Label: STOOL SOFTENER LAXATIVE- docusate sodium capsule, liquid filled
- NDC Code(s): 41520-779-10, 41520-779-25
- Packager: Care One (American Sales Company)
- 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 21, 2022
If you are a consumer or patient please visit this version.
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- 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
- a sudden change in bowel habits that lasts over 14 days
- Directions
- Other information
- Inactive ingredients
- Questions or comments?
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Principal Display Panel
Compare to the active ingredient in Colace® Regular Strength Stool Softener†
STOOL SOFTENER LAXATIVE
Docusate Sodium 100 mg
SOFTGELS
†This product is not manufactured or distributed by Purdue Products L.P., distributor of Colace® Regular Strength Stool Softener.
TAMPER EVIDENT: DO NOT USE IF PRINTED SAFETY SEAL UNDER CAP IS BROKEN OR MISSING.
DISTRIBUTED BY FOODHOLD U.S.A., LLC
LANDOVER, MD 20785 •-877-846-9949
- Product Label
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INGREDIENTS AND APPEARANCE
STOOL SOFTENER LAXATIVE
docusate sodium capsule, liquid filledProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:41520-779 Route of Administration ORAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength DOCUSATE SODIUM (UNII: F05Q2T2JA0) (DOCUSATE - UNII:M7P27195AG) DOCUSATE SODIUM 100 mg Inactive Ingredients Ingredient Name Strength 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) POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A) PROPYLENE GLYCOL (UNII: 6DC9Q167V3) WATER (UNII: 059QF0KO0R) SORBITAN (UNII: 6O92ICV9RU) SORBITOL (UNII: 506T60A25R) TITANIUM DIOXIDE (UNII: 15FIX9V2JP) Product Characteristics Color red, white Score no score Shape OVAL Size 12mm Flavor Imprint Code P10;SCU2;D1 Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:41520-779-10 1 in 1 BOX 09/30/2018 12/27/2024 1 100 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product 2 NDC:41520-779-25 250 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product 09/30/2018 12/27/2024 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph not final part334 09/30/2018 12/27/2024 Labeler - Care One (American Sales Company) (809183973)