Label: STOOL SOFTENER- docusate calcium capsule, liquid filled
- NDC Code(s): 59726-257-01
- Packager: P & L Development, LLC
- 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.
Drug Label Information
Updated October 26, 2021
If you are a consumer or patient please visit this version.
- Download DRUG LABEL INFO: PDF XML
- Official Label (Printer Friendly)
- Active ingredient (in each softgel)
- Purpose
- Uses
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Warnings
Ask a doctor before use if you have
- stomach pain
- nausea
- vomiting
- noticed a sudden change in bowel habits that lasts over 2 weeks
- Directions
- Other information
- Inactive ingredients
- Questions or comments?
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Principal Display Panel
Compare to the active ingredient in Surfak®†
Stool Softener
Docusate calcium 240 mg
Gentle Relief of Constipation
Take once a day
Softgels
†This product is not manufactured or distributed by Chattem, Inc., distributor of Surfak®.
Distributed by:
PL Developments
200 Hicks Street
Westbury, NY 11590
TAMPER EVIDENT: DO NOT USE IF IMPRINTED SAFETY SEAL UNDER CAP IS BROKEN OR MISSING.
- Product Label
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INGREDIENTS AND APPEARANCE
STOOL SOFTENER
docusate calcium capsule, liquid filledProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:59726-257 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 BLUE NO. 1 (UNII: H3R47K3TBD) FD&C RED NO. 40 (UNII: WZB9127XOA) FD&C YELLOW NO. 6 (UNII: H77VEI93A8) GELATIN (UNII: 2G86QN327L) GLYCERIN (UNII: PDC6A3C0OX) WATER (UNII: 059QF0KO0R) SORBITOL (UNII: 506T60A25R) SORBITAN (UNII: 6O92ICV9RU) Product Characteristics Color red Score no score Shape CAPSULE Size 18mm Flavor Imprint Code P58;SCU Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:59726-257-01 100 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product 04/30/2014 04/26/2024 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph not final part334 04/30/2014 04/26/2024 Labeler - P & L Development, LLC (800014821)