Label: HEMORRHOIDAL- cocoa butter, phenylephrine hydrochloride suppository
-
Contains inactivated NDC Code(s)
NDC Code(s): 63868-208-12, 63868-208-24 - Packager: Chain Drug Marketing Association, Inc.
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: OTC monograph 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 May 19, 2021
If you are a consumer or patient please visit this version.
- Download DRUG LABEL INFO: PDF XML
- Official Label (Printer Friendly)
- Active Ingredients
- Purposes
- KEEP OUT OF REACH OF CHILDREN
- Uses
- Warnings
- Ask a doctor or pharmacist before use if you are
- Ask a doctor before use if you have
- When using this product
- If pregnant or breast-feeding
- Directions Adults
- Other Information
- Inactive ingredients
- PRINCIPAL DISPLAY PANEL
-
INGREDIENTS AND APPEARANCE
HEMORRHOIDAL
cocoa butter, phenylephrine hydrochloride suppositoryProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:63868-208 Route of Administration RECTAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength COCOA BUTTER (UNII: 512OYT1CRR) (COCOA BUTTER - UNII:512OYT1CRR) COCOA BUTTER 1768.8 mg PHENYLEPHRINE HYDROCHLORIDE (UNII: 04JA59TNSJ) (PHENYLEPHRINE - UNII:1WS297W6MV) PHENYLEPHRINE HYDROCHLORIDE 5 mg Inactive Ingredients Ingredient Name Strength METHYLPARABEN (UNII: A2I8C7HI9T) PROPYLPARABEN (UNII: Z8IX2SC1OH) STARCH, CORN (UNII: O8232NY3SJ) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:63868-208-12 12 in 1 BOX 05/18/2021 1 1 in 1 BLISTER PACK; Type 0: Not a Combination Product 2 NDC:63868-208-24 24 in 1 BOX 05/18/2021 2 1 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 final part346 09/26/2007 Labeler - Chain Drug Marketing Association, Inc. (011920774) Registrant - Acino Products, LLC. (019385518) Establishment Name Address ID/FEI Business Operations Acino Products, LLC. 019385518 manufacture(63868-208)