FDA Label for Rectibiom Hemorrhoid Relief

View Indications, Usage & Precautions

Rectibiom Hemorrhoid Relief Product Label

The following document was submitted to the FDA by the labeler of this product Biom Pharmaceutical Corporation. 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




Phenylephrine HCI, 0.25%

Hard Fat, 88.44%


Purpose



protectant

vasoconstrictor

protectant


Uses



  • Helps relieve the local itching and discomfort associated with hemorrhoids
  • Temporarily relieves burning and shrinks hemorrhoidal tissue.
  • Temporarily provide a coating for relief of anorectal discomforts.
  • Temporarily protects the inflammed, 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
  • 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


Storage



Store  at 20-250C(68-770C)


Inactive Ingredients



Silica gel, Hyaluronic acid, olive oil, Shea Butter, sesame seed oil, Probiotics(Lactobacillus reuteri, Lactobacillus Rhamnosus)


Otc - Questions



Call Weekdays 9 AM to 5PM est at +1941-552-8417


Box Information - 15 Count




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