Zicam Cold Remedy Mist

Manufacturer
Matrixx Initiatives, Inc. | Accupac, Inc
Effective date
2019-10-22
Label type
HUMAN OTC DRUG LABEL
Version
2
Source
legacy-cache
Hydrated at
2026-08-02 00:06:33

Label at a glance#

ProductZicam Cold Remedy Mist
Active ingredientZINC ACETATE ANHYDROUS, 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 Zicam ® Cold Remedy was formulated to shorten the duration of the common cold and was not formulated to be effective for flu or allergies.

Dosage and administration

for best results, use at the first sign of a cold and continue to use until symptoms completely subside adults and children 12 years of age and older: spray 5 times in mouth at the onset of symptoms. Spray on inside of cheeks, roof of mouth and gums. Retain for 15 seconds. Swallow. repeat every 3 hours until symptoms are gone to avoid minor stomach upset, do not take on an empty stomach do not eat or drink for 15 ...

Storage and handling

store between 15-29°C (59-84°F)

Label contents#

Full prescribing information#

SPL UNCLASSIFIED SECTION

Drug Facts

Active ingredients

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

Zicam® Cold Remedy was formulated to shorten the duration of the common cold and was not formulated to be effective for flu or allergies.

Warnings

WARNINGS SECTION

SPL UNCLASSIFIED SECTION

For oral use only

Sore throat warning

SPL UNCLASSIFIED SECTION

If sore throat is severe, persists for more than 2 days, is accompanied or followed by fever, headache, rash, nausea, or vomiting, consult a doctor promptly.

Cough warning

SPL UNCLASSIFIED SECTION

A persistent cough may be a sign of a serious condition. If cough persists for more than 1 week, tends to recur, or is accompanied by fever, rash, or persistent headache, consult a doctor.

OTC - ASK DOCTOR SECTION

Ask a doctor before use if you have a sensitivity to zinc or are allergic to zinc

OTC - WHEN USING SECTION

When using this product avoid contact with eyes. Rinse right away with water if it gets in eyes and seek medical help right away.

OTC - STOP USE SECTION

Stop use and ask a doctor if symptoms persist or are accompanied by a fever or new symptoms occur

OTC - PREGNANCY OR BREAST FEEDING SECTION

If pregnant or breast-feeding, ask a health professional before use.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Keep out of reach of children. 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 until symptoms completely subside
  • adults and children 12 years of age and older:
    • spray 5 times in mouth at the onset of symptoms. Spray on inside of cheeks, roof of mouth and gums. Retain for 15 seconds. Swallow.
    • repeat every 3 hours until symptoms are gone
    • 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

STORAGE AND HANDLING SECTION

  • store between 15-29°C (59-84°F)

Inactive ingredients

INACTIVE INGREDIENT SECTION

acesulfame potassium, artificial flavor, benzalkonium chloride, glycerin, malic acid, PEG-40 hydrogenated castor oil, purified water, sucralose

Questions? Comments? Side Effects?

OTC - QUESTIONS SECTION

call 877-942-2626 toll free
www.zicam.com

SPL UNCLASSIFIED SECTION

Distributed by Matrixx Initiatives, Inc.
Scottsdale, Arizona 85260.

PRINCIPAL DISPLAY PANEL - 30 mL Bottle Carton

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

NDC 62750-076-10

ZICAM®
COLD REMEDY

SHORTENS COLDS

+ SOOTHES SORE THROATS
AND COUGHS

TAKE AT THE FIRST
THE
PRE-COLD®
MEDICINE
SIGN OF A COLD

NEW!

SEE
WHAT'S
INSIDE!

#1 COLD SHORTENING BRAND*

ORAL MIST™

GREAT TASTING

Cherry Flavor

1.0 FL OZ
(30 mL)

HOMEOPATHIC

Principal Display Panel - 30 mL Bottle Carton
Principal Display Panel - 30 mL Bottle Carton

Products#

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NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
62750-07662750-076-10

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 9 matching rows.

Source Document#

Source XML

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
fb0cc8f8-1dd8-4967-87cd-47ba43f92f7dc4146eff-2d41-41aa-8156-2c8cf9b40d1e2019-10-22WarningsExact identifier
spl id: fb0cc8f8-1dd8-4967-87cd-47ba43f92f7d
spl set id: c4146eff-2d41-41aa-8156-2c8cf9b40d1e

Reported adverse events (FAERS/openFDA)#

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