Physicians Total Care, Inc. Dulcolax
Dulcolax by Physicians Total Care, Inc.
Dosage form: tablet, coated
Ingredients: bisacodyl 5mg Labeler: Physicians Total Care, Inc. NDC Code: 54868-0016
Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.
Dulcolax ® Tablets
Active ingredient (in each tablet)
Bisacodyl USP 5 mg .................................... Stimulant laxative
for temporary relief of occasional constipation and irregularity
this product generally produces bowel movement in 6 to 12 hours
if you cannot swallow without chewing Do not use
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)
it may cause stomach discomfort, faintness and cramps
do not use within 1 hour after taking an antacid or milk
Stop use and ask a doctor if
you have rectal bleeding or no 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
, ask a health professional before use. If pregnant or breast-feeding
In case of overdose, get medical help or contact a Poison Control Center right away. Keep out of reach of children.
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 2 years of age ask a doctor
store at 20-25°C (68-77°F
protect from excessive humidity
acacia, acetylated monoglyceride, carnauba wax, cellulose acetate phthalate, corn starch, dibutyl phthalate, docusate sodium, gelatin, glycerin, iron oxides, kaolin, lactose, magnesium stearate, methylparaben, pharmaceutical glaze, polyethylene glycol, povidone, propylparaben, Red No. 30 lake, sodium benzoate, sorbitan monooleate, sucrose, talc, titanium dioxide, white wax, Yellow No. 10 lake
Dulcolax (bisacodyl USP) laxative tablets
bisacodyl tablet, coated
Product Type HUMAN OTC DRUG Item Code (Source) NDC:54868-0016(NDC:0597-0012)
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
bisacodyl (bisacodyl) bisacodyl 5 mg
Ingredient Name Strength
Color ORANGE Score no score
Shape ROUND Size 5mm
Flavor Imprint Code 12;
# Item Code Package Description
1 NDC:54868-0016-0 1 BLISTER PACK (BLISTER PACK) in 1 CARTON
1 10 TABLET, COATED (TABLET) in 1 BLISTER PACK
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
OTC monograph not final part334 05/19/2010
Labeler - Physicians Total Care, Inc.
Name Address ID/FEI Operations
Physicians Total Care, Inc. 194123980 relabel
Physicians Total Care, Inc.
Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.
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