Ez2go Laxative Bisacodyl Capsule, Coated
FDA Label NDC 76470-059
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Valley Medical Products, Llc for the product Ez2go Laxative Bisacodyl (NDC 76470-059). 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 ingredients (in each tablet), purpose, uses, warnings, do not use:, ask a doctor before use if you have, when using this product, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Active Ingredients (In Each Tablet)
Bisacodyl USB 5 mg
Purpose
Stimulant laxative
Uses
- For temporary 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
- A sudden change in bowel habits that lasts more than 2 weeks
When Using This Product
- Do not chew or crush tablet(s)
- Do not use within 1 hour after taking an antacid or milk
- you may have stomach discomfort, faintness & cramps
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 laxative for more than 1 week
If Pregnant Or Breast-Feeding,
ask a health professional before use
Keep Out Of Reach Of Children.
In case of overdose, get medical help or contact a Poison Control Center right away
Directions
- Take with a glass of water
Adults and Children 12 years and over Take 1 to 3 tablets in a single dose daily Children 6 to under 12 years Take 1 tablet in a single daily dose Children under 6 years ask a doctor
Other Information
SEE BLISTER FOR EXPIRATION AND LOT NUMBER DO NOT USE IF BLISTER IS TORN OR SHOWS SIGNS OF TAMPERING
- Store at 25°C(77°F); excursions permitted between 15°-30°C(59°-86°F)
- Avoid excessive humidity
- See end flap for expiration date and lot number
Inactive Ingredients
acacia, ammonium hydroxide, calcium carbonate, carnauba wax, colloidal anhydrous silica, corn starch, D&C yellow #10 aluminum lake, FD&C yellow #6 aluminum lake, hypromellose, oron oxide black, lactose anhydrous, magnesium stearate, methylparaben, polydetrose,propylene glycol, polyvinyl acetate phthalate, povidone, propylene glycol, propylparaben, shellac glaze, simethicone, bicarbonate, stearic acid, sucrose, talc, titanium dioxide, triacetin, triethyl citrate
Questions Or Comments?
1-800-403-9832 or WWW.ez2go.com
Package Labeling:
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