Label: DOCUSATE SODIUM- docusate sodium 100mg capsule
- NDC Code(s): 16103-399-08, 16103-399-11
- Packager: Pharbest Pharmaceuticals, 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.
Updated March 1, 2016
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- Active ingredient (in each softgel)
Docusate Sodium 100 mgClose
- 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 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
Keep out of reach of children.
In case of overdose, get medical help or contact a Poison Control Center right away. (1-800-222-1222)
- 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 softgels daily children 2 to under 12 years of age take 1 softgel daily children under 2 years ask a doctor
- Other information
- Tamper Evident: Do not use if safety seal under cap is broken or missing
- each softgel contains: sodium 6 mg
- VERY LOW SODIUM
- store at 25oC (77oF); excursions permitted between 15o-30oC (59o-86oF).
keep tightly closed.Close
- Inactive ingredients
D&C Red #33, edible ink, FD&C Red #40, FD&C Yellow #6, gelatin, glycerin, polyethylene glycol, purified water, sorbitol special, titanium dioxideClose
Adverse drug event call: (866) 562-2756 Mon-Fri 8 AM to 4 PMClose
- PRINCIPAL DISPLAY PANEL
*Compare to the active ingredient of Colace®
100 mg each
- INGREDIENTS AND APPEARANCE
docusate sodium 100mg capsule
Product Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:16103-399 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) WATER (UNII: 059QF0KO0R) SORBITOL (UNII: 506T60A25R) TITANIUM DIOXIDE (UNII: 15FIX9V2JP) Product Characteristics Color red (Two-toned- white and clear red) Score no score Shape OVAL Size 12mm Flavor Imprint Code SCU2 Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:16103-399-08 100 in 1 BOTTLE; Type 0: Not a Combination Product 03/01/2016 2 NDC:16103-399-11 1000 in 1 BOTTLE; Type 0: Not a Combination Product 03/01/2016 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph not final part334 03/01/2016 Labeler - Pharbest Pharmaceuticals, Inc. (557054835) Registrant - Pharbest Pharmaceuticals, Inc (557054835) Establishment Name Address ID/FEI Business Operations Pharbest Pharmaceuticals, Inc 557054835 repack(16103-399) , relabel(16103-399) Establishment Name Address ID/FEI Business Operations SWISSCAPS Romania srl 565466997 manufacture(16103-399)