Label: DOCUSATE SODIUM capsule
- NDC Code(s): 50804-862-25
- Packager: Good Sense (Geiss, Destin & Dunn, Inc.)
- 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 November 7, 2022
If you are a consumer or patient please visit this version.
- Download DRUG LABEL INFO: PDF XML
- Official Label (Printer Friendly)
- Active ingredient (in each softgel)
- Purpose
- Uses
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Warnings
Ask a doctor before use if you have
- stomach pain
- nausea
- vomiting
- noticed a sudden change in bowel habits that last over 2 weeks
- Directions
- Other information
- Inactive ingredients
- Questions or comments?
-
Principal Display Panel
†Compare to the active ingredient in Dulcolax® Stool Softener
Gentle
Stool Softener
Docusate Sodium
Stool Softener Laxative
For Gentle Softener Relief
Stimulant-free
Softgels
†This product is not manufactured or distributed by Chattem, Inc., distributor of Dulcolax
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: Perrigo Direct, Inc.
Peachtree City, GA 30269
- Product Label
-
INGREDIENTS AND APPEARANCE
DOCUSATE SODIUM
docusate sodium capsuleProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:50804-862 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 RED NO. 40 (UNII: WZB9127XOA) FD&C YELLOW NO. 6 (UNII: H77VEI93A8) GELATIN (UNII: 2G86QN327L) SORBITAN (UNII: 6O92ICV9RU) POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A) PROPYLENE GLYCOL (UNII: 6DC9Q167V3) WATER (UNII: 059QF0KO0R) SORBITOL (UNII: 506T60A25R) GLYCERIN (UNII: PDC6A3C0OX) MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U) Product Characteristics Color orange Score no score Shape OVAL Size 12mm Flavor Imprint Code P51 Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:50804-862-25 25 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product 05/28/2021 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph not final part334 05/28/2021 Labeler - Good Sense (Geiss, Destin & Dunn, Inc.) (076059836)