Active Ingredient (In Each Tablet)
Bisacodyl USP, 5 mg
Laxative Tablet, Delayed Release
FDA Label NDC 80513-409
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Advanced Rx Llc for the product Laxative (NDC 80513-409). 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 tablet), purpose, uses, do not use, ask a doctor before use if you have, when using this product, stop use and ask a doctor if, if pregnant or breast-feeding,, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Purpose
Stimulant laxative
Uses
- for relief of occasional constipation and irregularity
- this product generally produces bowel movement in 6 to 12 hours
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
- it may cause stomach discomfort, faintness, and 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
- do not take more than directed
- take with a glass of water
| adults and children 12 years and over | take 1 to 3 tablets in a single daily dose |
| children 6 to under 12 years | take 1 tablet in a single daily dose |
| children under 6 years | ask a doctor
|
Other Information
- TAMPER EVIDENT: DO NOT USE IF IMPRINTED SAFETY SEAL UNDER CAP IS BROKEN OR MISSING
- store at 25°C (77°F); excursions permitted between 15°-30°C (59°-86°F)
- avoid excessive humidity
- use by expiration date on package
Inactive Ingredients
Colloidal silicon dioxide, Hypromellose-5, Magnesium stearate, Maltodextrin, Methacrylic acid, Microcrystalline cellulose, Neelicert FD&C Yellow 10 Al Lake, Neelicert FD&C Yellow 6 Al Lake, PEG 400, Purified Water, Sodium Starch Glycolate, Talc, Titanium Dioxide, Triethyl citrate.
Questions Or Comments?
1-800-630-8895
Distributed By
ADVANCED RX LLC
1942 NE 163rd St.North Miami Beach,
FL 33162 U.S.A.
Package Label.Principal Display Panel
NDC 80513-409-20
*Compare to Dulcolax ® Laxative Tablets Active Ingredient
Laxative
Bisacodyl USP 5 mg
Gentle Predictable
Overnight Relief
200 Comfort Coated Tablets
*This product is not manufactured or distributed by the owner of the registered trademark Dulcolax ®.
Labels (Label)
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