Label: DOCUSATE CALCIUM STOOL SOFTENER- docusate calcium capsule, liquid filled
- NDC Code(s): 24385-435-78
- Packager: AmerisourceBergen Drug Corporation (Good Neighbor Pharmacy) 24385
- 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 25, 2016
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- Active Ingredient (in each softgel)
Warnings- 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
- Questions or comments?
- Principal Display Panel
- Product Label
INGREDIENTS AND APPEARANCE
DOCUSATE CALCIUM STOOL SOFTENER
docusate calcium capsule, liquid filled
Product Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:24385-435 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:24385-435-78 1 in 1 CARTON 07/12/2010 12/30/2019 1 100 in 1 BOTTLE; Type 0: Not a Combination Product Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC MONOGRAPH NOT FINAL part334 07/12/2010 12/30/2019 Labeler - AmerisourceBergen Drug Corporation (Good Neighbor Pharmacy) 24385 (007914906)