Hyvee Regular Strength Stool Softener Softgel Capsule, Liquid Filled
FDA Label NDC 42507-108
10 label sections · Submitted to the FDA by Hyvee Inc · Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Hyvee Inc for the product Hyvee Regular Strength Stool Softener Softgel (NDC 42507-108). 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
Uses
• relieves occasional constipation (irregularity)
• generally produces bowel movement in 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
• stomach pain • nausea • vomiting • noticed a sudden change in bowel habits that lasts over 2 weeks
Stop use and ask a doctor if
• you have rectal bleeding or fail to have a bowel movement after use of a laxative. These could be signs of a serious condition • you need to use a stool softener laxative for more than1 week
If pregnant or breast-feeding, ask a health 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.
Directions
• take only by mouth • doses may be taken as a single daily dose or in divided doses.
| adults and children 12 years of age and over | take 1 to 3 softgels daily |
| children 2 to under 12 years of age | take 1 softgel daily |
| children under 2 years of age | ask a doctor |
Other Information
• each softgel contains: sodium 5 mg
• contains FD&C yellow no.6
• store at 20–25°C (68–77°F)
• keep bottle tightly closed
• protect from light, heat and moisture
• avoid excessive heat 40°C (104°F)
Inactive Ingredients
FD&C red no.40, FD&C yellow no.6, gelatin, glycerin, polyethylene glycol, propylene glycol, purified water, sorbitol sorbitan solution
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