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 Allegiant Health. 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(S)
Docusate sodium 100mg
Purpose
Stool softener
Use(S)
- 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
- stomach pain
- nausea
- vomiting
- notice a sudden change in bowel habits that lasts over 2 weeks
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 a laxative for more than 1 week
Pregnancy/Breastfeeding
ask a health professional before use.
Keep Out Of Reach Of Children
In case of accidental overdose, get medical help or contact a Poison Control Center (1-800-222-1222) right away.
Directions
Take only by mouth.
Adults and children 12 years and over: take 1 to 3 softgels daily. This dose may be taken as a single daily dose or in divided doses.
Children 2 to under 12 years of age: take 1 softgel daily
Children under 2 years of age: ask a doctor
Other Information
- each softgel contains: sodium 5mg
- VERY LOW SODIUM
- do not use if imprinted safety seal under cap is broken or missing
Storage
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
Call 1-888-952-0050 Monday to Friday 9am-5pm
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