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?
- PRINCIPAL DISPLAY PANEL - 240 MG CAPSULE BOTTLE LABEL
Stool Softener Product Label
The following document was submitted to the FDA by the labeler of this product Central Texas Community Health Centers. 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 calcium 240 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 currently 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 lasts 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 at 20°-25°C (68°-77°F); excursions permitted between 15°-30°C (59°-86°F)
Inactive Ingredients
corn oil, D&C red #33*, edible white ink, FD&C blue #1*, FD&C red #40, FD&C yellow #6*, gelatin, glycerin, purified water, sorbitol special
*contains one or more of these ingredients
Questions Or Comments?
Call 1-877-753-3935 Monday-Friday 9AM-5PM EST
Principal Display Panel - 240 Mg Capsule Bottle Label
CommUnityCare Federally Qualified Health Centers
DOCUSATE
CALCIUM
240 MG
CAPS
Date:
Name:
Dr.
TAKE 1 CAPSULE BY MOUTH DAILY AS DIRECTED.
123456
1/1/01
DOCUSATE CA.240MG CAPS#30NDC 76413-324-30
Batch: 123456
Lot: 123456
Exp: 1/1/01
SUNMARK
Federal law prohibits the transfer of this drug to any other person than the patient for whom prescribed.
* Please review the disclaimer below.