Label: DULCOLAX- bisacodyl suppository
Contains inactivated NDC Code(s)
NDC Code(s): 54868-3155-1
- Packager: Physicians Total Care, Inc.
- This is a repackaged label.
- Source NDC Code(s): 0597-0052
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: OTC monograph not final
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.
Updated February 1, 2011
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- Drug Facts
For rectal use only
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 it may cause stomach discomfort, faintness, rectal burning and mild cramps
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
adults and children 12 years of age and over 1 suppository in a single daily dose. Peel open plastic. Insert suppository well into rectum, pointed end first. Retain about 15 to 20 minutes. children 6 to under 12 years of age 1/2 suppository in a single daily dose children under 2 years of age ask a doctor
- Other information
- Inactive ingredient
- PRINCIPAL DISPLAY PANEL
INGREDIENTS AND APPEARANCE
Product Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:54868-3155(NDC:0597-0052) Route of Administration RECTAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength bisacodyl (UNII: 10X0709Y6I) (bisacodyl - UNII:10X0709Y6I) bisacodyl 10 mg Inactive Ingredients Ingredient Name Strength HYDROGENATED COCONUT OIL (UNII: JY81OXM1OM) HYDROGENATED PALM KERNEL OIL (UNII: FM8D1RE2VP) Product Characteristics Color WHITE Score Shape BULLET Size Flavor Imprint Code Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:54868-3155-1 4 in 1 CARTON 1 4 in 1 BLISTER PACK Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph not final part334 03/17/2011 Labeler - Physicians Total Care, Inc. (194123980) Establishment Name Address ID/FEI Business Operations Physicians Total Care, Inc. 194123980 relabel