Label: STOOL SOFTENER- docusate sodium capsule, liquid filled
- NDC Code(s): 21130-578-60
- Packager: Safeway, Inc.
- 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 9, 2022
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- Download DRUG LABEL INFO: PDF XML
- Official Label (Printer Friendly)
- Active Ingredient (in each softgel)
- Purpose
- Uses
-
Warnings
Ask a doctor before use if you have
- stomach pain
- nausea
- vomiting
- noticed a sudden change in bowel habits that lasts over 2 weeks
- Directions
- Other information
- Inactive Ingredients
-
Principal Display Panel
Compare to Colace® Regular Strength Stool Softener active ingredient
STOOL SOFTENER
DOCUSATE SODIUM 100 mg in each Softgel
Stool Softener Laxative
- Gentle
- Dependable
- Stimulant-free
SOFTGELS
†This product is not manufactured or distributed by Purdue Product L.P., distributor of Colace® Regular Strength Stool Softener.
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
BETTER LIVING BRANDS LLC
P.O. BOX 99
PLEASANTON, CA 94566-0009
- Product Label
-
INGREDIENTS AND APPEARANCE
STOOL SOFTENER
docusate sodium capsule, liquid filledProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:21130-578 Route of Administration ORAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength DOCUSATE SODIUM (UNII: F05Q2T2JA0) (DOCUSATE - UNII:M7P27195AG) DOCUSATE SODIUM 100 mg Inactive Ingredients Ingredient Name Strength FD&C BLUE NO. 1 (UNII: H3R47K3TBD) FD&C RED NO. 40 (UNII: WZB9127XOA) FD&C YELLOW NO. 6 (UNII: H77VEI93A8) GELATIN (UNII: 2G86QN327L) GLYCERIN (UNII: PDC6A3C0OX) POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A) PROPYLENE GLYCOL (UNII: 6DC9Q167V3) WATER (UNII: 059QF0KO0R) SORBITAN (UNII: 6O92ICV9RU) SORBITOL (UNII: 506T60A25R) TITANIUM DIOXIDE (UNII: 15FIX9V2JP) D&C RED NO. 33 (UNII: 9DBA0SBB0L) Product Characteristics Color red, white Score no score Shape OVAL Size 12mm Flavor Imprint Code P10;SCU2;D1 Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:21130-578-60 1 in 1 BOX 07/08/2013 02/28/2025 1 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 07/08/2013 02/28/2025 Labeler - Safeway, Inc. (009137209)