Hyvee Stimulant Laxative Tablet
FDA Label NDC 42507-167
Full FDA labeling including 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 Stimulant Laxative (NDC 42507-167). 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 tablet), purpose, use, 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 Tablet)
Bisacodyl USP 5 mg
Purpose
Stimulant laxative
Use
• for relief of occasional constipation and irregularity • this product generally produces bowel movement in 6 to 12 hours
Warnings
Do not use • if you cannot swallow without chewing.
Ask a doctor before use if you have
• stomach pain, nausea or vomiting
• noticed a sudden change in bowel habits that lasts more than 2 weeks
When using this product
• it may cause stomach discomfort, faintness and cramps • do not chew or crush tablet(s) • do not use within 1 hour after taking an antacid or milk
Stop use and ask a doctor if
• you have rectal bleeding or fail to have a bowel movement after using this product. These could 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 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
• do not take more than directed
• take with a glass of water
Other Information
• contains FD&C yellow no. 6
• store at 20-25°C (68-77°F)
• protect from light, heat and moisture
Inactive Ingredients
acacia gum, calcium carbonate, croscarmellose sodium, D&C yellow no. 10, dibasic calcium phosphate, FD&C yellow no. 6, gelatin, glycerol monostearate, hypromellose, iron oxide red, magnesium stearate, methacrylic acid copolymer, microcrystalline cellulose, polyethylene glycol, precipitated silica, silicon dioxide, sodium methylparaben, sodium propylparaben, sodium starch glycolate, starch, sucrose, talc, titanium dioxide, triethyl citrate
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Packaging
Hyvee Stimulant Laxative (42507167 4)
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