FDA Label for Vegetable Laxative And Stool Softner
View Indications, Usage & Precautions
Vegetable Laxative And Stool Softner Product Label
The following document was submitted to the FDA by the labeler of this product Topco Associates Llc. 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.
Other
Drug Facts
Otc - Purpose
| Active ingredients (in each tablet) | Purposes |
|---|---|
| Docusate sodium 50 mg | Stool softener |
| Sennosides 8.6 mg | Laxative |
Uses
- relieves occasional constipation (irregularity)
- generally, produces bowel movement in 6 to 12 hours
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 habits 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 indicate a serious condition.
Otc - Pregnancy Or Breast Feeding
If pregnant or breast-feeding, ask a health professional before use.
Otc - Keep Out Of Reach Of Children
Keep out of reach of children. In case of overdose, get medical help 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 and over | 2 tablets once a day | 4 tablets twice a day |
| children 6 to under 12 years | 1 tablet once a day | 2 tablets twice a day |
| children 2 to under 6 years | ½ tablet once a day | 1 tablet twice a day |
| children under 2 years | ask a doctor | ask a doctor |
Other Information
- each tablet contains: calcium 20 mg, sodium 3 mg (low sodium)
- store between 20-25°C (68-77°F)
Inactive Ingredients
colloidal silicon dioxide, crosscarmellose sodium, dibasic calcium phosphate, FD&C yellow #6 aluminum lake, hypromellose, magnesium stearate, microcrystalline cellulose, polyethylene glycol, talc, titanium dioxide
Questions?
Call 1-888-423-0139
Principal Display Panel - 60 Tablet Bottle Carton
NDC 36800-163-60
*Compare to the active ingredients
in Senakot-S®
Senna-S
DOCUSATE SODIUM 50 mg
STOOL SOFTENER
SENNOSIDES 8.6 mg
LAXATIVE
Vegetable laxative ingredient
plus stool softener
60 TABLETS
actual size
* Please review the disclaimer below.