Active Ingredient(S)
Docusate Calcium
Docusate Calcium
FDA Label NDC 21695-980
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Rebel Distributors Corp for the product Docusate Calcium (NDC 21695-980). This document serves as the official prescribing information, containing essential scientific data and clinical materials required for healthcare providers and patients.
This specific version of the label includes detailed information regarding active ingredient(s), purpose, use(s), do not use, ask a doctor before use if, ask a doctor or pharmacist before use if, stop use and ask a doctor if, pregnancy/breastfeeding, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Purpose
Stool Softener
Use(S)
for relief of occasional constipation. This product generally produces a bowel movement within 12 to 72 hours.
Do Not Use
-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.
Ask A Doctor Or Pharmacist 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
Pregnancy/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 over 12 years of age: take 1 softgel daily for several days, or until bowel movements are normal, or as directed by a doctor
-children under 12 years of age: take as directed by a doctor
Other Information
-do not use if imprinted safety seal under cap is broken or missing
-This product is not manufactured or distributed by Chattem, Inc., owner of the registered trademark Surfak Stool Softener
Storage
Store at controlled room temperature 15 degrees-30 degrees C (59 degrees-86 degrees F)
Inactive Ingredients
Corn oil, D&C Red #33, FD&C Red #40, gelatin, glycerin, purified water and sorbitol special.
Questions
Adverse Drug Event Call: (800) 616-2471
Distributed by: Rugby Laboratories, Inc. Duluth GA 30097
Repackaged by: Rebel Distributors Corp Thousand Oaks, CA 91320
Principal Display Panel
Docusate Calcium Softgel Capsules
240mg
Docusate Calcium 240mg (F5480c36 4401 49f2 B550 912e01527ac8 01)
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