FDA Label for Stool Softener
View Indications, Usage & Precautions
Stool Softener Product Label
The following document was submitted to the FDA by the labeler of this product Puracap Pharmaceutical Llc. 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
- for relief of occasional constipation (irregularity)
- this product generally produces a bowel movement in 12 to 72 hours
Ask A Doctor Before Use If You Have
- stomach pain, nausea, or vomiting
- a sudden change in bowel habits that lasts over 14 days
Stop Use And Ask A Doctor If
- you have rectal bleeding or no bowel movement after using this product. These could be signs of a serious condition.
- you need to use a laxative for more than 1 week
Directions
take softgels with a full glass (8oz) of water
adults and children 12 years and older | take 1 to 3 softgels daily or as directed by a doctor. This dose may be taken as a single daily dose or in divided doses. |
children 6 to under 12 years | take 1 softgel daily or as directed by a doctor |
children under 6 years | ask a doctor |
Other Information
- each softgel contains: sodium 5 mg
- store at room temperature 15°-30°C (59°-86°F)
- protect from excessive humidity
Inactive Ingredients
anhydrous citric acid, FD&C red # 40, FD&C yellow #6, gelatin, glycerin, polyethylene glycol, propylene glycol, purified water, sorbitol sorbitan solution and white edible ink
Questions Or Comments?
Call toll free: 1-855-215-8180
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Stool Softener
DOCUSATE SODIUM 100 mg 30 SOFTGELS
Compare to Phillips' Stool Softener Liquid Gels active ingredient
NDC 51013-433-20
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