Active Ingredient
(in each suppository)
Phenylephrine HCl 0.25%
Bliss Gvs Hemorrhoidal Suppository
FDA Label NDC 72701-111
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Bliss Gvs Pharma Limited for the product Bliss Gvs Hemorrhoidal (NDC 72701-111). This document serves as the official prescribing information, containing essential scientific data and clinical materials required for healthcare providers and patients.
This specific version of the label includes detailed information regarding active ingredient, purpose, uses, warnings, otc - ask doctor, otc - ask doctor/pharmacist, otc - when using, otc - stop use, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Purpose
Vasoconstrictor
Uses
- helps relieve the local itching and discomfort associated with hemorrhoids
- temporarily shrinks hemorrhoidal tissue
- temporarily reduces the swelling associated with irritation in hemorrhoids and other anorectal disorders
Warnings
For rectal use only
Otc - Ask Doctor
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
Otc - Ask Doctor/Pharmacist
Ask a doctor or pharmacist before use if you are
presently taking a prescription drug for high blood pressure or depression
Otc - When Using
When using this product do not exceed the recommended daily dosage unless directed by a doctor
Otc - Stop Use
Stop use and ask a doctor if
- bleeding occurs
- condition worsens or does not improve within 7 days
Otc - Pregnancy Or Breast Feeding
If pregnant or breast-feeding, ask a health professional before use
Otc - 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.
Directions
- 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 suppository.
- detach one suppository from the strip
- separate the two tabs of the white plastic wrap
- with thumb and forefinger of each hand, grasp the tabs and peel downward, unwrapping the suppository
- insert one suppository into the rectum
adults and children 12 years and over: 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 Ingredient
Hard Fat
Questions Or Comments?
Call 1-888-830-6075
Other
TAMPER EVIDENT: DO NOT USE IF SEALED WRAPPER AROUND
SUPPOSITORIES IS BROKEN OR MISSING
Package Label.Principal Display Panel
HEMORRHOIDAL SUPPOSITORIES
NDC 72701-111-12
Prevents Further Irritation
Reduces Internal Hemorrhoidal Swelling
Prompt Relief from Itching and Discomfort
Also for Nighttime Relief
Bliss GVS
12 Suppositories
Manufactured and Marketed by:
BLISS GVS PHARMA LTD.
102, Hyde Park, Saki Vihar Road, Andheri (E),
Mumbai-400 072, INDIA
Email: [email protected] • www.blissgvs.com
Label (72701 111)
* Please review the disclaimer below.
