Label: STOOL SOFTENER GENTLE- docusate sodium capsule
- NDC Code(s): 50804-005-25
- Packager: Good Sense (Geiss, Destin & Dunn, Inc.)
- 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 April 19, 2013
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- Active ingredient (in each softgel)
Docusate Sodium 100 mgClose
- temporary relief of occasional constipation
- this product generally produces a bowel movement within 12 to 72 hours
Ask a doctor before use if
- you notice a sudden change in bowel habits that persists over a period of 2 weeks
- you are presently taking mineral oil
Stop use and ask a doctor if
- rectal bleeding or failure to have a bowel movement occur after use which may indicate a serious condition
- you need to use a laxative for more than 1 week
Keep out of reach of children.
In case of overdose, get medical help or contact a Poison Control Center immediately.
- take with a glass of water
adults and children 12 years of age and over take 1 to 3 softgels daily. This dose may be taken as a single daily dose or in divided doses. children 2 to under 12 years of age take 1 softgel daily children under 2 years of age ask a doctor
- Other information
- each softgel contains: sodium 6 mg
- store at controlled room temperature 15º-30ºC (59º-86ºF)
- Inactive ingredients
edible ink, FD&C Red #40, FD&C Yellow #6, gelatin, glycerin, polyethylene glycol, propylene glycol, purified water and sorbitol specialClose
- Questions or comments?
Call 1-877-753-3935 Monday-Friday 9AM-5PM ESTClose
- Principal Display Panel
Gentle Stool Softener
For Gentle, Softening Relief
Softgels (100 mg Each)
*Compare to active ingredient in Dulcolax® Stool Softener
*This product is not manufactured or distributed by Boehringer Ingelheim Consumer Healthcare, owner of the registered trademark of Dulcolax®.
Distributed by: Geiss, Destin & Dunn, Inc.
Peachtree City, GA 30269
Product of USA
DO NOT USE IF IMPRINTED SAFETY SEAL UNDER CAP IS BROKEN OR MISSING
KEEP OUTER CARTON FOR COMPLETE WARNINGS AND PRODUCT INFORMATIONClose
- Product Label
Good Sense Stool Softener Orange Softgel
- INGREDIENTS AND APPEARANCE
STOOL SOFTENER GENTLE
docusate sodium capsule
Product Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:50804-005 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 RED NO. 40 (UNII: WZB9127XOA) FD&C YELLOW NO. 6 (UNII: H77VEI93A8) GELATIN (UNII: 2G86QN327L) GLYCERIN (UNII: PDC6A3C0OX) POLYETHYLENE GLYCOLS (UNII: 3WJQ0SDW1A) PROPYLENE GLYCOL (UNII: 6DC9Q167V3) WATER (UNII: 059QF0KO0R) SORBITOL (UNII: 506T60A25R) SORBITAN (UNII: 6O92ICV9RU) Product Characteristics Color ORANGE Score no score Shape OVAL Size 13mm Flavor Imprint Code P51 Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:50804-005-25 1 in 1 BOX 1 25 in 1 BOTTLE, PLASTIC Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC MONOGRAPH NOT FINAL part334 08/24/2010 Labeler - Good Sense (Geiss, Destin & Dunn, Inc.) (076059836) Registrant - P and L Development of New York Corporation (800014821)