FDA Label for Stool Softener
View Indications, Usage & Precautions
- OTHER
- ACTIVE INGREDIENT (IN EACH SOFTGEL)
- PURPOSE
- USE
- WARNINGS
- OTC - DO NOT USE
- ASK A DOCTOR BEFORE USE IF YOU HAVE
- STOP USE AND ASK A DOCTOR IF
- OTC - PREGNANCY OR BREAST FEEDING
- OTC - KEEP OUT OF REACH OF CHILDREN
- OVERDOSE WARNING
- DIRECTIONS
- OTHER INFORMATION
- INACTIVE INGREDIENTS
- QUESTIONS OR COMMENTS?
- PACKAGE LABEL.PRINCIPAL DISPLAY PANEL
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.
Other
Drug Facts
Active Ingredient (In Each Softgel)
Docusate Sodium 100 mg
Purpose
Stool softener laxative
Use
- for relief of occasional constipation and irregularity.
- This product generally produces bowel movement in 12 to 72 hours.
Warnings
Otc - Do Not Use
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 or vomiting
- a sudden change in bowel habits that lasts more than 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 to use a 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.
Overdose Warning
In case of overdose, get medical help or contact a Posion Control Center right away.
Directions
- take with a glass of water -see Overdose warning
adults and children 12 years of age and over | 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 | 1 softgel daily |
| children under 2 years of age | ask a doctor |
Other Information
- each softgel contains: sodium 5mg
- store at room temperature 15°-30° C (59°-86° F). Protect from excessive humidity
- contains FD&C Yellow No. 6
Inactive Ingredients
citric acid, FD&C red #40, FD&C yellow #6, gelatin, glycerin, polyethylene glycol, propylene glycol, sorbitol sorbitan solution, purified water and white edible ink
Questions Or Comments?
Call toll free: 1-855-215-8180
Package Label.Principal Display Panel
PuraVation Stool Softener
Docusate Sodium - 100 mg EACH
100 SOFTGELS
NDC 51013-819-01
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