Label: DOCUSATE SODIUM 100MG TWO-TONE- docusate sodium capsule, liquid filled
- NDC Code(s): 53943-250-10, 53943-250-25
- Packager: Discount Drug Mart, 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 December 28, 2022
If you are a consumer or patient please visit this version.
- 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
DOCUSATE SODIUM 100MG TWO-TONE
docusate sodium capsule, liquid filledProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:53943-250 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 ANHYDROUS CITRIC ACID (UNII: XF417D3PSL) D&C RED NO. 33 (UNII: 9DBA0SBB0L) 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) SORBITOL (UNII: 506T60A25R) WATER (UNII: 059QF0KO0R) Product Characteristics Color red, white (Two-Tone) Score no score Shape CAPSULE (OVAL) Size 10mm Flavor Imprint Code SCU2 Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:53943-250-25 1 in 1 CARTON 12/23/2019 1 250 in 1 BOTTLE; Type 0: Not a Combination Product 2 NDC:53943-250-10 1 in 1 CARTON 12/23/2019 2 100 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 12/23/2019 Labeler - Discount Drug Mart, Inc (047741335) Registrant - Reese Pharmaceutical (004172052) Establishment Name Address ID/FEI Business Operations Swiss Caps Romania 565466997 manufacture(53943-250)