Label: STOOL SOFTENER- docusate calcium capsule, liquid filled
Contains inactivated NDC Code(s)
NDC Code(s): 76413-324-30
- Packager: Central Texas Community Health Centers
- This is a repackaged label.
- Source NDC Code(s): 49348-122
- 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 October 31, 2016
If you are a consumer or patient please visit this version.
- Active ingredient (in each softgel)
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 a bowel movement after use of a laxative. These could be signs of a serious condition.
- you need to use a laxative for more than 1 week
- Other information
- Inactive Ingredients
- Questions or comments?
PRINCIPAL DISPLAY PANEL - 240 MG Capsule Bottle Label
CommUnityCare Federally Qualified Health Centers
TAKE 1 CAPSULE BY MOUTH DAILY AS DIRECTED.
DOCUSATE CA.240MG CAPS#30NDC 76413-324-30
Federal law prohibits the transfer of this drug to any other person than the patient for whom prescribed.
INGREDIENTS AND APPEARANCE
docusate calcium capsule, liquid filled
Product Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:76413-324(NDC:49348-122) 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, UNSPECIFIED (UNII: 2G86QN327L) GLYCERIN (UNII: PDC6A3C0OX) WATER (UNII: 059QF0KO0R) SORBITOL (UNII: 506T60A25R) FD&C BLUE NO. 1 (UNII: H3R47K3TBD) FD&C YELLOW NO. 6 (UNII: H77VEI93A8) Product Characteristics Color RED Score no score Shape CAPSULE Size 18mm Flavor Imprint Code P20;SCU Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:76413-324-30 30 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product 05/30/2014 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC MONOGRAPH NOT FINAL part334 05/30/2014 Labeler - Central Texas Community Health Centers (079674019) Establishment Name Address ID/FEI Business Operations Central Texas Community Health Centers 079674019 REPACK(76413-324) , RELABEL(76413-324)