FDA Label for Dulcolax Stimulant Laxative
View Indications, Usage & Precautions
Dulcolax Stimulant Laxative Product Label
The following document was submitted to the FDA by the labeler of this product Chattem, Inc.. The document includes published materials associated whith this product with the essential scientific information about this product as well as other prescribing information. Product labels may durg indications and usage, generic names, contraindications, active ingredients, strength dosage, routes of administration, appearance, warnings, inactive ingredients, etc.
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
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
● contains FD&C Yellow No. 6
● 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 senegal gum, ammonium hydroxide, calcium carbonate, carnauba wax, colloidal anhydrous silica, corn starch, D&C yellow #10 aluminum lake, FD&C yellow #6 aluminum lake, hypromellose, iron oxides, lactose, magnesium stearate, methylparaben, polydextrose, polyethylene glycol, polyvinyl acetate phthalate, povidone, propylene glycol, propylparaben, shellac, simethicone, sodium alginate, sodium benzoate, sodium bicarbonate, stearic acid, sucrose, talc, titanium dioxide, triacetin, triethyl citrate
Questions?
Call 1-866-844-2798 or visit www.Dulcolax.com
Keep carton as it contains important product information.
Principal Display Panel
Dulcolax
LAXATIVE
200 TABLETS
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