NDC | 63868-360-08 |
Set ID | 82426b60-53f7-4d3b-8a40-8fbcdd1c4199 |
Category | HUMAN OTC DRUG LABEL |
Packager | Chain Drug Marketing Association |
Generic Name | |
Product Class | |
Product Number | |
Application Number | PART334 |
- Active ingredient
- Purpose
- Uses
- Warnings
- ASK DOCTOR
- When using this product
- STOP USE
- PREGNANCY OR BREAST FEEDING
- Keep out of reach of children
-
Directions
Adults and children 12 years of age and older Children 6 to under 12 years Children under 6
One suppository once daily 1/2 suppository once daily Ask doctor.
-Detach one suppository from the strip and remove from foil - Carefully insert one suppositry well into the rectum
-Do not use more than once per day
- Other Information
- Inactive Ingredients
- PRINCIPAL DISPLAY PANEL
-
INGREDIENTS AND APPEARANCE
QUALITY CHOICE GENTLE LAXATIVE
bisacodyl suppositoryProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:63868-360 Route of Administration RECTAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength BISACODYL (UNII: 10X0709Y6I) (DEACETYLBISACODYL - UNII:R09078E41Y) BISACODYL 10 mg in 2000 mg Inactive Ingredients Ingredient Name Strength FAT, HARD (UNII: 8334LX7S21) 1990 mg in 2000 mg Product Characteristics Color white Score Shape BULLET Size 34mm Flavor Imprint Code Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:63868-360-08 2 in 1 CARTON 11/16/2015 1 40 mg 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 02/13/2015 Labeler - Chain Drug Marketing Association (011920774) Registrant - Reese Pharmaceutical Co (004172052) Establishment Name Address ID/FEI Business Operations Reese Pharmaceutical Co 004172052 relabel(63868-360) , repack(63868-360) Establishment Name Address ID/FEI Business Operations Biopharm 801652546 manufacture(63868-360)