Label: LAXATIVE DOCUSATE SODIUM WITH SENNA- docusate sodium and sennosides tablet, coated
- NDC Code(s): 36800-861-01
- 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.
Updated March 5, 2021
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- SPL UNCLASSIFIED SECTION
- ACTIVE INGREDIENT
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
- noticed a sudden change in bowel habits that continues over a period of 2 weeks
Stop use and ask a doctor if you have rectal bleeding or fail to have a bowel movement after use of a laxative. These may indicate a serious condition.
- take only by mouth. Doses may be taken as a single daily dose, preferably in the evening, or in divided doses.
adults and children 12 years and over take 2-4 tablets daily children 6 to under 12 years of age take 1-2 tablets daily children 2 to under 6 years of age take up to 1 tablet daily children under 2 years ask a doctor
- Other information
- Inactive ingredients
- PRINCIPAL DISPLAY PANEL - 100 Tablet Bottle Carton
INGREDIENTS AND APPEARANCE
LAXATIVE DOCUSATE SODIUM WITH SENNA
docusate sodium and sennosides tablet, coated
Product Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:36800-861 Route of Administration ORAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength Docusate Sodium (UNII: F05Q2T2JA0) (DOCUSATE - UNII:M7P27195AG) Docusate Sodium 50 mg Sennosides (UNII: 3FYP5M0IJX) (Sennosides - UNII:3FYP5M0IJX) Sennosides 8.6 mg Inactive Ingredients Ingredient Name Strength Silicon Dioxide (UNII: ETJ7Z6XBU4) Croscarmellose Sodium (UNII: M28OL1HH48) Anhydrous Dibasic Calcium Phosphate (UNII: L11K75P92J) FD&C Blue No. 2--Aluminum Lake (UNII: 4AQJ3LG584) FD&C Red NO. 40 (UNII: WZB9127XOA) Aluminum Oxide (UNII: LMI26O6933) Hypromellose, Unspecified (UNII: 3NXW29V3WO) Magnesium Stearate (UNII: 70097M6I30) Microcrystalline Cellulose (UNII: OP1R32D61U) Polyethylene Glycol, Unspecified (UNII: 3WJQ0SDW1A) Talc (UNII: 7SEV7J4R1U) Titanium Dioxide (UNII: 15FIX9V2JP) Product Characteristics Color RED Score no score Shape ROUND Size 10mm Flavor Imprint Code S154 Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:36800-861-01 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)