Label: STOOL SOFTENER WITH STIMULANT LAXATIVE- docusate sodium and sennosides tablet
- NDC Code(s): 69842-829-10, 69842-829-25, 69842-829-40
- Packager: CVS Pharmacy
- 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 18, 2023
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
-
Warnings
Do not use
- laxative products for longer than 1 week unless directed by a doctor
- if you are now taking mineral oil, 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 lasts over a period of 2 weeks
-
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
carnauba wax*, croscarmellose sodium, dibasic calcium phosphate dihydrate, FD&C blue #2 aluminum lake, FD&C red #40 aluminum lake, hypromellose, magnesium stearate, microcrystalline cellulose, polyethylene glycol*, silcon dioxide, sodium benzoate*, stearic acid, talc*, titanium dioxide
*contains one or more of these ingredients
- Questions or comments?
-
Principal Display Panel
Compare to the active ingredients in Colace® 2-IN1†
Stool Softener
DOCUSATE SODIUM 50 mg &
SENNOSIDES 8.6 mg
Plus stimulant laxative
Convenient and predictable overnight relief of constipation
TABLETS
TAMPER EVIDENT: DO NOT USE IF PRINTED SAFETY SEAL UNDER CAP IS BROKEN OR MISSING.
†This product is not manufactured or distributed by Avrio Health L.P., distributor of Colace® 2-IN-1.
Distributed by: CVS Pharmacy, Inc.
One CVS Drive, Woonsocket, RI 02895
- Product Label
-
INGREDIENTS AND APPEARANCE
STOOL SOFTENER WITH STIMULANT LAXATIVE
docusate sodium and sennosides tabletProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:69842-829 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) TALC (UNII: 7SEV7J4R1U) TITANIUM DIOXIDE (UNII: 15FIX9V2JP) ALUMINUM OXIDE (UNII: LMI26O6933) FD&C BLUE NO. 2 (UNII: L06K8R7DQK) Product Characteristics Color red Score no score Shape ROUND Size 10mm Flavor Imprint Code TCL097;PSD21;S44 Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:69842-829-10 100 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product 04/30/2019 04/30/2025 2 NDC:69842-829-40 400 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product 04/30/2019 04/30/2025 3 NDC:69842-829-25 250 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product 04/30/2019 04/30/2025 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph not final part334 04/30/2019 04/30/2025 Labeler - CVS Pharmacy (062312574)
