Label: STOOL SOFTENER - docusate sodium capsule, liquid filled
- NDC Code(s): 50436-1223-1
- Packager: Unit Dose Services
- This is a repackaged label.
- Source NDC Code(s): 57896-401
- 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 30, 2013
If you are a consumer or patient please visit this version.
- Active ingredient (in each softgel)
Docusate Sodium 100 mgClose
Stool Softener LaxativeClose
- relieves occasional constipation (irregularity)
- generally produces bowel movement in 12 to 72 hours
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.
ask a health professional before use. If pregnant or breast-feeding,
In case of overdose, get medical help or contact a Poison Control Center right away. Keep out of reach of children.
• adults and children 12 years and older: take 1-2 softgel daily until first bowel movement; 1 softgel daily thereafter, or as directed by doctor
• children under 12: consult a doctor
• do not exceed recommended doseClose
- Other information
• sodium 5 mg. very low sodium each softgel contains:
• store at 15°C-25°C(59° F-77° F)
• keep tightly closed
• product from USA or Canada
• Do not use if imprinted seal under cap is missing or broken. Tamper Evident:Close
- Inactive ingredients
FD and C red 40, gelatin, glycerin, edible ink, PEG, propylene glycol, sorbitol special, water. May also contain D and C yellow 10, FD and C yellow 6 (sunset yellow), mannitol.Close
- STOOL SOFTENER (DOCUSATE SODIUM) CAPSULE, LIQUID FILLED
- INGREDIENTS AND APPEARANCE
docusate sodium capsule, liquid filled
Product Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:50436-1223(NDC:57896-401) 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) GELATIN (UNII: 2G86QN327L) GLYCERIN (UNII: PDC6A3C0OX) POLYETHYLENE GLYCOL 400 (UNII: B697894SGQ) PROPYLENE GLYCOL (UNII: 6DC9Q167V3) SORBITOL (UNII: 506T60A25R) WATER (UNII: 059QF0KO0R) D&C YELLOW NO. 10 (UNII: 35SW5USQ3G) FD&C YELLOW NO. 6 (UNII: H77VEI93A8) MANNITOL (UNII: 3OWL53L36A) Product Characteristics Color red (reddish) Score no score Shape OVAL Size 12mm Flavor Imprint Code SCU1 Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:50436-1223-1 30 in 1 BOTTLE Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph not final part334 01/01/2000 Labeler - Unit Dose Services (831995316) Registrant - Unit Dose Services (831995316) Establishment Name Address ID/FEI Business Operations Unit Dose Services 831995316 REPACK(50436-1223)