COCOA BUTTER, PHENYLEPHRINE HYDROCHLORIDE suppository

COCOA BUTTER, PHENYLEPHRINE HYDROCHLORIDE by

Drug Labeling and Warnings

COCOA BUTTER, PHENYLEPHRINE HYDROCHLORIDE by is a Otc medication manufactured, distributed, or labeled by Target Corporation, Pharma Pac, LLC. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ACTIVE INGREDIENT

Active ingredients (in each suppository)                                  Purpose


Cocoa Butter 85.5%........................................................................ Protectant
Phenylephrine HCL 0.25%............................................................... Vasoconstrictor

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

Keep out of reach of children. If swallowed, get
medical help or contact a Poison Control Center right away.

INDICATIONS & USAGE

Uses - shrinks hemorrhoidal tissues - relieves itching, burning and discomfort associated with hemorrhoids

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
______________________________________________________

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

Inactive Ingredients starch, shark liver oil, methylparaben, propylparaben

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

COCOA BUTTER, PHENYLEPHRINE HYDROCHLORIDE 
cocoa butter, phenylephrine hydrochloride suppository

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 11673-395
Route of Administration	RECTAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
COCOA BUTTER (UNII: 512OYT1CRR) (COCOA BUTTER - UNII:512OYT1CRR)	COCOA BUTTER	850 mg  in 1 g
PHENYLEPHRINE HYDROCHLORIDE (UNII: 04JA59TNSJ) (PHENYLEPHRINE - UNII:1WS297W6MV)	PHENYLEPHRINE	2.5 mg  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: 11673-395-60	12 in 1 CARTON
1		2.5 g in 1 PACKET

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part346	07/01/2011

Labeler - Target Corporation (006961700)

Registrant - Pharma Pac, LLC (140807475)

Establishment
Name	Address	ID/FEI	Business Operations
Pharma Pac, LLC		140807475	manufacture