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  5. Label Information: Phenylephrine Hydrochloride

FDA Label for Phenylephrine Hydrochloride

View Indications, Usage & Precautions

Table of Contents

    1. ACTIVE INGREDIENTS
    2. PURPOSE
    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 BREASTFEEDING
    10. KEEP OUT OF REACH OF CHILDREN
    11. DIRECTIONS
    12. OTHER
    13. STORAGE
    14. INACTIVE INGREDIENTS
    15. OTC - QUESTIONS
    16. BOX INFORMATION - 12 COUNT
    17. BOX INFORMATION - 24 COUNT

Phenylephrine Hydrochloride Product Label

The following document was submitted to the FDA by the labeler of this product Walgreen Company. 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



Cocoa butter, 85.5%

Phenylephrine HCI, 0.25%

Shark liver oil, 3.0%


Purpose



protectant

vasoconstrictor

protectant


Uses



  • Temporarily shrinks hemorrhoidal tissue
  • Temporarily relieves itching burning and discomfort associated with hemorrhoids

Warnings



For rectal use only.



Ask A Doctor Before Use If You Have



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

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.


Stop Use And Ask A Doctor If



  • you experience bleeding
  • condition worsens or does not improve within 7 days.
    • These may be signs of a serious condition.

If Pregnant Or Breastfeeding



 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:
  • When practical, cleanse the affected area by patting or blotting with an appropriate cleansing tissue. Gently dry by patting or blotting with toilet tissue or soft cloth before insertion of this product.
  • Detach one suppository from strip
  • Remove wrapper before inserting into rectum
  • Hold suppository with rounded end up and insert tip of fingernail at end marked "peel down"
  • Carefully peel film slowly and evenly down both sides to expose suppository
  • Insert one suppository into rectum up to 4 times daily especially at night and morning or after each bowel movement
    • Children under 12 years:  ask a doctor

Other





Storage



Store in a cool place or at room temperature but not over 86° F.

Inactive Ingredients



Methylparaben, propylparaben, starch

Otc - Questions





Box Information - 12 Count



Walgreens

NDC 0363-0394-53

Hemorrhoidal
Suppositories

  • Temporary relief of burning, itching and discomfort
  • Shrinks swelling of irritated hemorrhoidal tissue
  • Protects irritated tissue
  • Also provides nighttime relief
    • Compare to Preparation H Suppositories® active ingredients*

    12 SUPPOSITORIES

    FOR YOUR SAFETY, SUPPOSITORIES ARE PACKAGED IN TAMPER-EVIDENT SEALED PLASTIC WRAPPER. DO NOT USE IF PLASTIC WRAPPER IS TORN OR OPEN.

    *This product is not manufactured or distributed by Wyeth Consumer Healthcare, Inc., owner of the registered trademark Preparation H®.

    Distributed by Walgreens Company, Deerfield, IL 60015-4616
    100% Satisfaction Guaranteed    www.walgreens.com
    12 count box - 33 14812WAL A

    12 count box - 33 14812WAL A





Box Information - 24 Count



Walgreens

NDC 0363-0394-62

Hemorrhoidal
Suppositories

  • Temporary relief of burning, itching and discomfort
  • Shrinks swelling of irritated hemorrhoidal tissue
  • Protects irritated tissue
  • Also provides nighttime relief


    • Compare to Preparation H Suppositories® active ingredients*

    24 SUPPOSITORIES

    FOR YOUR SAFETY, SUPPOSITORIES ARE PACKAGED IN TAMPER-EVIDENT SEALED PLASTIC WRAPPER. DO NOT USE IF PLASTIC WRAPPER IS TORN OR OPEN.

    *This product is not manufactured or distributed by Wyeth Consumer Healthcare, Inc., owner of the registered trademark Preparation H®.

    Distributed by Walgreens Company, Deerfield, IL 60015-4616
    100% Satisfaction Guaranteed    www.walgreens.com


    24 count box - 33 14824WAL A

    24 count box - 33 14824WAL A




* Please review the disclaimer below.