AYTUMUNE Fast Dissolving Tablets

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 tablet 
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 Fast Dissolving Tablets

ACTIVE INGREDIENT

Zincum Aceticum 2x
Zincum Gluconicum 1x

PURPOSE

Reduces duration and severity of the common cold

USES

• reduces duration of the common cold
• helps reduce severity of cold symptoms:
  • sore throat
  • stuffy nose
  • sneezing
  • coughing
  • nasal congestion

AytuMune is formulated to shorten the duration of the common cold and was not formulated to be effective for flu or allergies.

WARNINGS

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 are accompanied by a fever or new symptoms occur

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

Adults and children 12 years of age and older:
Note : For maximum benefit, begin treatment at first sign of cold.

• Completely dissolve entire tablet in mouth. Do not chew. Do not swallow whole.
• Take one tablet at the onset of symptoms.
• Repeat every three hours until symptoms are gone, up to 5 tablets per day.
• For best result, use for an additional 48 hours after symptoms subside.
• To avoid minor stomach upset, do not take on an empty stomach,
• 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 12 years of age: ask a doctor before use.

OTHER INFORMATION

store between 15°C-29°C (59°F-84°F)

INACTIVE INGREDIENTS

Ascorbic Acid, FD&C Yellow #6, Magnesium Stearate, Mannitol, Mono-Ammonium Glycyrrhizinate, Natural & Artificial Flavors, Povidone, Silicon Dioxide, Sodium Starch Glycolate, Sorbitol, Stearic Acid, Sucralose

AYTUMUNE 
zinc acetate anhydrous and zinc gluconate tablet

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 57483-890
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 25
ZINC GLUCONATE (UNII: U6WSN5SQ1Z) (ZINC CATION - UNII:13S1S8SF37)	ZINC GLUCONATE	1 [hp_X]  in 25

Inactive Ingredients
Ingredient Name	Strength
ASCORBIC ACID (UNII: PQ6CK8PD0R)
FD&C YELLOW NO. 6 (UNII: H77VEI93A8)
MAGNESIUM STEARATE (UNII: 70097M6I30)
MANNITOL (UNII: 3OWL53L36A)
AMMONIUM GLYCYRRHIZATE (UNII: 3VRD35U26C)
POVIDONE (UNII: FZ989GH94E)
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
SODIUM STARCH GLYCOLATE TYPE B (UNII: SP4S77AHO6)
SORBITOL (UNII: 506T60A25R)
STEARIC ACID (UNII: 4ELV7Z65AP)
SUCRALOSE (UNII: 96K6UQ3ZD4)

Product Characteristics
Color	orange	Score	no score
Shape	ROUND	Size	18mm
Flavor	CITRUS	Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 57483-890-01	1 in 1 CARTON	01/27/2021	12/31/2022
1		25 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		01/27/2021	12/31/2022

Labeler - Innovus Pharmaceuticals, Inc. (962507187)

Establishment
Name	Address	ID/FEI	Business Operations
Dynamic Pharmaceuticals, Inc		617660712	manufacture(57483-890)

Revised: 1/2023

Document Id: 986340b5-25c0-48e6-a093-d7319bd2626e

34390-5

Set id: a2c6f99c-b7d7-4f84-b2ef-523eef7dc120

Version: 2

Effective Time: 20230113