FDA Label for Topcare Stool Softener
View Indications, Usage & Precautions
Topcare Stool Softener Product Label
The following document was submitted to the FDA by the labeler of this product Topco Associates, 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(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
you have
- stomach pain
- nausea
- vomiting
- noticed a sudden change in bowel habits that lasts over a period of 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 stool softener 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. 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 capsule contains: sodium 5mg
- VERY LOW SODIUM
Storage
- store 25°C (77°F) excursions permitted between 15°– 30°C (59°–86°F)
Inactive Ingredients
Black edible ink, citric acid, D&C red #33, FD&C blue #1, FD&C red #40, FD&C yellow #6, gelatin, glycerin, polyethylene glycol, propylene glycol, purified water, sorbitol special
Questions
Call 1-888-952-0050 Monday through Friday 9am-5pm
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