Label: VEGETABLE LAXATIVE AND STOOL SOFTNER- docusate sodium and sennosides tablet, coated
- NDC Code(s): 36800-938-60
- 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 17, 2023
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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 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 ½ tablet once a day 1 tablet twice a day children under 2 years ask a doctor ask a doctor - Other information
- Inactive ingredients
- Questions?
- PRINCIPAL DISPLAY PANEL - 60 Tablet Bottle Carton
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INGREDIENTS AND APPEARANCE
VEGETABLE LAXATIVE AND STOOL SOFTNER
docusate sodium and sennosides tablet, coatedProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:36800-938 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 Yellow No. 6 (UNII: H77VEI93A8) 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 ORANGE Score no score Shape ROUND Size 10mm Flavor Imprint Code S153 Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:36800-938-60 1 in 1 CARTON 05/01/2021 1 60 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)