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 Private Limited. 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
Otc - Ask Doctor
Ask a doctor if you have
- stomach pain
- nausea
- vomiting
- noticed a sudden change in bowel movements that continues over a period of 2 weeks
Otc - Stop Use
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.
Otc - Pregnancy Or Breast Feeding
If pregnant or breast-feeding, ask a health professional before use.
Keep Out Of Reach Of Children.
In case of overdose, get medical help or contact a Poison Control Center right away.
Dosage & Administration
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 Safety Information
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
colloidal silicon dioxide, FD&C yellow no.6, gelatin, glycerin, polyethylene glycol 400, povidone K 30, propylene glycol, purified water, sorbitol sorbitan solution, titanium dioxide, yellow wax.
Package Label.Principal Display Panel
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