Label: BISACODYL suppository
Contains inactivated NDC Code(s)
NDC Code(s): 68784-102-01, 68784-102-08, 68784-102-12, 68784-102-16
- Packager: Acino Products, LLC
- 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 July 14, 2014
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- Drug Facts Active Ingredients (per suppository)
- Keep out of reach of children
- Do not use laxative products
- Ask a doctor before use if you have
- When using this product
- Stop use and ask a doctor if
- If pregnant or breast-feeding
- Other information
- Inactive ingredient
BISACODYL Laxative Suppository Label
COMPARE TO THE ACTIVE INGREDIENT IN DULCOLAX® SUPPOSITORIES
FAST RELIEF OF TEMPORARY CONSTIPATION OFTEN IN 15 MINUTES TO 1 HOUR
16 SUPPOSITORIES (10 mg each)
TAMPER-EVIDENT: FOR YOUR SAFETY, SUPPOSITORIES ARE PACKED IN TAMPER-EVIDENT SEALED WRAPPER.
DO NOT USE IF WRAPPER IS TORN OR OPEN.
This product is not manufactured or distributed by Boehringer Ingelheim Consumer Healthcare Products, Inc., owner of the registered trademark Dulcolax®
ACINO PRODUCTS, LLC
681 MAIN ST. BLDG. 27
BELLEVILLE, NJ 07109
MADE IN USA
INGREDIENTS AND APPEARANCE
Product Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:68784-102 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 FAT, HARD (UNII: 8334LX7S21) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:68784-102-08 8 in 1 BOX 1 1 in 1 BLISTER PACK 2 NDC:68784-102-12 12 in 1 BOX 2 1 in 1 BLISTER PACK 3 NDC:68784-102-16 16 in 1 BOX 3 1 in 1 BLISTER PACK 4 NDC:68784-102-01 100 in 1 BOX 4 1 in 1 BLISTER PACK Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph not final part334 01/01/2005 Labeler - Acino Products, LLC (019385518) Registrant - Acino Products, LLC (019385518) Establishment Name Address ID/FEI Business Operations Acino Products, LLC 019385518 manufacture(68784-102)