GUNA-INF GAMMA- interferon gamma-1b solution/ drops

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

INTERFERON GAMMA-1B (UNII: 21K6M2I7AG) (INTERFERON GAMMA-1B - UNII:21K6M2I7AG)

Available from:

Guna spa

Administration route:

ORAL

Prescription type:

OTC DRUG

Therapeutic indications:

INTERFERON GAMMA-1B   4C   CHRONIC VIRAL INFECTIONS CHRONIC VIRAL INFECTIONS Take 15 minutes before meals.

Authorization status:

unapproved homeopathic

Summary of Product characteristics

GUNA-INF GAMMA- INTERFERON GAMMA-1B SOLUTION/ DROPS
GUNA SPA
_Disclaimer: This homeopathic product has not been evaluated by the
Food and Drug_
_Administration for safety or efficacy. FDA is not aware of scientific
evidence to support_
_homeopathy as effective._
----------
GUNA-INF GAMMA
ACTIVE INGREDIENTS/PURPOSE
INTERFERON GAMMA-1B 4C CHRONIC VIRAL INFECTIONS
USES
CHRONIC VIRAL INFECTIONS
WARNINGS
STOP USE AND ASK DOCTOR if symptoms worsen or persist more than 5 days
PREGNANCY
IF PREGNANT OR BREAST-FEEDING ask a doctor before use
WARNINGS
KEEP THIS AND ALL MEDICINES out of reach of children
DIRECTIONS
Take 15 minutes before meals.
ADULTS AND CHILDREN 12 YEARS AND OLDER 20 drops twice a day in a
little water. Hold in
the mouth for about 30 seconds then swallow.
CHILDREN BETWEEN 12 YEARS AND 6 YEARS OF AGE 10 drops twice a day in a
little
water. Hold in the mouth for about 30 seconds then swallow.
CHILDREN UNDER 6 YEARS 5 drops twice a day in a glass of water.
QUESTIONS
QUESTIONS?: [e-mail]
Tel. [phone]
INACTIVE INGREDIENT: ETHYL ALCOHOL 30%.
Take 15 minutes before meals.
PRINCIPAL DISPLAY PANEL
Guna spa
GUNA-INF GAMMA
interferon gamma-1b solution/ drops
PRODUCT INFORMATION
PRODUCT TYPE
HUMAN OTC DRUG
ITEM CODE (SOURCE)
NDC:17089-378
ROUTE OF ADMINISTRATION
ORAL
ACTIVE INGREDIENT/ACTIVE MOIETY
INGREDIENT NAME
BASIS OF
STRENGTH
STRENGTH
INTERFERON GAMMA-1B (UNII: 21K6M2I7AG) (INTERFERON GAMMA-1B -
UNII:21K6M2I7AG)
INTERFERON
GAMMA-1B
4 [hp_C]
in 30 mL
INACTIVE INGREDIENTS
INGREDIENT NAME
STRENGTH
ALCOHOL (UNII: 3K9958V90M)
9 mL in 30 mL
PACKAGING
# ITEM CODE
PACKAGE DESCRIPTION
MARKETING START
DATE
MARKETING END
DATE
1
NDC:17089-
378-18
1 in 1 BOX
06/17/2008
1
30 mL in 1 BOTTLE, DROPPER; Type 0: Not a
Combination Product
MARKETING INFORMATION
MARKETING
CATEGORY
APPLICATION NUMBER OR MONOGRAPH
CITATION
MARKETING START
DATE
MARKETING END
DATE
unapproved
homeopathic
06/17/2008
LABELER -
Guna spa (430538264)
ESTABLISHMENT
NAME
ADDRESS
ID/FEI
BUSINESS OPERATIONS
Guna spa
338587646
manufacture(17089-378)