Label: BISACODYL suppository
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NDC Code(s):
57896-443-01,
57896-443-05,
57896-443-12,
57896-443-55, view more57896-443-66
- Packager: GERI-CARE PHARMACEUTICAL CORP
- 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.
Drug Label Information
Updated November 23, 2022
If you are a consumer or patient please visit this version.
- Download DRUG LABEL INFO: PDF XML
- Official Label (Printer Friendly)
- SPL UNCLASSIFIED SECTION
- ACTIVE INGREDIENT
- PURPOSE
- INDICATIONS & USAGE
- WARNINGS
- ASK DOCTOR
- WHEN USING
- STOP USE
- PREGNANCY OR BREAST FEEDING
- KEEP OUT OF REACH OF CHILDREN
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DOSAGE & ADMINISTRATION
Directions
- tear off one suppository from the strip
- peel apart the wrapper
- continue peeling apart to almost the full length of the suppository (see illustration at the right)
- gently remove the suppository from the wrapper
- lie on your side and push suppository, with pointed end first, high into the rectum so it will not slip out
- retain it for about 15 to 20 minutes.
- Do not exceed recommended dose
- if suppository seems soft, place in refrigerator for a short time before use
adults and children 12 years and over
1 suppository once daily
children under 12 years Ask a doctor - STORAGE AND HANDLING
- INACTIVE INGREDIENT
- QUESTIONS
- PRINCIPAL DISPLAY PANEL
-
INGREDIENTS AND APPEARANCE
BISACODYL
bisacodyl suppositoryProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:57896-443 Route of Administration RECTAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength BISACODYL (UNII: 10X0709Y6I) (DEACETYLBISACODYL - UNII:R09078E41Y) BISACODYL 10 mg Inactive Ingredients Ingredient Name Strength FAT, HARD (UNII: 8334LX7S21) 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:57896-443-12 2 in 1 CARTON 11/01/2019 1 NDC:57896-443-66 6 in 1 BLISTER PACK; Type 0: Not a Combination Product 2 NDC:57896-443-05 10 in 1 CARTON 11/01/2019 2 NDC:57896-443-55 5 in 1 BLISTER PACK; Type 0: Not a Combination Product 3 NDC:57896-443-01 20 in 1 CARTON 11/01/2019 3 NDC:57896-443-55 5 in 1 BLISTER PACK; Type 0: Not a Combination Product Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph not final part334 11/01/2019 Labeler - GERI-CARE PHARMACEUTICAL CORP (611196254) Registrant - GERI-CARE PHARMACEUTICAL CORP (611196254)