Label: DOCUSATE SODIUM- stool softener capsule, liquid filled
- 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 December 25, 2017
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- Active ingredient (in each softgel)
Ask a doctor before use if you
- have stomach pain, nausea, or vomiting
- have a sudden change in bowel habits that persists over a period of 2 weeks
- are presently taking mineral oil
Stop use and ask a doctor if
- you need to use a laxative longer than 1 week
- you have rectal bleeding or fail to have a bowel movement.
These could be signs of a serious condition.
If pregnant or breast-feeding, ask a health professional before
- Other information
- Inactive ingredients
- package Label
INGREDIENTS AND APPEARANCE
stool softener capsule, liquid filled
Product Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:57896-425 Route of Administration ORAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength DOCUSATE SODIUM (UNII: F05Q2T2JA0) (DOCUSATE - UNII:M7P27195AG) DOCUSATE SODIUM 250 mg Inactive Ingredients Ingredient Name Strength FD&C YELLOW NO. 6 (UNII: H77VEI93A8) GELATIN (UNII: 2G86QN327L) GLYCERIN (UNII: PDC6A3C0OX) SORBITOL (UNII: 506T60A25R) SORBITAN (UNII: 6O92ICV9RU) WATER (UNII: 059QF0KO0R) FD&C RED NO. 40 (UNII: WZB9127XOA) POLYETHYLENE GLYCOL 400 (UNII: B697894SGQ) PROPYLENE GLYCOL (UNII: 6DC9Q167V3) Product Characteristics Color red Score no score Shape OVAL (capsule) Size 23mm Flavor Imprint Code GC425 Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:57896-425-01 100 in 1 BOTTLE; Type 0: Not a Combination Product 06/01/2016 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph not final part334 05/01/2016 Labeler - Geri-Care Pharmaceutical Corp (611196254) Registrant - Geri-Care Pharmaceutical Corp (611196254)