Label: DOCUSATE SODIUM capsule, gelatin coated
- NDC Code(s): 68998-314-01
- Packager: Marc Glassman, Inc.
- Category: HUMAN OTC DRUG LABEL
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.
Updated December 28, 2016
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- Active ingredient
Do not use
■ if you are currently taking mineral oil, unless directed by a doctor
■ when abdominal pain, nausea, or vomiting are present
■ for longer than 1 week unless directed by a doctor
Ask a doctor before use if you
notice a sudden change in bowel habits that persists over a period of 2 weeks
Stop use and ask a doctor if you
■ have rectal bleeding
■ fail to have a bowel movement occur after use
- Other information
- Inactive ingredients
- Principal Display Panel
INGREDIENTS AND APPEARANCE
docusate sodium capsule, gelatin coated
Product Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:68998-314 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) POLYETHYLENE GLYCOL 400 (UNII: B697894SGQ) SORBITOL (UNII: 506T60A25R) Product Characteristics Color RED Score no score Shape OVAL Size 8mm Flavor Imprint Code SCU1 Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:68998-314-01 100 in 1 BOTTLE; Type 0: Not a Combination Product 12/23/2014 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC MONOGRAPH NOT FINAL part334 12/23/2014 Labeler - Marc Glassman, Inc. (094487477)