FDA Label for Stool Softener
View Indications, Usage & Precautions
- OTHER
- OTC - ACTIVE INGREDIENT
- OTC - PURPOSE
- INDICATIONS & USAGE
- WARNINGS
- OTC - DO NOT USE
- OTC - ASK DOCTOR
- OTC - STOP USE
- OTC - PREGNANCY OR BREAST FEEDING
- OTC - KEEP OUT OF REACH OF CHILDREN
- DOSAGE & ADMINISTRATION
- OTHER SAFETY INFORMATION
- INACTIVE INGREDIENT
- OTC - QUESTIONS
- PACKAGE LABEL.PRINCIPAL DISPLAY PANEL
Stool Softener Product Label
The following document was submitted to the FDA by the labeler of this product Bjwc (berkley & Jensen / Bj's). 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.
Other
Drug Facts
Otc - Active Ingredient
Active ingredient (in each softgel)
Docusate sodium USP 100 mg
Otc - Purpose
Purpose
Stool softener
Indications & Usage
Uses:
- relieves occasional constipation (irregularity)
- generally produces bowel movement in 12 to 72 hours
Warnings
Warnings
Otc - Do Not Use
Do not use
- if you are presently taking mineral oil, unless told to do so by a doctor
Otc - Ask 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
Otc - Stop Use
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
Otc - Pregnancy Or Breast Feeding
If pregnant or breast-feeding, ask a health professional before use.
Otc - Keep Out Of Reach Of Children
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).
Dosage & Administration
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
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 Safety Information
Other information
- each capsule contains: sodium 6 mg
- keep tightly closed.
- store at 25°C (77°F); excursions permitted between 15°-30°C (59°-86°F).
Inactive Ingredient
Inactive ingredients D&C red no. 33, FD&C blue no. 1, FD&C red no. 40, FD&C yellow no. 6, ferrosoferric oxide, gelatin, glycerin, polyethylene glycol 400, propylene glycol, purified water, shellac, sorbitol solution, titanium dioxide
Otc - Questions
Questions or comments? Call 1-877-290-4008
Package Label.Principal Display Panel
730T Docusate Sodium 100mg 400ct
* Please review the disclaimer below.
