FDA Label for Docusate Sodium
View Indications, Usage & Precautions
Docusate Sodium Product Label
The following document was submitted to the FDA by the labeler of this product National Vitamin Company. 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
Uses
• For the relief of occasional constipation.• Helps to prevent dry, hard stools.• This product generally produces a bowel movement within 12 to 72 hours.
Warnings Do Not Use:
• If you are currently taking mineral oil, unless directed by a doctor.• When abdominal pain, nausea, or vomiting are present.• For longer than one week unless directed by a doctor.
Ask A Doctor Before Use
if you notice a sudden change in bowel habits that persists over a period of two weeks.
Stop Use And Ask A Doctor
if you have rectal bleeding or you fail to have a bowel movement after use.
If You Are Pregnant Or Breast-Feeding,
ask a healthcare 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 over 12 years of age | Take orally 1 to 2 softgels preferably at bedtime for |
Children 6 to 12 years of age | Take orally 1 softgel preferably at bedtime for |
Children under 6 years of age | Do not use this product for children under 6 years of age, unless directed by a doctor. |
Other Information
• Each softgel contains 5 mg of Sodium.• Keep lid tightly closed.• Store at room temperature between 15°C to 30°C (59°F to 86°F).• Do not use if printed seal under cap is broken or missing.• For identification purposes, each softgel will have an imprint that reads NV13.
Inactive Ingredients
FD&C Red #40, FD&C Yellow #6, Gelatin, Glycerin, Ink (Edible), Polyethylene Glycol, Propylene Glycol, Purified Water, Sorbitol.
Package/Label Principal Display Panel
NDC 54629-600-01
Life-Line®
DOCUSATE SODIUM, USP
STOOL SOFTENER
100 mg Each
100 Softgels
Manufactured and Distributed by
National Vitamin Company
Casa Grande, AZ 85122
* Please review the disclaimer below.