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  5. Label Information: Signature Care Hemorrhoidal

FDA Label for Signature Care Hemorrhoidal

View Indications, Usage & Precautions

Table of Contents

    1. ACTIVE INGREDIENTS (IN EACH SUPPOSITORY)
    2. PURPOSES
    3. USES
    4. WARNINGS
    5. ASK A DOCTOR BEFORE USE IF YOU HAVE
    6. ASK A DOCTOR OR PHARMACIST BEFORE USE IF YOU ARE
    7. WHEN USING THIS PRODUCT
    8. STOP USE AND ASK A DOCTOR IF
    9. IF PREGNANT OR BREAST FEEDING,
    10. KEEP OUT OF REACH OF CHILDREN.
    11. DIRECTIONS
    12. OTHER INFORMATION
    13. INACTIVE INGREDIENTS
    14. QUESTIONS OR COMMENTS?
    15. PACKAGE/LABEL PRINCIPAL DISPLAY PANEL

Signature Care Hemorrhoidal Product Label

The following document was submitted to the FDA by the labeler of this product Safeway. 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)



Cocoa butter 88.44%

Phenylephrine HCl 0.25%


Purposes



Protectant

Vasoconstrictor


Uses



  • •helps relieve the local itching and discomfort associated with hemorrhoids
  • •temporarily relieves burning and shrinks hemorrhoidal tissue
  • •temporarily provides a coating for relief of anorectal discomforts
  • •temporarily protects the inflamed, irritated anorectal surface to help make bowel movements less painful

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.


When Using This Product



do not exceed the recommended daily dosage unless directed by a doctor


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 right away. (1-800-222-1222)


Directions



  • •adults: 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 this product.
  • •detach one suppository from the strip; remove the foil wrapper before inserting into the rectum as follows:
  • •hold suppository with rounded end up
  • •see illustrations: carefully separate foil tabs by inserting tip of fingernail at end marked “peel down”
  • •slowly and evenly peel apart (do not tear) foil by pulling tabs down both sides, to expose the suppository
  • •remove exposed suppository from wrapper
  • •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: ask a doctor

Other Information



  • •store at 20-25°C (68-77°F)

Inactive Ingredients



methylparaben, propylparaben, topical starch


Questions Or Comments?



1-888-723-3929


Package/Label Principal Display Panel



Hemorrhoidal Suppositories

COCOA BUTTER, PHENYLEPHRINE HCl

Prompt soothing relief from painful burning, itching and discomfort

Helps shrink swelling of irritated hemorrhoidal tissues

Protects irritated tissue

Also for nighttime relief

COMPARE TO Preparation H® Hemorrhoidal Suppositories active ingredients

12 SUPPOSITORIES


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