BLISS GVS HEMORRHOIDAL- hard fat, 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]

SPL UNCLASSIFIED SECTION

Drug Facts

ACTIVE INGREDIENT

Active ingredients (in each suppository)

Hard Fat 99.75%

Phenylephrine HCl 0.25%

PURPOSE

Purposes

Protectant

Vasoconstrictor

INDICATIONS & USAGE

Uses

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

WARNINGS

Warnings

For rectal use only

Ask a doctor before use if you have

• heart disease
• thyroid disease
• high blood pressure
• diabetes
• trouble urinating due to an enlarged 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 use more than directed

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.

DOSAGE & ADMINISTRATION

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 rectally up to 4 times daily

children under 12 years: ask a doctor

STORAGE AND HANDLING

Other information

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

INACTIVE INGREDIENT

Inactive ingredients

no additional inactive ingredient used

QUESTIONS

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

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

PRINCIPAL DISPLAY PANEL

HEMORRHOIDAL SUPPOSITORIES

NDC: 72701-110-12

RELIEVES HEMORRHOIDAL PAIN AND BURNING

Bliss GVS

12 Suppositories

INGREDIENTS AND APPEARANCE

BLISS GVS HEMORRHOIDAL 
hard fat, phenylephrine hcl suppository

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 72701-110
Route of Administration	RECTAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
HARD FAT (UNII: 8334LX7S21) (HARD FAT - UNII:8334LX7S21)	HARD FAT	2493.75 mg
PHENYLEPHRINE HYDROCHLORIDE (UNII: 04JA59TNSJ) (PHENYLEPHRINE - UNII:1WS297W6MV)	PHENYLEPHRINE HYDROCHLORIDE	6.25 mg

Product Characteristics
Color		Score
Shape	BULLET	Size
Flavor		Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 72701-110-12	2 in 1 CARTON	12/31/2019
1		6 in 1 BLISTER PACK; Type 0: Not a Combination Product
2	NDC: 72701-110-24	4 in 1 CARTON	12/31/2019
2		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	part346	12/31/2019

Labeler - Bliss GVS Pharma Limited (675629890)

Establishment
Name	Address	ID/FEI	Business Operations
Bliss GVS Pharma Limited		675630493	manufacture(72701-110)