Label: DOCUSATE SODIUM - docusate sodium capsule, liquid filled
- NDC Code(s): 59105-007-50
- Packager: J.P. BUSINESS ENTERPRISE
- 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 November 17, 2014
If you are a healthcare professional or from the pharmaceutical industry please visit this version.
- SPL UNCLASSIFIED SECTION
- Active ingredient (in each softgel)
Docusate sodium 100 mgClose
- for prevention of dry, hard stools
- for relief of occasional constipation
This product generally produces a bowel movement within 12 to 72 hours.Close
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.
Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center right away.
- take with a glass of water
adults and children 12 years of age and over take 1 to 3 softgels daily. This dose may be taken as a single daily dose or in divided doses. children 2 to under 12 years of age take 1 softgel daily children under 2 years of age consult a physician
- Other information
- each softgel contains: sodium 6 mg
- store at controlled room temperature 15°-30°C (59°-86°F)
- do not use if imprinted safety seal under cap is broken or missing
- Inactive ingredients
FD&C Red # 40, FD&C Yellow #6, gelatin, glycerine, polyethylene glycol 400, propylene glycol, purified water, sorbitol solution, titanium dioxide (for printing)Close
- Questions or comments?
Call toll free: 1-888-333-9792Close
- SPL UNCLASSIFIED SECTION
Distributed By: J.P Business EnterpriseClose
Lake Grove, NY 11755
- PRINCIPAL DISPLAY PANEL - 50 Softgel Bottle Carton
Compare to the active ingredient in
Dulcolax® Stool Softener
DOCUSATE SODIUM 100 MG
- GENTLE RELIEF
- STIMULANT FREE
- INGREDIENTS AND APPEARANCE
docusate sodium capsule, liquid filled
Product Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:59105-007 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 POLYETHYLENE GLYCOL 400 (UNII: B697894SGQ) PROPYLENE GLYCOL (UNII: 6DC9Q167V3) GELATIN (UNII: 2G86QN327L) GLYCERIN (UNII: PDC6A3C0OX) SORBITOL (UNII: 506T60A25R) FD&C RED NO. 40 (UNII: WZB9127XOA) TITANIUM DIOXIDE (UNII: 15FIX9V2JP) WATER (UNII: 059QF0KO0R) Product Characteristics Color RED Score no score Shape OVAL Size 10mm Flavor Imprint Code 125 Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:59105-007-50 1 in 1 CARTON 1 50 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 12/01/2014 Labeler - J.P. BUSINESS ENTERPRISE (078775890) Establishment Name Address ID/FEI Business Operations MEDGEL PVT LTD 677385498 MANUFACTURE(59105-007)