FDA.reportPublic FDA data

BLISS GVS HEMORRHOIDAL

Manufacturer
Bliss GVS Pharma Limited
Effective date
2024-12-21
Label type
HUMAN OTC DRUG LABEL
Version
3
Source
full-release
Hydrated at
2026-06-01 00:48:10

Label at a glance#

ProductBLISS GVS HEMORRHOIDAL
Active ingredientPHENYLEPHRINE HYDROCHLORIDE
Label structure10 sections

Indications and 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

Dosage and administration

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 ...

Storage and handling

store at 20-25°C (68-77°F)

Label contents#

Full prescribing information#

Active ingredient

OTC - ACTIVE INGREDIENT SECTION

(in each suppository)

Phenylephrine HCl 0.25%

Purpose

OTC - PURPOSE SECTION

Vasoconstrictor

Uses

INDICATIONS & USAGE SECTION

  • 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

WARNINGS SECTION

For rectal use only

OTC - ASK DOCTOR SECTION

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 SECTION

Ask a doctor or pharmacist before use if you are

presently taking a prescription drug for high blood pressure or depression

OTC - WHEN USING SECTION

When using this product do not exceed the recommended daily dosage unless directed by a doctor

OTC - STOP USE SECTION

Stop use and ask a doctor if

  • bleeding occurs
  • condition worsens or does not improve within 7 days

OTC - PREGNANCY OR BREAST FEEDING SECTION

If pregnant or breast-feeding, ask a health professional before use

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

Directions

DOSAGE & ADMINISTRATION SECTION

  • 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

STORAGE AND HANDLING SECTION

store at 20-25°C (68-77°F)

Inactive ingredient

INACTIVE INGREDIENT SECTION

Hard Fat

Questions or Comments?

OTC - QUESTIONS SECTION

Call 1-888-830-6075

SPL UNCLASSIFIED SECTION

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: info@blissgvs.com • www.blissgvs.com

labellabel

DailyMed Pharmacologic Classes#

Class, Version, Type table
ClassVersionTypeEffective
PHENYLEPHRINE Pharmacologic Class Indexing2Indexing - Pharmacologic Class20180813

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
72701-111-12BLISS GVS HEMORRHOIDAL6 in 1 BLISTER PACKSUPPOSITORY63
72701-111-12BLISS GVS HEMORRHOIDAL2 in 1 CARTONSUPPOSITORY23
72701-111-24BLISS GVS HEMORRHOIDAL4 in 1 CARTONSUPPOSITORY43
72701-111-24BLISS GVS HEMORRHOIDAL6 in 1 BLISTER PACKSUPPOSITORY63
72701-111-48BLISS GVS HEMORRHOIDAL6 in 1 BLISTER PACKSUPPOSITORY63
72701-111-48BLISS GVS HEMORRHOIDAL8 in 1 CARTONSUPPOSITORY83

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
72701-111BLISS GVS HEMORRHOIDAL (PHENYLEPHRINE HCL) SUPPOSITORY [BLISS GVS PHARMA LIMITED]3Current NDC, 6 package rows20241222_fceea303-2ea0-10e9-e053-6294a90a5492.zip

Products#

Every source-derived product name is available through these pages.

DailyMed product names page 1 of 1 · 5 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
72701-11172701-111-12, 72701-111-24, 72701-111-48

Ingredients#

Every source-derived ingredient row is available through these pages.

DailyMed ingredient rows page 1 of 1 · 2 matching rows.

Name, UNII, Kind table
NameUNIIKind
HARD FAT8334LX7S21IACT
PHENYLEPHRINE HYDROCHLORIDE04JA59TNSJACTIB

Source Document#

Source XML

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
BLISS GVS HEMORRHOIDALPHENYLEPHRINE HCLBliss GVS Pharma Limitedfceea303-2ea0-10e9-e053-6294a90a54922024-12-21WarningsExact identifier
ndc (package): 72701-111-12
ndc (package): 72701-111-24
ndc (package): 72701-111-48
ndc (product): 72701-111
ndc11 (package): 72701011112
ndc11 (package): 72701011124
ndc11 (package): 72701011148
spl id: 29c2797d-6f07-7c31-e063-6394a90a19b5
spl set id: fceea303-2ea0-10e9-e053-6294a90a5492

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.