Purpose
Bisacodyl (USP) 5 mg.......................................................................................................................Stimulant laxative
Dulcolax Simulant Laxative Tablet, Film Coated
FDA Label NDC 41167-0101
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Chattem, Inc. for the product Dulcolax Simulant Laxative (NDC 41167-0101). 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 purpose, use, 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,, keep out of reach of children., and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Use
● 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
● 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.
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 of age and over 1 to 3 tablets in a single daily dose
children 6 to under 12 years of age 1 tablet in a single daily dose
children under 6 years of age ask a doctor
Other Information
● do not use if individual blister unit is open or torn
● store at 20°-25°C (68°-77°F)
● protect from excessive humidity
Inactive Ingredients
acacia gum, ammonium hydroxide, beeswax, carnauba wax, corn starch, D&C red #30 aluminum lake, D&C yellow #10 aluminum lake, glycerin, glyceryl monostearate, iron oxides, lactose monohydrate, magnesium stearate, methacrylic acid ethyl acrylate copolymer, methylparaben, modified starch, polyethylene glycol 6000, polysorbate 80, povidone, propylene glycol, propylparaben, shellac, sodium benzoate, sucrose, talc, titanium dioxide, triethyl citrate
Questions?
Call 1-866-844-2798 or visit www.Dulcolax.com
Keep carton as it contains important product information.
Principal Display Panel
OVERNIGHT RELIEF
Dulcolax
LAXATIVE
25 comfort coated Tablets
Principal Display Panelovernight Reliefdulcolaxlaxative25 Comfort Coated Tablets (Dulcolax Stimulant Laxative Cmp Cha 01)
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