The following Structured Product Label (SPL) was submitted to the FDA by Target Corporation for the product Cocoa Butter, Phenylephrine Hydrochloride (NDC 11673-395). This document serves as the official prescribing information, containing essential scientific data and clinical materials required for healthcare providers and patients.
This specific version of the label includes detailed information regarding otc - active ingredient, otc - purpose, otc - keep out of reach of children, indications & usage, warnings, dosage & administration, inactive ingredient, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Otc - Active Ingredient
Active ingredients (in each suppository) PurposeCocoa Butter 85.5%........................................................................ ProtectantPhenylephrine HCL 0.25%............................................................... Vasoconstrictor
Otc - Purpose
Active ingredients (in each suppository) PurposeCocoa Butter 85.5%........................................................................ ProtectantPhenylephrine HCL 0.25%............................................................... Vasoconstrictor________________________________________________________________________________________Uses temporarily - Shrinks hemorrhoidal tissues - relieves itching, burning and discomfort associated with hemorrhoids
Otc - 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____________________________________________________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, getmedical help or contact a Poison Control Centerright 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 suppositorywith 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 movementChildren 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
Inactive Ingredients starch, shark liver oil, methylparaben, propylparaben
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