Label: STOOL SOFTENER LAXATIVE- docusate sodium and sennosides tablet
- NDC Code(s): 0363-8780-20, 0363-8780-60
- Packager: Walgreens
- Category: HUMAN OTC DRUG LABEL
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 30, 2022
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- Official Label (Printer Friendly)
- Active ingredients (in each tablet)
- Purpose
- Uses
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Warnings
Do not use
- laxative products for longer than 1 week unless told to do so by a doctor
- if you are presently taking mineral oil, unless told to do so by a doctor
Ask a doctor before use if you have
- stomach pain
- nausea
- vomiting
- noticed a sudden change in bowel habits that lasts over a period of 2 weeks
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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 older 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 ask a doctor
- Other information
- Inactive ingredients
- Questions or comments?
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Principal Display Panel
Compare to the active ingredients in Colace® 2-IN-1††
Stool Softener + Stimulant Laxative
DOCUSATE SODIUM 50 mg / STOOL SOFTENER
SENNOSIDES 8.6 mg / STIMULANT LAXATIVE
GENTLE DEPENDABLE
- Relief in 6 to 12 hours
- 2-in1
TABLETS
††This product is not manufactured of distributed by Avrio Health L.P., owner of the registered trademark Colace® 2-IN-1.
TAMPER EVIDENT: DO NOT USE IF PRINTED SAFETY SEAL UNDER CAP IS BROKEN OR MISSING
KEEP OUTER CARTON FOR COMPLETE WARNINGS AND PRODUCT INFORMATION
DISTRIBUTED BY: WALGREENS CO,
200 WILMOT RD., DEERFIELD, IL 60015
walgreens.com
- Product Label
-
INGREDIENTS AND APPEARANCE
STOOL SOFTENER LAXATIVE
docusate sodium and sennosides tabletProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:0363-8780 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 CARNAUBA WAX (UNII: R12CBM0EIZ) CROSCARMELLOSE SODIUM (UNII: M28OL1HH48) DIBASIC CALCIUM PHOSPHATE DIHYDRATE (UNII: O7TSZ97GEP) FD&C RED NO. 40 (UNII: WZB9127XOA) HYPROMELLOSES (UNII: 3NXW29V3WO) MAGNESIUM STEARATE (UNII: 70097M6I30) CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U) POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A) SILICON DIOXIDE (UNII: ETJ7Z6XBU4) SODIUM BENZOATE (UNII: OJ245FE5EU) STEARIC ACID (UNII: 4ELV7Z65AP) TITANIUM DIOXIDE (UNII: 15FIX9V2JP) ALUMINUM OXIDE (UNII: LMI26O6933) Product Characteristics Color red Score no score Shape ROUND Size 10mm Flavor Imprint Code TCL097 Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:0363-8780-20 200 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product 07/30/2020 2 NDC:0363-8780-60 1 in 1 BOX 07/30/2020 2 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 07/30/2020 Labeler - Walgreens (008965063)