Label: STOOL SOFTENER- docusate calcium capsule, liquid filled
- NDC Code(s): 0536-1065-01, 0536-1065-05, 0536-1065-10
- Packager: Rugby Laboratories, Inc.
- Category: HUMAN OTC DRUG LABEL
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 June 18, 2020
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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 the active ingredient in Surfax®**
Docusate calcium 240mg
Gentle Relief of Constipation
Take Once a Day
**This product is not manufactured or distributed by Chattem, Inc., distributor of Surfak®
This is a bulk package. Dispense contents with a child-resistant closure in a tight, light-resistant container as defined in the USP.
Distributed by: Rugby Laboratories
17177 N Laurel Park Drive, Suite 233
Livonia, MI 48152
TAMPER EVIDENT: DO NOT USE IF PRINTED SAFETY SEAL UNDER CAP IS BROKEN OR MISSING
- Product Label
INGREDIENTS AND APPEARANCE
docusate calcium capsule, liquid filled
Product Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:0536-1065 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) 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:0536-1065-01 100 in 1 BOTTLE; Type 0: Not a Combination Product 01/31/2015 2 NDC:0536-1065-05 500 in 1 BOTTLE; Type 0: Not a Combination Product 01/31/2015 3 NDC:0536-1065-10 1000 in 1 BOTTLE; Type 0: Not a Combination Product 01/31/2015 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC MONOGRAPH NOT FINAL part334 01/31/2015 Labeler - Rugby Laboratories, Inc. (079246066)