FDA Label for Stimulant Laxative Plus Stool Softener
View Indications, Usage & Precautions
Stimulant Laxative Plus Stool Softener Product Label
The following document was submitted to the FDA by the labeler of this product Rugby Laboratories. 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 Ingredients (In Each Tablet)
Docusate Sodium 50 mg
Sennosides 8.6 mg
Purpose
Stool softener
Stimulant laxative
Uses
- relieves occasional constipation (irregularity)
- generally produces a bowel movement in 6 to 12 hours
Do Not Use
- laxative products for longer than 1 week unless told to do so by a doctor
- if you are presently taking mineral oil, unless told to do so 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 2 weeks
Stop Use And Ask A Doctor If
you have rectal bleeding or fail to have a bowel movement after the use of a laxative.
These could be sings of a serious condition.
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 (1-800-222-1222).
Directions
- take only by mouth. Doses may be taken as a single daily dose, preferably in the evening, or in divided doses
adults and children 12 years and over | take 2-4 tablets daily | |
children 6 to under 12 years of age | take 1-2 tablets daily | |
children 2 to under 6 years of age | take upto 1 tablet daily | |
children under 2 | ask a doctor |
Other Information
- each tablet contains: calcium 10 mg, sodium 5 mg, Very Low Sodium
- store at 20-25°C (68-77°F); excursions permitted between 15-30oC (59-86oF)
Inactive Ingredients
croscarmellose sodium, dicalcium phosphate, FD&C Red #40, magnesium stearate, microcrystalline cellulose, polyethylene glycol, polyvinyl alcohol, sodium benzoate, talc, titanium dioxide
Questions Or Comments?
1-800-645-2158
Package Label.Principal Display Panel
RUGBY®
NDC 0536-1248-10
Compare to the
active ingredients
in Colace® 2-IN-1*
Stimulant
Laxative
Plus Stool Softener
Docusate Sodium, 50 mg
Sennosides, 8.6 mg
50 mg/ 8.6 mg
1000 TABLETS
* Please review the disclaimer below.