Label: DOCUSATE SODIUM - docusate sodium capsule
- NDC Code(s): 58602-767-64
- Packager: Aurohealth LLC
- 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.
Updated February 2, 2018
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- Active ingredient
(in each Capsule)Close
Docusate sodium 100 mg
- relieves occasional constipation (irregularity)
- generally produces bowel movement in 12 to 72 hours
Do not use
- if you are presently taking mineral oil, unless told to do so by a doctor
- Ask a doctor before use if you have
- stomach pain
- noticed a sudden change in bowel habits that lasts over 2 weeks
- Stop use and ask a doctor if
- you have rectal bleeding or fail to have a bowel movement after use of a laxative. These could be signs of a serious condition.
- you need to use a stool softener laxative for more than 1 week
- If pregnant or breast-feeding,
ask a health professional before use.Close
- Keep out of reach of children.
In case of overdose, get medical help or contact a Poison Control Center (1-800-222-1222) right away.Close
Take only by mouth. Doses may be taken as a single daily dose or in divided doses.
adults and children 12 years and over
take 1-3 capsules daily
children 2 to under 12 years of age
take 1 capsule daily
children under 2 years
ask a doctor
- Other information
- each capsule contains: sodium 5 mg Very Low Sodium
- store at 25°C (77°F); excursions permitted between 15-30ºC (59-86ºF). Keep tightly closed.
- Inactive ingredients
D&C Red No.33, gelatin, glycerin, Neelicert FD&C Red No.40, Neelicert FD&C Yellow No.6, noncrystallizing sorbitol solution, polyethylene glycol, propylene glycol, purified water, shellac glaze, titanium dioxide.Close
- Questions or Comments?
(Monday - Friday 8:30 AM to 5:00 PM EST)
*This product is not manufactured or distributed by Purdue Products L.P., owner of the registered trademark Colace®.
2572 Brunswick Pike
Lawrenceville, NJ 08648
- PACKAGE LABEL-PRINCIPAL DISPLAY PANEL - 100 mg (600 Capsules Container Label)
Compare to Colace®
Docusate sodium 100 mg
- Gentle, Dependable
- INGREDIENTS AND APPEARANCE
docusate sodium capsule
Product Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:58602-767 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) GELATIN TYPE B BOVINE (160 BLOOM) (UNII: 1T8387508X) GLYCERIN (UNII: PDC6A3C0OX) FD&C RED NO. 40 (UNII: WZB9127XOA) FD&C YELLOW NO. 6 (UNII: H77VEI93A8) SORBITOL (UNII: 506T60A25R) POLYETHYLENE GLYCOL 400 (UNII: B697894SGQ) PROPYLENE GLYCOL (UNII: 6DC9Q167V3) WATER (UNII: 059QF0KO0R) SHELLAC (UNII: 46N107B71O) TITANIUM DIOXIDE (UNII: 15FIX9V2JP) Product Characteristics Color RED Score no score Shape OVAL Size 13mm Flavor Imprint Code Q04 Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:58602-767-64 600 in 1 BOTTLE; Type 0: Not a Combination Product 02/08/2018 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC MONOGRAPH NOT FINAL part334 02/08/2018 Labeler - Aurohealth LLC (078728447) Establishment Name Address ID/FEI Business Operations Aurohealth LLC 078728447 MANUFACTURE(58602-767)