FDA Label for Hemorrhoidal

View Indications, Usage & Precautions

ACTIVE INGREDIENTS (PER SUPPOSITORY)
PURPOSE
USES
WARNINGS
ASK A DOCTOR OR PHARMACIST BEFORE USE IF YOU ARE
ASK A DOCTOR BEFORE USE IF YOU HAVE
WHEN USING THIS PRODUCT
IF PREGNANT OR BREAST-FEEDING
KEEP OUT OF REACH OF CHILDREN
DIRECTIONS ADULTS
OTHER INFORMATION
INACTIVE INGREDIENTS
HEMORRHOIDAL SUPPOSITORIES LABEL

Hemorrhoidal Product Label

The following document was submitted to the FDA by the labeler of this product Graxcell Pharmaceutical, Llc. 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 (Per Suppository)

Cocoa butter 88.44 %

Phenylephrine hydrochloride 0.25 %

Purpose

Protectant

Vasoconstructor

Uses

temporarily shrinks hemorrhoidal tissues
gives temporary relief to the itching, burning and discomfort associated with hemorrhoids
aids in protecting irritated anorectal areas

Warnings

For rectal use only

Ask A Doctor Or Pharmacist Before Use If You Are

presently taking a prescription drug for high blood pressure or depression

Ask A Doctor Before Use If You Have

heart disease
thyroid disease
high blood pressure
diabetes
difficulty in urination due to enlargement of the prostate gland

When Using This Product

do not exceed the recommended daily dosage unless directed by a doctor
in case of bleeding or if condition worsens or does not improve within 7 days, consult a doctor promptly

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 right away.

Directions Adults

detach one suppository from the strip. Remove the wrapper before inserting into the rectum.
insert one suppository into the rectum up to 4 times daily, especially at night, in the morning or after each bowel movement. Children under 12 years of age: consult doctor

Other Information

Store at room temperature or in a cool place but not over 80° F

Inactive Ingredients

methylparaben, propylparaben, starch

Hemorrhoidal Suppositories Label

GRAXCELL PHARMACEUTICAL, LLC.

NDC 70795-1021-2

*Compare to active ingredients in PREPARATION H

Hemorrhoidal Suppositories

HELPS REDUCE INFLAMMATION AND SWELLING OF HAEMORRHOIDAL TISSUES PROVIDES TEMPORARY RELIEF IN MANY CASES

12 SUPPOSITORIES

Label 1 - 2