AytuMune by Innovus Pharmaceuticals, Inc. / Dynamic Pharmaceuticals, Inc AYTUMUNE Oral Spray

AytuMune by

Drug Labeling and Warnings

AytuMune by is a Homeopathic medication manufactured, distributed, or labeled by Innovus Pharmaceuticals, Inc., Dynamic Pharmaceuticals, Inc. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

AYTUMUNE- zinc acetate anhydrous and zinc gluconate spray 
Innovus Pharmaceuticals, Inc.

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.

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AYTUMUNE Oral Spray

ACTIVE INGREDIENT

Zincum Aceticum 2x
Zincum Gluconicum 1x

PURPOSE

Reduces duration of a common cold

USES

• Reduces duration of a common cold
• Reduces duration of cold symptoms:
  • Sneezing
  • Sore Throat
  • Stuffy Nose
  • Coughing
  • Congestion

AytuMune Oral Spray is formulated to reduce the duration of a common cold and may not  be effective for flu or allergies.

WARNINGS

For oral use only, not for use in nasal pathways.

When using this product

avoid contact with the eyes. In case of accidental contact with eyes, flush with water and immediately seek professional help.

Ask a doctor before use if you have

 a sensitivity to zinc or are allergic to zinc

Stop use and ask a doctor if

symptoms persist or if accompanied by fever.

If pregnant or breastfeeding

ask a health professional before use.

Keep out of reach of children

In case of overdose, get medical help or contact a Poison Control Center right away.

DIRECTIONS

For best results, use at the first sign of a cold and continue to use for an additional 48 hours after symptoms subside.
Adults and children 12 years of age and older: 
o    Remove protective over-cap.
o    Spray 4-5 times into mouth at the onset of symptoms.
o    Spray on inside of cheeks, roof of mouth and gums. Retain for 15 seconds. Swallow.
o    Repeat every three hours until symptoms are gone.
o    To avoid minor stomach upset, do not take on an empty stomach.
o    Do not eat or drink for 15 minutes after use. Do not eat or drink citrus fruits or juices for 30 minutes before or after use. Otherwise, drink plenty of fluids.
Children under 3 years of age, consult a doctor before use.

OTHER INFORMATION

store between 15°C-29°C (59°F-84°F)

Inactive Ingredeints

Glycerin, Peppermint Flavor, Potassium Sorbate, Purified Water, Sucralose

AYTUMUNE 
zinc acetate anhydrous and zinc gluconate spray

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 57483-090
Route of Administration	ORAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
ZINC ACETATE (UNII: FM5526K07A) (ZINC CATION - UNII:13S1S8SF37)	ZINC CATION	2 [hp_X]  in 1 mL
ZINC GLUCONATE (UNII: U6WSN5SQ1Z) (ZINC CATION - UNII:13S1S8SF37)	ZINC GLUCONATE	1 [hp_X]  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
GLYCERIN (UNII: PDC6A3C0OX)
POTASSIUM SORBATE (UNII: 1VPU26JZZ4)
WATER (UNII: 059QF0KO0R)
SUCRALOSE (UNII: 96K6UQ3ZD4)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 57483-090-43	1 in 1 CARTON	01/24/2021	12/31/2022
1		30 mL in 1 BOTTLE; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
unapproved homeopathic		01/24/2021	12/31/2022

Labeler - Innovus Pharmaceuticals, Inc. (962507187)

Establishment
Name	Address	ID/FEI	Business Operations
Dynamic Pharmaceuticals, Inc		617660712	manufacture(57483-090)

Revised: 1/2023

Document Id: af7a7157-6209-4764-8971-d22ed8d3c21e

34390-5

Set id: 1039d9cd-642f-4ea1-b662-fabdad064582

Version: 2

Effective Time: 20230113