AYTUMUNE Fast Dissolving Tablets

Manufacturer
Innovus Pharmaceuticals, Inc. | Dynamic Pharmaceuticals, Inc
Effective date
2021-01-27
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
legacy-cache
Hydrated at
2026-08-01 22:54:38

Label at a glance#

ProductAytuMune
Active ingredientZINC ACETATE, ZINC GLUCONATE
Label structure11 sections

Indications and 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.

Dosage and administration

• 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 ...

Label contents#

Full prescribing information#

ACTIVE INGREDIENT

OTC - ACTIVE INGREDIENT SECTION

Zincum Aceticum 2x
Zincum Gluconicum 1x

PURPOSE

OTC - PURPOSE SECTION

Reduces duration and severity of the common cold

USES

INDICATIONS & USAGE SECTION

  • 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.

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 are accompanied by a fever or new symptoms occur

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

• 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

OTHER SAFETY INFORMATION

store between 15°C-29°C (59°F-84°F)

INACTIVE INGREDIENTS

INACTIVE INGREDIENT SECTION

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

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

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NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
57483-89057483-890-01

Ingredients#

Every source-derived ingredient row is available through these pages.

DailyMed ingredient rows page 1 of 1 · 13 matching rows.

Source Document#

Source XML

openFDA label cross-check#

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Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
986340b5-25c0-48e6-a093-d7319bd2626ea2c6f99c-b7d7-4f84-b2ef-523eef7dc1202023-01-13WarningsExact identifier
spl set id: a2c6f99c-b7d7-4f84-b2ef-523eef7dc120

Reported adverse events (FAERS/openFDA)#

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