RxNorm Names
DULCOLAX
(bisacodyl)
tablet, coated
[Boehringer Ingelheim Pharmaceuticals Inc.]
Permanent Link:
http://dailymed.nlm.nih.gov/dailymed/lookup.cfm?setid=1cf7ab57-2a41-ee23-c2a7-c53551da9643| Category | DEA Schedule | Marketing Status |
|---|---|---|
| HUMAN OTC DRUG LABEL | OTC monograph not final |
NOTE: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.
| Drug Facts | |
| Active ingredient (in each tablet) | Purpose |
| 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
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
- 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
- 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
Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center right away.
| adults and children 12 years 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 |
Inactive ingredients
acacia, ammonium hydroxide, calcium carbonate, carnauba wax, corn starch, D&C Red # 27 aluminum lake, FD&C Blue # 2 aluminum lake, FD&C Yellow #6 aluminum lake, hypromellose, iron oxide black, lactose, magnesium stearate, methylparaben, polydextrose, polyethylene glycol, polyvinyl acetate phthalate, povidone, propylene glycol, propylparaben, shellac, silica, simethicone, sodium alginate, sodium benzoate, sodium bicarbonate, stearic acid, sucrose, talc, titanium dioxide, triacetin, triethyl citrate
| DULCOLAX
bisacodyl tablet, coated |
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| Labeler - Boehringer Ingelheim Pharmaceuticals Inc. (603175944) |
| Registrant - Boehringer Ingelheim Pharmaceuticals Inc. (603175944) |
| Establishment | |||
| Name | Address | ID/FEI | Business Operations |
| LNK International, Inc. | 038154464 | MANUFACTURE(0597-0150) | |
Revised: 03/2012
Document Id: 8d78e8ed-c1fb-4490-890e-d27aaa8e629d
Set id: 1cf7ab57-2a41-ee23-c2a7-c53551da9643
Version: 2
Effective Time: 20120322
Boehringer Ingelheim Pharmaceuticals Inc.
Review RxNorm Normal Forms