FDA Label for Docusate Sodium
View Indications, Usage & Precautions
- ACTIVE INGREDIENT (IN EACH SOFTGEL)
- PURPOSE
- USES
- DO NOT USE
- ASK A DOCTOR BEFORE USE IF YOU HAVE
- ASK A DOCTOR OR PHARMACIST BEFORE USE IF YOU ARE
- WHEN USING THIS PRODUCT
- STOP USE AND ASK A DOCTOR IF
- IF PREGNANT OR BREAST-FEEDING,
- KEEP OUT OF REACH OF CHILDREN.
- DIRECTIONS
- OTHER INFORMATION
- INACTIVE INGREDIENTS
- QUESTIONS?
- PRINCIPAL DISPLAY PANEL
Docusate Sodium Product Label
The following document was submitted to the FDA by the labeler of this product Redpharm Drug, Inc.. 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 100 mg
Purpose
Stool softener laxative
Uses
- relieves occasional constipation (irregularity)
- generally produces bowel movement in 12 to 72 hours
Do Not Use
- 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 lasts over 2 weeks
Ask A Doctor Or Pharmacist Before Use If You Are
taking any other drug. Take this product two or more hours before or after other drugs. Laxatives may affect how other drugs work.
When Using This Product
do not exceed the maximum recommended daily dosage in a 24-hour period
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. (1-800-222-1222)
Directions
- Take only by mouth. Doses may be taken as a single daily dose or in divided doses.
adults and children 12 years and over | take 1 - 3 softgels daily |
children 2 to under 12 years of age | take 1 softgel daily |
children under 2 years | ask a doctor |
Other Information
- each softgel contains: sodium 6 mg
- very low sodium
- store at 20-25°C (68-77°F)
Inactive Ingredients
D&C red no. 33, edible ink, FD&C blue no. 1, FD&C red no. 40, FD&C yellow no. 6, gelatin, glycerin, polyethylene glycol, purified water, sorbitol sorbitan solution, titanium dioxide
Questions?
1-800-719-9260
Principal Display Panel
Compare to Colace ® active ingredient
Docusate Sodium
100 mg
Stool Softener Laxative
Gentle and Predictable
Relief of Constipation
100 Softgels
Stimulant Free
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