Label: STOOL SOFTENER LAXATIVE- docusate sodium capsule, liquid filled
- NDC Code(s): 72476-853-10, 72476-853-25
- Packager: Care One (Retail Business Services, LLC.)
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
Drug Label Information
Updated March 5, 2024
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- Official Label (Printer Friendly)
- Active Ingredient (in each softgel)
- Purpose
- Uses
-
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
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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 Avrio Health 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
- Product Label
-
INGREDIENTS AND APPEARANCE
STOOL SOFTENER LAXATIVE
docusate sodium capsule, liquid filledProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:72476-853 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 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) D&C RED NO. 33 (UNII: 9DBA0SBB0L) FERROSOFERRIC OXIDE (UNII: XM0M87F357) Product Characteristics Color red, white Score no score Shape OVAL Size 12mm Flavor Imprint Code P10 Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:72476-853-25 250 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product 03/26/2021 2 NDC:72476-853-10 100 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product 03/26/2021 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC Monograph Drug M007 03/26/2021 Labeler - Care One (Retail Business Services, LLC.) (967989935)