Label: STOOL SOFTENER WITH STIMULANT LAXATIVE- docusate sodium and sennosides tablet
- NDC Code(s): 63941-829-10
- Packager: Best Choice (Valu Merchandisers Company)
- 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 October 11, 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 directed by a doctor
- if you are now 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
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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?
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Principal Display Panel
COMPARE TO THE ACTIVE INGREDIENTS IN COLACE® 2-IN1†
Stool Softener
Plus Stimulant Laxative
Docusate Sodium, 50 mg &
Sennosides, 8.6 mg
For Overnight Relief of Occasional Constipation
- Effective
- Reliable
- Comfortable
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 Colace® 2-IN-1.
PROUDLY DISTRIBUTED BY:
VALU MERCHANDISERS, CO.
5000 KANSAS AVE
KANSAS CITY, KS 66106
- 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:63941-829 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:63941-829-10 1 in 1 BOX 12/31/2018 12/27/2024 1 100 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 12/31/2018 12/27/2024 Labeler - Best Choice (Valu Merchandisers Company) (868703513)