Label: COCOA BUTTER, PHENYLEPHRINE HYDROCHLORIDE suppository
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Contains inactivated NDC Code(s)
NDC Code(s): 59779-401-44, 59779-401-45, 59779-401-46 - Packager: CVS
- 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 July 1, 2011
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- Official Label (Printer Friendly)
- ACTIVE INGREDIENT
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PURPOSE
Active ingredients (in each suppository) Purpose
Cocoa Butter 85.5%........................................................................ Protectant
Phenylephrine HCL 0.25%............................................................... Vasoconstrictor
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Uses temporarily - Shrinks hemorrhoidal tissues - relieves itching, burning and discomfort associated with hemorrhoids
- KEEP OUT OF REACH OF CHILDREN
- INDICATIONS & USAGE
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WARNINGS
Warnings
For rectal use only
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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
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Ask a doctor or pharmacist before use if you are - presently taking a prescription
drug for high blood pressure or depression
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Stop use and ask a doctor if
- bleeding occurs - condition gets worse or does not improve within 7 days
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If pregnant or breastfeeding, ask a health professional before use
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Keep out of reach of children. If swallowed, get
medical help or contact a Poison Control Center
right away
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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
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Other information - store at room temperature but not over 89 degrees F (32 degrees C) - INACTIVE INGREDIENT
- PRINCIPAL DISPLAY PANEL
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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
