Label: STOOL SOFTENER EXTRA STRENGTH- docusate sodium capsule, liquid filled
- NDC Code(s): 59726-258-01
- Packager: P & L Development, LLC
- 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 26, 2021
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- 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 lasts over 2 weeks
- Directions
- Other information
- Inactive ingredients
- Questions or comments?
- Principal Display Panel
- Package Label
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INGREDIENTS AND APPEARANCE
STOOL SOFTENER EXTRA STRENGTH
docusate sodium capsule, liquid filledProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:59726-258 Route of Administration ORAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength DOCUSATE SODIUM (UNII: F05Q2T2JA0) (DOCUSATE - UNII:M7P27195AG) DOCUSATE SODIUM 250 mg Inactive Ingredients Ingredient Name Strength 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) SORBITOL (UNII: 506T60A25R) SORBITAN (UNII: 6O92ICV9RU) Product Characteristics Color orange Score no score Shape CAPSULE Size 20mm Flavor Imprint Code P20;SCU1 Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:59726-258-01 100 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product 04/30/2014 04/05/2024 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph not final part334 04/30/2014 04/05/2024 Labeler - P & L Development, LLC (800014821)