Label: STOOL SOFTENER- docusate calcium capsule, liquid filled
- NDC Code(s): 49348-122-10
- Packager: Strategic Sourcing Services 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.
Updated October 18, 2019
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- 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
Compare to Surfak® Active Ingredient**
For gentle relief of constipation
SOFTGELS 240 mg EACH
Another quality product Distributed by McKesson
One Post Street, San Francisco, CA 94104
Please visit us at www.sunmarkbrand.com
**This product is not manufactured or distributed by Chattem, Inc., distributor of Surfak®.
TAMPER EVIDENT:DO NOT USE IF IMPRINTED SAFETY SEAL UNDER CAP IS BROKEN OR MISSING.
KEEP OUTER CARTON FOR COMPLETE WARNINGS AND PRODUCT INFORMATION.
- Product Label
INGREDIENTS AND APPEARANCE
docusate calcium capsule, liquid filled
Product Information Product Type HUMAN OTC DRUG Item Code (Source) 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 (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:49348-122-10 1 in 1 BOX 05/30/2014 12/30/2021 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 05/30/2014 12/30/2021 Labeler - Strategic Sourcing Services LLC (116956644)