FDA Label for Stool Softener Extra Strength
View Indications, Usage & Precautions
Stool Softener Extra Strength Product Label
The following document was submitted to the FDA by the labeler of this product Atlantic Biologicals Corps. 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 Softgel)
Docusate Sodium 250 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 more 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 Breast-Feeding,
ask a health 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
- take 1 softgel daily or as directed by a doctor
adults and children over 12 years of age and over:
- : take as directed by a doctor children under 12 years of age
Other Information
- sodium 15 mg each softgel contains:
- store at controlled room temperature 15 - 30 C (59 - 86 F) oooo
- do not use if imprinted safety seal under cap is broken or missing
Inactive Ingredients
edible white ink, FD&C Red No# 40, FD&C Yellow No# 6, gelatin, glycerin, polyethylene glycol, propylene glycol, purified water and sorbitol special.
Questions Or Comments?
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