AYTUMUNE Oral Spray

Manufacturer
Innovus Pharmaceuticals, Inc. | Dynamic Pharmaceuticals, Inc
Effective date
2021-01-24
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
legacy-cache
Hydrated at
2026-08-01 22:55:12

Label at a glance#

ProductAytuMune
Active ingredientZINC ACETATE, ZINC GLUCONATE
Label structure13 sections

Indications and 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.

Dosage and administration

• 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 av...

Label contents#

Full prescribing information#

ACTIVE INGREDIENT

OTC - ACTIVE INGREDIENT SECTION

Zincum Aceticum 2x
Zincum Gluconicum 1x

PURPOSE

OTC - PURPOSE SECTION

Reduces duration of a common cold

USES

INDICATIONS & USAGE SECTION

  • 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

WARNINGS SECTION

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

When using this product

OTC - WHEN USING SECTION

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

OTC - ASK DOCTOR SECTION

 a sensitivity to zinc or are allergic to zinc

Stop use and ask a doctor if

OTC - STOP USE SECTION

symptoms persist or if accompanied by fever.

If pregnant or breastfeeding

OTC - PREGNANCY OR BREAST FEEDING SECTION

ask a health professional before use.

Keep out of reach of children

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

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

DIRECTIONS

DOSAGE & ADMINISTRATION SECTION

• 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

OTHER SAFETY INFORMATION

store between 15°C-29°C (59°F-84°F)

Inactive Ingredeints

INACTIVE INGREDIENT SECTION

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

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

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NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
57483-09057483-090-43

Ingredients#

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Source Document#

Source XML

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Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
af7a7157-6209-4764-8971-d22ed8d3c21e1039d9cd-642f-4ea1-b662-fabdad0645822023-01-13WarningsExact identifier
spl set id: 1039d9cd-642f-4ea1-b662-fabdad064582

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.