Label: SENNA S- docusate sodium, sennosides tablet
- NDC Code(s): 36800-783-12, 36800-783-60
- Packager: TOP CARE (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 November 28, 2022
If you are a consumer or patient please visit this version.
- Download DRUG LABEL INFO: PDF XML
- Official Label (Printer Friendly)
- Active ingredients (in each tablet)
- Purpose
- 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 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?
-
Principal Display Panel
COMPARE TO SENOKOT-S® ACTIVE INGREDIENTS†
Vegetable Laxative
+ Stool Softener
DOCUSATE SODIUM 50 mg • STOOL SOFTENER
SENNOSIDES 8.6 MG • LAXATIVE
TABLETS
TAMPER EVIDENT: DO NOT USE IF PRINTED SAFETY SEAL UNDER CAP IS BROKEN OR MISSING.
KEEP OUTER CARTON FOR COMPLETE WARNINGS AND PRODUCT INFORMATION.
†This product is not manufactured or distributed by Avrio Health L.P., distributor of Senokot-S®.
DISTRIBUTED BY TOPCO ASSOCIATES LLC
ELK GROVE VILLAGE, IL 60007
- Product Labeling
-
INGREDIENTS AND APPEARANCE
SENNA S
docusate sodium, sennosides tabletProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:36800-783 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 CROSCARMELLOSE SODIUM (UNII: M28OL1HH48) DIBASIC CALCIUM PHOSPHATE DIHYDRATE (UNII: O7TSZ97GEP) FD&C YELLOW NO. 6 (UNII: H77VEI93A8) HYPROMELLOSES (UNII: 3NXW29V3WO) MAGNESIUM STEARATE (UNII: 70097M6I30) CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U) POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A) SILICON DIOXIDE (UNII: ETJ7Z6XBU4) TALC (UNII: 7SEV7J4R1U) TITANIUM DIOXIDE (UNII: 15FIX9V2JP) ALUMINUM OXIDE (UNII: LMI26O6933) Product Characteristics Color orange Score no score Shape ROUND Size 10mm Flavor Imprint Code PSD22 Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:36800-783-60 1 in 1 BOX 07/31/2019 1 60 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product 2 NDC:36800-783-12 1 in 1 BOX 07/31/2019 2 120 in 1 BOTTLE, PLASTIC; 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 07/31/2019 Labeler - TOP CARE (Topco Associates LLC) (006935977)