GAMMA -12  - interferon gamma-1b and human interleukin 12 solution/ drops 
Guna spa

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GAMMA-12

INTERFERON GAMMA    4C    IMMUNE SUPPORT
INTERLEUKIN 12    4C    IMMUNE SUPPORT

For the temporary relief of upper respiratory symptoms due to hay fever or airborne allergies such as: -Cough  –Airway irritation  –Shortness of breath

Stop use and ask doctor if symptoms of cough, shortness of breath, or wheezing do not improve, worsen or persist more than 3 days

If pregnant or breast-feeding ask a doctor before use

Keep this and all medicines out of reach of children

Take 15 minutes before meals
Adults and children 12 years and older    20 drops in a little water, 2 times per day
Children  between 12 years and 6 years of age    10 drops in a little water, 2 times per day
Children under 6 years     5 drops in a glass of water, 2 times per day

Questions?: info@gunainc.com
tel. (484) 223-3500

GAMMA -12  human interleukin 12 - interferon gamma-1b -   solution/ drops

Product Information Product Type HUMAN OTC DRUG NDC Product Code (Source) 17089-399 Route of Administration ORAL DEA Schedule

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength INTERFERON GAMMA-1B (INTERFERON GAMMA-1B) INTERFERON GAMMA-1B 4 [hp_C]  in 30 mL HUMAN INTERLEUKIN 12 (HUMAN INTERLEUKIN 12) HUMAN INTERLEUKIN 12 4 [hp_C]  in 30 mL

Inactive Ingredients Ingredient Name Strength ALCOHOL 9 mL  in 30 mL

Product Characteristics Color      Score      Shape Size Flavor Imprint Code Contains

Packaging # NDC Package Description Multilevel Packaging 1 17089-399-18 1 BOTTLE In 1 BOX contains a BOTTLE, DROPPER 1 30 mL In 1 BOTTLE, DROPPER This package is contained within the BOX (17089-399-18)

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
unapproved homeopathic		05/27/2010	05/28/2010

Labeler - Guna spa (430538264)

Establishment
Name	Address	ID/FEI	Operations
Guna spa		430538264	manufacture

Revised: 03/2010Guna spa