Label: DOCUSATE SODIUM - docusate sodium capsule
- NDC Code(s): 16103-384-08, 16103-384-11
- 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 July 6, 2010
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- Active ingredient (in each softgel)
Docusate sodium 100 mg
- prevents/relieves dry hard stool
- results usually occurs 1 to 3 days after the first dose
Do not use
- when abdominal pain, nausea, or vomiting are present
- for more than one week unless directed by a doctor
Ask a doctor before use if you
- are taking mineral oil
- have noticed a sudden change in bowel habits that last over 2 weeks
Stop use and ask a doctor if
- you have no bowel movement after 3 days
- you have rectal bleeding
Keep out of reach of children.
In case of overdose, get medical help or contact a Poison Control Center right away.
- do not exceed recommended dose
adults and children over 12 years
take 1-2 softgels daily until first bowel movement; 1 softgel daily thereafter
children 6 to 12 years
take 1 softgel daily
children under 6 years
consult a doctor
- Other information
- Tamper Evident: Do not use if safety seal under cap is broken or missing
- store at room temperature 15o to 30oC (59o to 86oF)
- protect from moisture
- Inactive ingredients: D&C yellow #10, FD&C red #40, gelatin, glycerin, ink white, polyethylene glycol, sorbitol, propylene glycol.
Adverse drug event call: (866) 562-2756Close
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*Compare to the active ingredient of Colace®
100 mg each
- INGREDIENTS AND APPEARANCE
docusate sodium capsule
Product Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:16103-384 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 Yellow No. 10 (UNII: 35SW5USQ3G) FD&C Red No. 40 (UNII: WZB9127XOA) Gelatin (UNII: 2G86QN327L) Glycerin (UNII: PDC6A3C0OX) Polyethylene Glycol (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:16103-384-08 100 in 1 BOTTLE 2 NDC:16103-384-11 1000 in 1 BOTTLE Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph not final part334 01/22/2007 Labeler - Pharbest Pharmaceuticals, Inc. (557054835) Establishment Name Address ID/FEI Business Operations Pharbest Pharmaceuticals, Inc 557054835 repack Establishment Name Address ID/FEI Business Operations Accucaps Industries Ltd. 248441727 manufacture