNII: XHX3C3X673) Product Characteristics Color BROWN Score no score Shape ROUND Size 9mm Flavor Imprint Code S155 Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:36800-984-01 1 in 1 CARTON 05/01/2021 1 100 in 1 BOTTLE; Type 0: Not a Combination Product Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC MONOGRAPH NOT FINAL part334 05/01/2021 Labeler - TOPCO ASSOCIATES LLC (006935977)