FDA Label for Prolaxa
View Indications, Usage & Precautions
Prolaxa Product Label
The following document was submitted to the FDA by the labeler of this product Terrain Pharmaceuticals. 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 250 mg - Extra Strength
Purpose
Stool softener laxative
Uses
- for relief of occasional constipation
- this product generally produces a bowel movement within 12 to 72 hours
Do Not Use
if you are presently taking mineral oil, 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 last over 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 could be signs of a serious condition.
- you need to use a laxative for more than 1 week
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.
Directions
- adults and children 12 years of age and over: take 1 softgel daily or as directed by a doctor
- children under 12 years of age: ask a doctor
Other Information
- store between 20-25°C(68-77°F); excursions permitted between 15-30°C (59-86°F)
Inactive Ingredients
GELATIN, GLYCERIN, POLYETHYLENE GLYCOL, PROPYLENE GLYCOL, SORBITAN
Questions Or Comments?
Call toll free (877) 985-8377 or [email protected]
Prolaxa™
PROLAXA™
Stool Softener
DOCUSATE SODIUM, 250 mg
STOOL SOFTENER LAXATIVE - SOFTGELS
- MAXIMUM STRENGTH
- Easy to swallow
- Relieves constipation
- Gentle Relieve
- Dependable
- Stimulant Free
TAMPER EVIDENT: DO NOT USE IF PRINTED SAFETY SEAL UNDER CAP IS BROKEN OR MISSING.
Package Label; Display Panel
Prolaxa™ Drug Facts
* Please review the disclaimer below.
