BLISS GVS HEMORRHOIDAL- phenylephrine hcl suppository

BLISS GVS HEMORRHOIDAL by

Drug Labeling and Warnings

BLISS GVS HEMORRHOIDAL by is a Otc medication manufactured, distributed, or labeled by Bliss GVS Pharma Limited. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Drug Facts

Active ingredient

(in each suppository)

Phenylephrine HCl 0.25%

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

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

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 unless directed by a doctor

Stop use and ask a doctor if

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

If pregnant or breast-feeding, 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

• 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

SPL UNCLASSIFIED SECTION

TAMPER EVIDENT: DO NOT USE IF SEALED WRAPPER AROUND

SUPPOSITORIES IS BROKEN OR MISSING

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

INGREDIENTS AND APPEARANCE

BLISS GVS HEMORRHOIDAL 
phenylephrine hcl suppository

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 72701-111
Route of Administration	RECTAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
PHENYLEPHRINE HYDROCHLORIDE (UNII: 04JA59TNSJ) (PHENYLEPHRINE - UNII:1WS297W6MV)	PHENYLEPHRINE HYDROCHLORIDE	6.25 mg

Inactive Ingredients
Ingredient Name	Strength
HARD FAT (UNII: 8334LX7S21)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 72701-111-12	2 in 1 CARTON	05/25/2023
1		6 in 1 BLISTER PACK; Type 0: Not a Combination Product
2	NDC: 72701-111-24	4 in 1 CARTON	05/25/2023
2		6 in 1 BLISTER PACK; Type 0: Not a Combination Product
3	NDC: 72701-111-48	8 in 1 CARTON	05/25/2023
3		6 in 1 BLISTER PACK; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	M015	05/25/2023

Labeler - Bliss GVS Pharma Limited (675629890)

Establishment
Name	Address	ID/FEI	Business Operations
Bliss GVS Pharma Limited		675630493	manufacture(72701-111)