Label: STOOL SOFTENER DC LAXATIVE- docusate calcium capsule, liquid filled
Contains inactivated NDC Code(s)
NDC Code(s): 17856-3700-1
- Packager: ATLANTIC BIOLOGICALS CORP.
- This is a repackaged label.
- Source NDC Code(s): 0536-3755
- 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 April 24, 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.
Stop use and ask a doctor if
- you have rectal bleeding
- you fail to have a bowel movement after use
These could be signs of s serious condition.
- Other information
- Inactive ingredients
- Questions or comments?
Principal Display Panel
Compare to active ingredient in SURFAK®*
Safe, Effective, Non-Habit Forming
Stool Softener Laxative DC
Docusate Calcium USP, 240 mg
TAMPER EVIDENT: DO NOT USE IF IMPRINTED SAFETY SEAL UNDER CAP IS BROKEN OR MISSING
*Rugby Laboratories is not affiliated with the owner of the trademark Surfak®.
Distributed by: Atlantic Biologicals Corp
Miami, Fl 33179
INGREDIENTS AND APPEARANCE
STOOL SOFTENER DC LAXATIVE
docusate calcium capsule, liquid filled
Product Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:17856-3700(NDC:0536-3755) 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 (RED) Score no score Shape OVAL (OVAL) Size 8mm Flavor Imprint Code P58 Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:17856-3700-1 1 in 1 POUCH; Type 0: Not a Combination Product 09/02/2016 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC MONOGRAPH NOT FINAL part334 09/04/2013 Labeler - ATLANTIC BIOLOGICALS CORP. (047437707) Establishment Name Address ID/FEI Business Operations ATLANTIC BIOLOGICALS CORP. 047437707 repack(17856-3700)