FDA.reportPublic FDA data

Bliss GVS Hemorrhoidal

Manufacturer
Bliss GVS Pharma Limited
Effective date
2024-12-19
Label type
HUMAN OTC DRUG LABEL
Version
5
Source
full-release
Hydrated at
2026-06-01 00:47:36

Label at a glance#

ProductBliss GVS Hemorrhoidal
Active ingredientHARD FAT, PHENYLEPHRINE HYDROCHLORIDE
Label structure10 sections

Indications and uses

temporarily shrinks hemorrhoidal tissue temporarily relieves the itching, burning and discomfort associated with hemorrhoids

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

Other information store below 30°C (86°F) to avoid melting.

Label contents#

Full prescribing information#

Active ingredients

OTC - ACTIVE INGREDIENT SECTION

(in each suppository)

Hard Fat 99.75%

Phenylephrine HCl 0.25%

Purposes

OTC - PURPOSE SECTION

Protectant

Vasoconstrictor

Uses

INDICATIONS & USAGE SECTION

  • temporarily shrinks hemorrhoidal tissue
  • temporarily relieves the itching, burning and discomfort associated with hemorrhoids

Warnings

WARNINGS SECTION

For rectal use only

OTC - ASK DOCTOR SECTION

Ask a doctor before use if you have

  • heart disease
  • thyroid disease
  • high blood pressure
  • diabetes
  • trouble urinating due to an enlarged prostate gland

OTC - ASK DOCTOR/PHARMACIST SECTION

Ask a doctor or pharmacist before use if you arepresently taking a prescription drug for high blood pressure or depression.

OTC - WHEN USING SECTION

When using this productdo not use more than directed

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 rectally up to 4 times daily

children under 12 years:ask a doctor

STORAGE AND HANDLING SECTION

Other information

store below 30°C (86°F) to avoid melting.

Inactive ingredients

INACTIVE INGREDIENT SECTION

none

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

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

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

HEMORRHOIDAL SUPPOSITORIES

NDC 72701-110-12

RELIEVES HEMORRHOIDAL PAIN AND BURNING

Bliss GVS

12 Suppositories

Hemorrhoidal Supp FinalHemorrhoidal Supp Final

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
2715398phenylephrine hydrochloride 0.25 % Rectal SuppositoryPSN5
2715398phenylephrine hydrochloride 0.0025 MG/MG Rectal SuppositorySCD5
2715398phenylephrine hydrochloride 0.25 % Rectal SuppositorySY5

DailyMed Pharmacologic Classes#

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

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
e4e263da-1c53-440f-bb80-b7a575843b5aProduct name120260313
d2168cac-a261-415a-9c78-3522859fa720Product name320251124
05a8cdd1-eeb8-409e-b938-0778225eca7dProduct name420250221
e5b5c132-b15d-435b-9faa-2f74e5cadcf9Product name820250220
f489e8f3-5c9e-4818-b539-a73587edcfc7Product name220240229
0f7ae452-206d-4fc4-868d-56fc47074084Product name120231011
b5abe2e3-39a1-43eb-9bff-f3c1653fe3dfProduct name220190930
e0b6c8be-f2bd-9f86-a9fc-3ed56ffaa814Product name320150910
42f3c020-f1b3-89bc-7bdc-e1f10e680485Product name120140508
e949165d-714d-e548-2b76-0cb5def16f30Product name120140508

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
72701-110-122023-04-12C16284748780-1f386c649-b12c-0266-e053-dadaa90a7c1aBLISS HEMORRHOIDAL SUPPOSITORIES
72701-110-242023-04-12C16284748780-1f386c649-b12c-0266-e053-dadaa90a7c1aBLISS HEMORRHOIDAL SUPPOSITORIES
72701-110-122023-01-30C16284748780-1f386c649-b12c-0266-e053-dadaa90a7c1aBLISS HEMORRHOIDAL SUPPOSITORIES
72701-110-242023-01-30C16284748780-1f386c649-b12c-0266-e053-dadaa90a7c1aBLISS HEMORRHOIDAL SUPPOSITORIES

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
72701-110-12Bliss GVS Hemorrhoidal6 in 1 BLISTER PACKSUPPOSITORY65
72701-110-12Bliss GVS Hemorrhoidal2 in 1 CARTONSUPPOSITORY25
72701-110-24Bliss GVS Hemorrhoidal6 in 1 BLISTER PACKSUPPOSITORY65
72701-110-24Bliss GVS Hemorrhoidal4 in 1 CARTONSUPPOSITORY45

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
72701-110BLISS GVS HEMORRHOIDAL (HARD FAT, PHENYLEPHRINE HCL) SUPPOSITORY [BLISS GVS PHARMA LIMITED]5Current NDC, Legacy NDC, 4 package rows20241222_88c49f6c-2a48-2dae-e053-2a95a90af20a.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
72701-11072701-110-12, 72701-110-24

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 FAT8334LX7S21ACTIB
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 HemorrhoidalHARD FAT, PHENYLEPHRINE HCLBliss GVS Pharma Limited88c49f6c-2a48-2dae-e053-2a95a90af20a2024-12-19WarningsExact identifier
ndc (package): 72701-110-24
ndc (package): 72701-110-12
ndc (product): 72701-110
ndc11 (package): 72701011024
ndc11 (package): 72701011012
spl id: 299d3539-d685-79e5-e063-6294a90a4043
spl set id: 88c49f6c-2a48-2dae-e053-2a95a90af20a

Reported adverse events (FAERS/openFDA)#

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