NDC | 59779-401-44, 59779-401-45, 59779-401-46 |
Set ID | 79aba427-9500-4689-a2a3-c8128eb08398 |
Category | HUMAN OTC DRUG LABEL |
Packager | CVS |
Generic Name | |
Product Class | alpha-1 Adrenergic Agonist |
Product Number | |
Application Number | PART346 |
- ACTIVE INGREDIENT
-
PURPOSE
Active ingredients (in each suppository) Purpose
Cocoa Butter 85.5%........................................................................ Protectant
Phenylephrine HCL 0.25%............................................................... Vasoconstrictor
________________________________________________________________________________________
Uses temporarily - Shrinks hemorrhoidal tissues - relieves itching, burning and discomfort associated with hemorrhoids - KEEP OUT OF REACH OF CHILDREN
- INDICATIONS & USAGE
-
WARNINGS
Warnings
For rectal use only
____________________________________________________
Ask a doctor before use if you have - heart disease - high blood pressure
- thyroid disease - diabetes - difficulty in urination due to enlargement of the prostate gland
_____________________________________________________
Ask a doctor or pharmacist before use if you are - presently taking a prescription
drug for high blood pressure or depression
______________________________________________________
Stop use and ask a doctor if
- bleeding occurs - condition gets worse or does not improve within 7 days
______________________________________________________
If pregnant or breastfeeding, ask a health professional before use
_______________________________________________________________
Keep out of reach of children. If swallowed, get
medical help or contact a Poison Control Center
right away
______________________________________________________
-
DOSAGE & ADMINISTRATION
Directions
- Adults - if possible, clean the affected area by patting or blotting with an appropriate cleansing pad
- gently dry by patting or blotting with toilet tissue or a soft cloth before insertion of this product
- detach one suppository from strip - remove wrapper before inserting into the rectum - hold suppository
with rounded end up and carefully peel film slowly and evenly down both sides to expose the suppository
- insert one suppository into rectum up to 4 times daily especially at night and morning or after each bowel
movement
Children under 12 years of age: ask a doctor
________________________________________________________________________________________
Other information - store at room temperature but not over 89 degrees F (32 degrees C) - INACTIVE INGREDIENT
- PRINCIPAL DISPLAY PANEL
-
INGREDIENTS AND APPEARANCE
COCOA BUTTER, PHENYLEPHRINE HYDROCHLORIDE
cocoa butter, phenylephrine hydrochloride suppositoryProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:59779-401 Route of Administration RECTAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength COCOA BUTTER (UNII: 512OYT1CRR) (COCOA BUTTER - UNII:512OYT1CRR) COCOA BUTTER .855 g in 1 g PHENYLEPHRINE HYDROCHLORIDE (UNII: 04JA59TNSJ) (PHENYLEPHRINE - UNII:1WS297W6MV) PHENYLEPHRINE .0025 g in 1 g Inactive Ingredients Ingredient Name Strength SHARK LIVER OIL (UNII: 4B24275HEU) STARCH, CORN (UNII: O8232NY3SJ) METHYLPARABEN (UNII: A2I8C7HI9T) PROPYLPARABEN (UNII: Z8IX2SC1OH) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:59779-401-44 30 g in 1 BOX 2 NDC:59779-401-45 60 g in 1 BOX 3 NDC:59779-401-46 120 g in 1 BOX Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph final part346 07/01/2011 Labeler - CVS (062312574) Registrant - Pharma Pac, LLC (140807475) Establishment Name Address ID/FEI Business Operations Pharma Pac, LLC 140807475 manufacture