Active Ingredient
Docusate Sodium 100mg
Docusate Sodium
FDA Label NDC 21695-590
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 Sodium (NDC 21695-590). 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, purpose, keep out of reach of children, uses, warnings, directions, other information, inactive ingredients, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
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
Package/Label Principal Display Panel
Docusate Sodium 100mg (7e23b026 Fee4 436a B378 33d31d6d8b40 01)
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