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
Drug Label Information
Updated January 1, 2025
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- Drug Facts
- Active ingredients (in each tablet)
- Purposes
- 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 doctorAsk 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 weeksStop 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.
If pregnant or breast-feeding, ask a health professional before use.
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Directions
• 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
- Questions?
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SPL UNCLASSIFIED SECTION
+TopCare® health
COMPARE TO COLACE® 2-IN-1 ACTIVE INGREDIENTS*
Stool Softener + Stimulant Laxative
For Relief Of Occasional Constipation:
• Effective
• Reliable
• ComfortableDISTRIBUTED BY TOPCO ASSOCIATES LLC
ELK GROVE VILLAGE, IL 60007
©TOPCO STVA1120
topcare@topco.com
www.topcarebrand.com
*This product is not manufactured or distributed by Purdue Products L.P., distributor of Colace® 2-IN-1.
TAMPER EVIDENT: DO NOT USE IF PRINTED SAFETY SEAL UNDER CAP IS BROKEN OR MISSING
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- Packaging
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INGREDIENTS AND APPEARANCE
LAXATIVE DOCUSATE SODIUM WITH SENNA
docusate sodium and sennosides tablet, coatedProduct 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 ALUMINUM LAKE (UNII: 6T47AS764T) 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 Drug M007 05/01/2021 Labeler - TOPCO ASSOCIATES LLC (006935977)
