FDA Label for Extra Strength Stool Softener Laxative
View Indications, Usage & Precautions
Extra Strength Stool Softener Laxative Product Label
The following document was submitted to the FDA by the labeler of this product Aidapak Services, 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.
Otc - Active Ingredient
Active Ingredient (in each softgel)
Docusate Sodium 250 mg
Otc - Purpose
Purpose
Stool Softener
Indications & Usage
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.
Otc - Ask 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. These could be signs of a serious condition.
Otc - Pregnancy Or Breast Feeding
•ask a health professional before use. Keep out of reach of children. In case of overdose, get medical help or contact Poison Control Center right away.
Information For Patients
Directions:
Adults and children 12 years of age and over:
take 1 softgel daily or as directed by a doctor.
Children under 12 years of age: take as directed by doctor.
Other Information:
each softgel contains: sodium 15 mg.
Store between 15-30 C (59-86 F)
Inactive Ingredient
edible white ink, FD&C red 40, FD&C yellow 6, gelatin, glycerin, polyethylene glycol, propylene glycol, purified water and sorbitol special.
Package Label.Principal Display Panel
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