Label: DOK EXTRA STRENGTH STOOL SOFTENER- docusate sodium capsule, liquid filled
Contains inactivated NDC Code(s)
NDC Code(s): 0440-1466-30
- Packager: Liberty Pharmaceuticals, Inc.
- This is a repackaged label.
- Source NDC Code(s): 0904-7891
- 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 September 13, 2013
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- Active ingredient (in each softgel)
Warnings - Do not use
- if you are taking mineral oil, unless directed by a doctor
- when abdominal pain, nausea, or vomiting are present
- for more 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
- Other information
- Inactive Ingredients
- Questions or comments?
- Product Labeling
- PRINCIPAL DISPLAY PANEL
INGREDIENTS AND APPEARANCE
DOK EXTRA STRENGTH STOOL SOFTENER
docusate sodium capsule, liquid filled
Product Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:0440-1466(NDC:0904-7891) Route of Administration ORAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength DOCUSATE SODIUM (UNII: F05Q2T2JA0) (DOCUSATE - UNII:M7P27195AG) DOCUSATE SODIUM 250 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) WATER (UNII: 059QF0KO0R) SORBITOL (UNII: 506T60A25R) Product Characteristics Color ORANGE (orange) Score no score Shape CAPSULE Size 20mm Flavor Imprint Code P20 Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:0440-1466-30 30 in 1 BOTTLE, PLASTIC Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC MONOGRAPH NOT FINAL part334 08/27/2002 Labeler - Liberty Pharmaceuticals, Inc. (012568840)