Label: STOOL SOFTENER- docusate sodium capsule
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Contains inactivated NDC Code(s)
NDC Code(s): 68391-110-04 - Packager: BJWC (Berkley & Jensen / BJ's)
- 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.
Drug Label Information
Updated January 16, 2013
If you are a consumer or patient please visit this version.
- Download DRUG LABEL INFO: PDF XML
- Official Label (Printer Friendly)
- Active Ingredient (in each softgel)
- Uses
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Warnings - 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
- nausea
- vomiting
- noticed a sudden change in bowel habits that lasts over 2 weeks
- Directions
- Other information
- Inactive Ingredients
- Questions or Comments?
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Principal Display Panel
Compare to the active ingredient of COLACE®*
stool softener
Docusate sodium, 100 mg
Convenient & Predictable relief of constipation
DO NOT USE IF IMPRINTED SAFETY SEAL UNDER CAP IS BROKEN OR MISSING
*This product is not manufactured or distributed by Purdue Products L.P., owner of the registered trademark Colace®
- Product Label
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INGREDIENTS AND APPEARANCE
STOOL SOFTENER
docusate sodium capsuleProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:68391-110 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) GLYCERIN (UNII: PDC6A3C0OX) POLYETHYLENE GLYCOLS (UNII: 3WJQ0SDW1A) PROPYLENE GLYCOL (UNII: 6DC9Q167V3) SORBITOL (UNII: 506T60A25R) D&C RED NO. 33 (UNII: 9DBA0SBB0L) TITANIUM DIOXIDE (UNII: 15FIX9V2JP) FD&C BLUE NO. 1 (UNII: H3R47K3TBD) WATER (UNII: 059QF0KO0R) Product Characteristics Color RED, WHITE Score no score Shape OVAL Size 13mm Flavor Imprint Code P10;51A Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:68391-110-04 400 in 1 BOTTLE Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC MONOGRAPH NOT FINAL part334 06/10/2013 Labeler - BJWC (Berkley & Jensen / BJ's) (159082692) Registrant - P and L Development of New York Corporation (800014821)