Active Ingredient (In Each Softgel)
Docusate Sodium 100 mg
Docusate Sodium - Stool Softener Laxative Capsule, Liquid Filled
FDA Label NDC 55154-3369
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Cardinal Health 107, Llc for the product Docusate Sodium - Stool Softener Laxative (NDC 55154-3369). 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 (in each softgel), purpose, uses, warnings, otc - keep out of reach of children, 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 laxative
Uses
• for relief of occasional constipation (irregularity)
• This generally produces a bowel movement within 12 to 72 hours.
Warnings
Ask a doctor before use if you have
• abdominal pain, nausea, or vomiting
• a sudden change in bowel habits that lasts over 14 days
Ask a doctor or pharmacist before use if you are presently taking mineral oil
Stop use and ask a doctor if
• you have rectal bleeding or no bowel movement after using this product.
These can be signs of a serious condition
• you need to use a laxative for more than 1 week
If pregnant or breast-feeding, ask a health care professional before use.
Otc - Keep Out Of Reach Of Children
Keep out of reach of children
Overdose Warning: In case of overdose, get medical help or contact a Poison Control Center right away (1-800-222-1222). Prompt medical attention is critical for adults as well as children even if you do not notice any signs or symptoms.
Directions
• take softgel with a full glass (8 oz) of water
adults and children 12 years of age and older | take 1 to 3 softgels daily or as directed |
children 6 to under 12 years of age | take 1 softgel daily or as directed by a doctor |
children under 6 years of age | ask a doctor |
Other Information
• each softgel contains: sodium 10 mg (very low sodium)
• store at 25°C (77°F) in a dry place. Avoid excessive heat 40°C (140°F).
Inactive Ingredients
edible white ink, FD&C red no. 40, FD&C yellow no. 6, gelatin, glycerin, isopropyl alcohol, light mineral oil, medium chain triglycerides, polyethylene glycol, propylene glycol, purified water, sorbitol sorbitan solution
Questions Or Comments?
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Distributed by:
MAJOR® PHARMACEUTICALS
Livonia, MI 48152
Distributed By:
Cardinal Health
Dublin, OH 43017
L57466801221
Product of UAE
Packaged and Quality Assured in the USA
TAMPER EVIDENT: DO NOT USE IF PACKAGE IS OPENED OR IF BLISTER UNIT IS TORN, BROKEN OR SHOWS ANY SIGNS OF TAMPERING
Principal Display Panel
Docusate Sodium
100 mg
10 Softgels
Bag Label (Image 01)
* Please review the disclaimer below.
