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  5. Label Information: Hemorrhoidal

FDA Label for Hemorrhoidal

View Indications, Usage & Precautions

Table of Contents

    1. DRUG FACTS ACTIVE INGREDIENTS
    2. PURPOSES
    3. KEEP OUT OF REACH OF CHILDREN.
    4. USES
    5. WARNINGS
    6. ASK A DOCTOR OR PHARMACIST BEFORE USE IF YOU ARE
    7. ASK A DOCTOR BEFORE USE IF YOU HAVE
    8. WHEN USING THIS PRODUCT
    9. IF PREGNANT OR BREAST-FEEDING
    10. DIRECTIONS ADULTS
    11. OTHER INFORMATION
    12. INACTIVE INGREDIENTS
    13. HEMORRHOIDAL SUPPOSITORIES PRODUCT LABEL

Hemorrhoidal Product Label

The following document was submitted to the FDA by the labeler of this product Chain Drug Marketing Association, Inc.. 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.

Drug Facts Active Ingredients



Active Ingredients
(per suppository)

Cocoa butter 88.44 %
Phenylephrine hydrochloride 0.25 %


Purposes



Protectant
Vasoconstructor


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.


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.


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 Product Label




NDC 63868-208-12

QC QUALITY CHOICE


*Compare to the active ingredient in PREPARATION H®

HEMORRHOIDAL SUPPOSITORIES
Reduces Internal Swelling l Soothes and Protects

Cocoa Butter 88.4% l Phenylephrine Hydrochloride 0.25%
Prompt Soothing Relief From Painful Burning, Itching, and Discomfort
Provides Additional Nighttime Relief

12 ADULT SUPPOSITORIES

SATISFACTION GUARANTEED QC 100%

Distributed by C.D.M.A. Inc.©
43157 W. Nine Mile
Novi, MI 48376-0995
www.qualitychoice.com
Questions: 248-449-9300

Easy Open

*This product is not manufactured or distributed by Pfizer Consumer Healthcare., distributor of Preparation H®.


* Please review the disclaimer below.