FDA Label for Stool Softener
View Indications, Usage & Precautions
- ACTIVE INGREDIENT (IN EACH SOFTGEL)
- PURPOSE
- USES
- DO NOT USE
- ASK A DOCTOR BEFORE USE IF YOU HAVE
- STOP USE AND ASK A DOCTOR IF
- IF PREGNANT OR BREAST-FEEDING
- KEEP OUT OF REACH OF CHILDREN.
- DIRECTIONS
- OTHER INFORMATION
- INACTIVE INGREDIENTS
- QUESTIONS OR COMMENTS?
- HOW SUPPLIED
- PACKAGE LABEL.PRINCIPAL DISPLAY PANEL
Stool Softener Product Label
The following document was submitted to the FDA by the labeler of this product Bryant Ranch Prepack. 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
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
- each softgel contains: sodium 15 mg
- store between 20-25°C(68-77°F); excursions permitted between 15-30°C (59-86°F)
Inactive Ingredients
edible white ink, FD&C red #40, FD&C yellow #6, gelatin, glycerin, mannitol, polyethylene glycol, propylene glycol, purified water, sorbitan sorbitol
Questions Or Comments?
Call 1-800-616-2471
How Supplied
NDC: 71335-9738-1: 30 Capsules in a BOTTLE, PLASTIC
NDC: 71335-9738-2: 60 Capsules in a BOTTLE, PLASTIC
NDC: 71335-9738-3: 100 Capsules in a BOTTLE, PLASTIC
NDC: 71335-9738-4: 7 Capsules in a BOTTLE, PLASTIC
NDC: 71335-9738-5: 90 Capsules in a BOTTLE, PLASTIC
Package Label.Principal Display Panel
Docusate Sodium 250 mg Capsule
* Please review the disclaimer below.