FDA Label for Hemorrhoidal
View Indications, Usage & Precautions
- ACTIVE INGREDIENTS (IN EACH SUPPOSITORY)
- PURPOSE
- USES
- WARNINGS
- ASK A DOCTOR BEFORE USE IF YOU HAVE
- ASK A DOCTOR OR PHARMACIST BEFORE USE IF YOU ARE
- WHEN USING THIS PRODUCT,
- STOP USE AND ASK A DOCTOR IF
- IF PREGNANT OR BREAST-FEEDING,
- KEEP OUT OF REACH OF CHILDREN.
- DIRECTIONS
- OTHER INFORMATION
- INACTIVE INGREDIENTS
- PACKAGE LABEL.PRINCIPAL DISPLAY PANEL
Hemorrhoidal Product Label
The following document was submitted to the FDA by the labeler of this product Major Pharmaceuticals. The document includes published materials associated whith this product with the essential scientific information about this product as well as other prescribing information. Product labels may durg indications and usage, generic names, contraindications, active ingredients, strength dosage, routes of administration, appearance, warnings, inactive ingredients, etc.
Active Ingredients (In Each Suppository)
Hard Fat 88.44%
Phenylephrine hydrochloride 0.25%
Purpose
Protectant
Vasoconstrictor
Uses
- temporarily shrinks hemorrhoidal tissue
- gives temporary relief to the itching, burning and discomfort associated with hemorrhoids
Warnings
For rectal use only
Ask A Doctor Before Use If You Have
- heart disease
- thyroid disease
- high blood pressure
- diabetes
- trouble urinating due to an enlargedprostate gland
Ask A Doctor Or Pharmacist Before Use If You Are
presently taking a prescription drug for high blood pressure or depression
When Using This Product,
do not use more than directed
Stop Use And Ask A Doctor If
- bleeding occurs
- condition worsens or does not improve within 7 days
If Pregnant Or Breast-Feeding,
ask a health professional before use.
Keep Out Of Reach Of Children.
If swallowed, get medical help or contact a Poison Control Center (1-800-222-1222) right away.
Directions
- when practical, cleanse the affected area by patting or blotting with an appropriate cleansing wipe.
- gently dry by patting or blotting with a tissue or a soft cloth before insertion of suppository.
- detach on suppository from the strip
- separate the two tabs of the white plastic wrap
- with thumb and forefinger of each hand, grasp the tabs and peel downward, unwrapping the suppository
- insert one suppository into the rectum
adults and children 12 years and over: insert one suppository rectally up to 4 times daily
children under 12 years: ask a doctor
Other Information
store below 30°C (86°F) to avoid melting.
Inactive Ingredients
corn starch, methylparaben, propylparaben
Package Label.Principal Display Panel
The product package shown above represents a sample of that currently in use. Additional packaging may also be available.
Major Hemorrhoidal Suppositories 12ct
Distributed by
Major Pharmaceuticals
17177 N. Laurel Park Drive
Suite 233
Livonia, MI 48152
MajorHemSupp.jpg
* Please review the disclaimer below.
