FDA Label for Stool Softener

View Indications, Usage & Precautions

ACTIVE INGREDIENT (IN EACH CAPSULE)
PURPOSE
USES
WARNINGS - DO NOT USE
ASK A DOCTOR BEFORE USE IF
STOP USE AND ASK A DOCTOR IF
IF PREGNANT OR BREASTFEEDING
KEEP OUT OF REACH OF CHILDREN.
DIRECTIONS
OTHER INFORMATION
INACTIVE INGREDIENTS
QUESTIONS OR COMMENTS?
PRINCIPAL DISPLAY PANEL
PRODUCT LABEL

Stool Softener Product Label

The following document was submitted to the FDA by the labeler of this product Best Choice (valu Merchandisers Company). 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 Capsule)

Docusate Sodium 100 mg

Purpose

Stool softener

Uses

for the prevention of dry, hard stools
for relief of occasional constipation. This product generally produces a bowel movement within 12 to 72 hours.

Warnings - Do Not Use

if you are currently taking mineral oil, unless directed by a doctor
when abdominal pain, nausea or vomiting are present
for longer than 1 week, unless directed by a doctor

Ask A Doctor Before Use If

you notice a sudden change in bowel habits that persists over a period of 2 weeks

Stop Use And Ask A Doctor If

you have rectal bleeding
you fail to have a bowel movement after use

If Pregnant Or Breastfeeding

ask a health care professional before use.

Keep Out Of Reach Of Children.

In case of overdose, get medical help or contact a Poison Control Center right away.

Directions

adults and children 12 years of age and over: take 1- 3 capsules, preferably at bedtime
children 6 to 12 years of age: take 1 capsule at bedtime

Other Information

each capsule contains: sodium 6 mg
store at controlled room temperature 15^o - 30^o C (59^o- 86^o F)
do not use if imprinted safety seal under cap is broken or missing.
*This product is not manufactured or distributed by Purdue Pharma L.P., owner of the registered trademark Colace®

Inactive Ingredients

D&C Red #33, FD&C Red #40, FD&C Yellow #6, gelatin, glycerin, polyethylene glycol, propylene glycol, sorbitol special and titanium dioxide. May also contain: FD&C blue #1 and purified water.

Questions Or Comments?

Call toll free: 1-877-753-3935

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Compare to active ingredient in COLACE®*

stool softener

Docusate sodium 100 mg

KEEP OUTER CARTON FOR COMPLETE WARNINGS AND PRODUCT INFORMATION

Product Label