Label: DOCUSATE SODIUM capsule, liquid filled
- NDC Code(s): 63187-476-00, 63187-476-30, 63187-476-60, 63187-476-90
- Packager: Proficient Rx LP
- This is a repackaged label.
- Source NDC Code(s): 66424-030
- Category: HUMAN OTC DRUG LABEL
Drug Label Information
Updated February 1, 2024
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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 or vomiting
- •
- have noticed a sudden change in bowel habits that lasts over 2 weeks
- Directions
- Other information
- Inactive ingredients: D&C red #33, Edible ink, FD&C red #40, FD&C yellow #6, gelatin, glycerin, polyethylene glycol, propylene glycol, sorbitol special
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INGREDIENTS AND APPEARANCE
DOCUSATE SODIUM
docusate sodium capsule, liquid filledProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:63187-476(NDC:66424-030) 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 D&C RED NO. 33 (UNII: 9DBA0SBB0L) FD&C RED NO. 40 (UNII: WZB9127XOA) FD&C YELLOW NO. 6 (UNII: H77VEI93A8) GELATIN, UNSPECIFIED (UNII: 2G86QN327L) GLYCERIN (UNII: PDC6A3C0OX) POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A) PROPYLENE GLYCOL (UNII: 6DC9Q167V3) SORBITOL (UNII: 506T60A25R) Product Characteristics Color red (Two toned- white and clear red) Score no score Shape OVAL Size 5mm Flavor Imprint Code 51A Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:63187-476-30 30 in 1 BOTTLE; Type 0: Not a Combination Product 01/01/2019 2 NDC:63187-476-60 60 in 1 BOTTLE; Type 0: Not a Combination Product 01/01/2019 3 NDC:63187-476-90 90 in 1 BOTTLE; Type 0: Not a Combination Product 01/01/2019 4 NDC:63187-476-00 100 in 1 BOTTLE; Type 0: Not a Combination Product 01/01/2019 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC Monograph Drug M007 09/15/2010 Labeler - Proficient Rx LP (079196022) Establishment Name Address ID/FEI Business Operations Proficient Rx LP 079196022 REPACK(63187-476) , RELABEL(63187-476)