FDA Label for Docusate Sodium
View Indications, Usage & Precautions
Docusate Sodium Product Label
The following document was submitted to the FDA by the labeler of this product Rebel Distributors Corp. 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 Sodium 100mg
Purpose
Stool Softener
Keep Out Of Reach Of Children
In case of overdose, get medical help or contact a Poison Control center right way.
Uses
Prevents / relieves dry hard stool. Results usually occur 1 to 3 days after the first dose.
Warnings
Do not use for more than one week unless directed by a doctor.
Ask a doctor before use if you have abdominal pain, nausea, or vomiting; have noticed a sudden change in bowel habits that lasts over 2 weeks,; are taking mineral oil.
Stop use and ask a doctor if you have no bowel movement within 3 days; you have rectal bleeding. These could be signs of a serious condition.
If pregnant or breast-feeding, ask a health professional before use.
Tamper Evident: Do not use if imprinted seal under cap is missing or broken.
Directions
Adults and children 12 years and older: take 1-2 softgels daily until first bowel movement; 1 softgel daily thereafter, or as directed by a doctor.
Children under 12: consult a doctor.
Do not exceed recommended dose.
Other Information
Each softgel contains sodium 5mg.
Product from Canada or USA
Store at room temperature, 15°C-30°C (59°F-86°F)
Inactive Ingredients
may contain cirtic acid, D&C red no. 33, D&C yellow no. 10, ethyl vanillin, FD&C blue no. 1, FD&C re no. 40 FD&C yellow no. 6, gelatin, glycerin, edible ink, mannitol, methylparaben, polyethylene glycol, propylene glycol, propylparaben, sorbitol, water.
Distributed by:
Geri-Care Pharmaceuticals Corp.
Brooklyn, NY 11204
Repackaged by:
Rebel Distributors Corp
Thousand Oaks, CA 91320
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