Docusate Sodium Capsule, Liquid Filled
FDA Label NDC 0904-7609
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Major Pharmaceuticals for the product Docusate Sodium (NDC 0904-7609). 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 drug facts, active ingredient (in each softgel), purpose, uses, warnings, otc - keep out of reach of children, directions, other information, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Active Ingredient (In Each Softgel)
Docusate Sodium 100 mg
Purpose
Stool softener laxative
Uses
• relieves occasional constipation (irregularity)
• this product generally produces a bowel movement within 12 to 72 hours.
Warnings
Do not use
• if you are presently taking mineral oil, unless told to do so by a doctor
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 only by mouth • take softgels 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 by a doctor. This dose may be taken as a single daily dose or in divided doses. |
| 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 5 mg (very low sodium)
• store at controlled room temperature 20–25°C (68–77°F)
• protect from light, heat and moisture
Inactive Ingredients
FD&C Red No.40, FD&C Yellow No.6, gelatin, glycerin, polyethylene glycol 400, propylene glycol, purified water, sorbitol sorbitan solution
Questions Or Comments?
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Packaging
Major Docusate Sodium Stool Softener Laxative (09047609 1)
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