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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
    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. PACKAGE INFORMATION

Phenylephrine Hydrochloride Product Label

The following document was submitted to the FDA by the labeler of this product H And P Industries, Inc. Dba Triad Group. 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





Package Information




NDC 50730-4812-0

Live Better

Hemorrhoidal
Suppositories
PHENYLEPHRINE HCL 0.25%

  • Temporary relief of burning, itching and discomfort
  • Provides nighttime relief
  • Shrinks swelling of irritated hemorrhoidal tissue
  • Protects irritated tissue
  • Easy to open
    • 12 Suppositories

    DISTRIBUTED BY OMNIPOINT, INC.
    2 PARAGON DRIVE, MONTVALE, NJ 07654
    2009 ALL RIGHTS RESERVED

    Live Better products provide a simple way to look after yourself
    and your family. All of our products are crafted from high quality
    ingredients to exacting standards.
    Live Better is a great way to meet the health needs of your busy
    lifestyle. Live Better helps you be better.
    Live Better, for life.


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

    carton - 33 4812AP C B1208

    carton - 33 4812AP C B1208



* Please review the disclaimer below.