Label: PREFERRED STOOL SOFTENER LAXATIVE- docusate sodium capsule, liquid filled
- NDC Code(s): 10956-781-00
- Packager: Reese Pharmaceutical Co
- 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 May 11, 2023
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- Download DRUG LABEL INFO: PDF XML
- Official Label (Printer Friendly)
- SPL UNCLASSIFIED SECTION
- 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 movements that lasts over 2 weeks
- Directions
- Other information
- Inactive Ingredients
- PRINCIPAL DISPLAY PANEL
-
INGREDIENTS AND APPEARANCE
PREFERRED STOOL SOFTENER LAXATIVE
docusate sodium capsule, liquid filledProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:10956-781 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) SORBITOL (UNII: 506T60A25R) WATER (UNII: 059QF0KO0R) Product Characteristics Color red, white (Two-Tone) Score no score Shape CAPSULE (OVAL) Size 20mm Flavor Imprint Code SCU1 Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:10956-781-00 140 in 1 BOTTLE; Type 0: Not a Combination Product 05/11/2023 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph not final part334 05/11/2023 Labeler - Reese Pharmaceutical Co (004172052) Registrant - Reese Pharmaceutical Co (004172052)