Label: DOCUSATE CALCIUM capsule
Contains inactivated NDC Code(s)
NDC Code(s): 0615-0378-39
- Packager: NCS HealthCare of KY, Inc dba Vangard Labs
- This is a repackaged label.
- Source NDC Code(s): 0904-5779
- 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 28, 2013
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- Active ingredient (in each softgel)
Do not use
-if you are currently taking mineral oil, unless directed by a doctor
-when abdominal pain, nausea, or vomiting are present
-for longer 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
- Principal Display Panel
INGREDIENTS AND APPEARANCE
docusate calcium capsule
Product Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:0615-0378(NDC:0904-5779) Route of Administration ORAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength DOCUSATE CALCIUM (UNII: 6K7YS503HC) (DOCUSATE - UNII:M7P27195AG) DOCUSATE CALCIUM 240 mg Inactive Ingredients Ingredient Name Strength CORN OIL (UNII: 8470G57WFM) D&C RED NO. 33 (UNII: 9DBA0SBB0L) FD&C RED NO. 40 (UNII: WZB9127XOA) GELATIN (UNII: 2G86QN327L) GLYCERIN (UNII: PDC6A3C0OX) WATER (UNII: 059QF0KO0R) SORBITOL (UNII: 506T60A25R) Product Characteristics Color RED Score no score Shape CAPSULE Size 21mm Flavor Imprint Code P58 Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:0615-0378-39 30 in 1 BLISTER PACK Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC MONOGRAPH NOT FINAL part334 12/01/2011 Labeler - NCS HealthCare of KY, Inc dba Vangard Labs (050052943) Establishment Name Address ID/FEI Business Operations NCS HealthCare of KY, Inc dba Vangard Labs 050052943 RELABEL(0615-0378) , REPACK(0615-0378)