Label: HEMORRHOIDAL- cocoa butter, phenylephrine hydrochloride suppository
-
Contains inactivated NDC Code(s)
NDC Code(s): 70795-1021-2, 70795-1021-4 - Packager: GRAXCELL PHARMACEUTICAL, LLC
- 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 December 21, 2021
If you are a consumer or patient please visit this version.
- Download DRUG LABEL INFO: PDF XML
- Official Label (Printer Friendly)
- Active Ingredients (per suppository)
- Purpose
- Uses
-
Warnings
For rectal use only
Ask a doctor or pharmacist before use if you are
presently taking a prescription drug for high blood pressure or depression
Ask a doctor before use if you have
- heart disease
- thyroid disease
- high blood pressure
- diabetes
- difficulty in urination due to enlargement of the prostate gland
- 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:70795-1021 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:70795-1021-2 12 in 1 BOX 03/29/2017 1 1 in 1 BLISTER PACK; Type 0: Not a Combination Product 2 NDC:70795-1021-4 24 in 1 BOX 04/22/2017 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 03/29/2017 Labeler - GRAXCELL PHARMACEUTICAL, LLC (056556923) Registrant - GRAXCELL PHARMACEUTICAL, LLC. (056556923)