BLISS GVS HEMORRHOIDAL- hard fat, phenylephrine hcl suppository

United States - English - NLM (National Library of Medicine)

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Active ingredient:
HARD FAT (UNII: 8334LX7S21) (HARD FAT - UNII:8334LX7S21), PHENYLEPHRINE HYDROCHLORIDE (UNII: 04JA59TNSJ) (PHENYLEPHRINE - UNII:1WS297W6MV)
Available from:
Bliss GVS Pharma Limited
Administration route:
RECTAL
Prescription type:
OTC DRUG
Therapeutic indications:
Purposes Protectant Vasoconstrictor Uses - temporarily shrinks hemorrhoidal tissue - temporarily relieves the itching, burning and discomfort associated with hemorrhoids
Authorization status:
OTC monograph final
Authorization number:
72701-110-12, 72701-110-24

BLISS GVS HEMORRHOIDAL- hard fat, phenylephrine hcl suppository

Bliss GVS Pharma Limited

Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they

comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

----------

BLISS HEMORRHOIDAL SUPPOSITORIES

Drug Facts

Active ingredients (in each suppository)

Hard Fat 99.75%

Phenylephrine HCl 0.25%

Purposes

Protectant

Vasoconstrictor

Uses

temporarily shrinks hemorrhoidal tissue

temporarily relieves the itching, burning and discomfort associated with hemorrhoids

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.

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

Other information

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

Inactive ingredients

no additional inactive ingredient used

Questions or Comments? Call 1-888-830-6075

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

HEMORRHOIDAL SUPPOSITORIES

NDC 72701-110-12

RELIEVES HEMORRHOIDAL PAIN AND BURNING

Bliss GVS

12 Suppositories

BLISS GVS HEMORRHOIDAL

hard fat, phenylephrine hcl suppository

Product Information

Product T ype

HUMAN OTC DRUG

Ite m Code (Source )

NDC:7270 1-110

Route of Administration

RECTAL

Active Ingredient/Active Moiety

Ingredient Name

Basis of Strength

Stre ng th

HARD FAT (UNII: 8 334LX7S21) (HARD FAT - UNII:8 334LX7S21)

HARD FAT

249 3.75 mg

PHENYLEPHRINE HYDRO CHLO RIDE (UNII: 0 4JA59 TNSJ) (PHENYLEPHRINE -

UNII:1WS29 7W6 MV)

PHENYLEPHRINE

HYDROCHLORIDE

6 .25 mg

Bliss GVS Pharma Limited

Product Characteristics

Color

S core

S hap e

BULLET

S iz e

Flavor

Imprint Code

Contains

Packag ing

#

Item Code

Package Description

Marketing Start Date

Marketing End Date

1

NDC:7270 1-110 -12

2 in 1 CARTON

12/31/20 19

1

6 in 1 BLISTER PACK; Type 0 : No t a Co mbinatio n Pro duct

2

NDC:7270 1-110 -24

4 in 1 CARTON

12/31/20 19

2

6 in 1 BLISTER PACK; Type 0 : No t a Co mbinatio n Pro duct

Marketing Information

Marke ting Cate gory

Application Numbe r or Monograph Citation

Marke ting Start Date

Marke ting End Date

OTC mo no graph final

pa rt346

12/31/20 19

Labeler -

Bliss GVS Pharma Limited (675629890)

Establishment

Name

Ad d re s s

ID/FEI

Busine ss Ope rations

Bliss GVS Pharma Limited

6 756 30 49 3

ma nufa c ture (7270 1-110 )

Revised: 9/2019

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