FDA Label for Docusate Sodium And Sennosides
View Indications, Usage & Precautions
Docusate Sodium And Sennosides Product Label
The following document was submitted to the FDA by the labeler of this product Softgel Healthcare Pvt Ltd. The document includes published materials associated whith this product with the essential scientific information about this product as well as other prescribing information. Product labels may durg indications and usage, generic names, contraindications, active ingredients, strength dosage, routes of administration, appearance, warnings, inactive ingredients, etc.
Active Ingredient (In Each Softgel)
Docusate Sodium 50 mg
Sennosides 8.6 mg
Purpose
Stool softener
Laxative
Uses
- relieves occasional constipation (irregularity)
- generally causes bowel movement in 6-12 hours
Warnings Do Not Use
- if you are now taking mineral oil, unless directed by a doctor
- laxative products for longer than 1 week, unless directed by a doctor
Ask A Doctor Before Use If You Have
- stomach pain
- nausea
- vomiting
- noticed a sudden change in bowel movements that continues over a period of 2 weeks
Stop Use And Ask A Doctor If You Have
- rectal bleeding or fail to have a bowel movement after use of a laxative. These may be signs of a serious condition.
If Pregnant Or Breast-Feeding,
ask a health professional before use.
Keep Out Of Reach Of Children.
In case of accidental overdose, seek professional assistance or contact a Poison Control Center right away.
Directions
- take preferably at bedtime or as directed by a doctor.
Age Starting Dosage Maximum Dosage adults and children 12 years of age and older 2 softgels once a day 4 softgels twice a day children 6 to 12 years 1 softgel once a day 2 softgels twice a day children under 6 years of age ask a doctor ask a doctor
Other Information
- each softgel contains: Sodium 3 mg
- store at 25°C (77°F); excursions permitted between 15°- 30°C (59°- 86°F)
Inactive Ingredients
Propylene glycol, Povidone, Colloidal Silicon Dioxide, Yellow wax, Polyethylene glycol 400, Gelatin, Glycerin, Sorbitol Sorbitan Solution, FD&C Yellow No.6, Titanium dioxide and Purified water.
* Please review the disclaimer below.
