Label: AVEDANA GENTLE LAXATIVE- bisacodyl suppository
- NDC Code(s): 43749-460-16, 43749-460-17
- Packager: Unipack, Inc.
- Category: HUMAN OTC DRUG LABEL
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 November 20, 2021
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- Active Ingredient (in each Suppository)
- Do not use
- Ask a doctor
- When using this product
- Stop use and ask a doctor
- If pregnant or breast-feeding
- Keep out of reach of children
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 suppository well into the rectum
-Do not use more than once per day
- Other information
- Inactive ingredient
INGREDIENTS AND APPEARANCE
AVEDANA GENTLE LAXATIVE
Product Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:43749-460 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 PALM KERNEL OIL (UNII: B0S90M0233) Product Characteristics Color white Score Shape BULLET Size 32mm Flavor Imprint Code Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:43749-460-16 4 in 1 CARTON 09/17/2017 1 NDC:43749-460-17 4 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 09/17/2017 Labeler - Unipack, Inc. (009248480) Establishment Name Address ID/FEI Business Operations Unipack, Inc. 009248480 manufacture(43749-460) , label(43749-460)