FDA Label for Preferred Stool Softener
View Indications, Usage & Precautions
Preferred Stool Softener Product Label
The following document was submitted to the FDA by the labeler of this product Reese Pharmaceutical Co. 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
Docusate Calcium 240 mg
Purpose
Stool Softener
Uses
- For the 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 one week unless directed by a doctor.
Ask A Doctor Before Use
■ stomach pain ■ nausea ■ vomiting ■ noticed a sudden change in bowel habits that lasts over 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 healthcare professional before use.
Keep Out Of Reach Of Children.
In case of accidental overdose, get medical help or contact a Poison Control Center (1-800-222-1222) right away.
Directions
Adults and Children over 12 years of age
Take orally 1 softgel daily for 2 to 3 days or until bowl movements are normal, or as directed by a doctor.
Children under 12 years of age
Do not use this product for children under 12 years of age, unless directed by a doctor.
Other Information
- Store at room temperature between 15°C to 25°C (59°F to 77°F).
- Do not use if either seal is broken or missing.
Inactive Ingredients
FD&C Blue #1, FD&C Red #40, Gelatin, Glycerin, Sorbitol Special.
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