Zicam Cold Remedy

Manufacturer
Matrixx Initiatives, Inc. | BestCo
Effective date
2022-02-03
Label type
HUMAN OTC DRUG LABEL
Version
3
Source
legacy-cache
Hydrated at
2026-08-01 22:09:52

Label at a glance#

ProductZicam Cold Remedy
Active ingredientZINC ACETATE ANHYDROUS, ZINC GLUCONATE
Label structure10 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: take 1 lozenge at the onset of symptoms. Completely dissolve lozenge in mouth. Do not chew. Do not swallow whole. repeat every 2 – 3 hours, not to exceed 7 lozenges in 24 hours. Take until symptoms are gone. to avoid minor stomach upset, do not take on an empty stom...

Storage and handling

store between 15-29°C (59-84°F) avoid freezing and excessive heat

Label contents#

Full prescribing information#

SPL UNCLASSIFIED SECTION

Drug Facts

Active ingredients (in each lozenge)

OTC - ACTIVE INGREDIENT SECTION

Zincum aceticum 2x

Zincum gluconicum 2x

Purposes

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

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.

Ask a doctor before use if you have

OTC - ASK DOCTOR SECTION

  • a sensitivity to zinc or are allergic to zinc

OTC - STOP USE SECTION

Stop use and ask a doctor if symptoms, including cough, persist, recur or are accompanied by a fever, rash, or persistent headache, or if new symptoms occur. A persistent cough that lasts for more than one week may be a sign of a serious condition.

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:
    • take 1 lozenge at the onset of symptoms. Completely dissolve lozenge in mouth. Do not chew. Do not swallow whole.
    • repeat every 2 – 3 hours, not to exceed 7 lozenges in 24 hours. Take 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)
  • avoid freezing and excessive heat

Inactive ingredients

INACTIVE INGREDIENT SECTION

citric acid, corn syrup, FD&C blue no. 1, FD&C red no. 40, malic acid, menthol, natural flavors, purified water, sucralose, sucrose

SPL UNCLASSIFIED SECTION

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

PRINCIPAL DISPLAY PANEL - 25 Lozenge Pouch Carton

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

NDC 62750-079-10

ZICAM®
COLD REMEDY

SHORTENS COLDS
+ SOOTHES SORE THROATS
AND COUGHS

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

CLINICALLY PROVEN
TO SHORTEN COLDS

LOZENGES

GREAT TASTING

Wild Cherry Flavor

HOMEOPATHIC
25
Individually Wrapped
LOZENGES

Principal Display Panel - 25 Lozenge Pouch Carton
Principal Display Panel - 25 Lozenge Pouch Carton

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
62750-079-102022-02-03C16284748780-1d6a99b39-d1be-a426-e053-dadaa90af4c2Zicam ® Cold Remedy Lozenges
62750-079-102022-01-28C16284748780-1d6a99b39-d1be-a426-e053-dadaa90af4c2Zicam ® Cold Remedy Lozenges

Products#

Every source-derived product name is available through these pages.

DailyMed product names page 1 of 1 · 14 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
62750-07962750-079-10

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 11 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
4ffc5d7b-7360-425b-ad61-5f6157789223ac7e37b9-182e-4297-a69c-eef3bdd3fc702022-02-03WarningsExact identifier
spl id: 4ffc5d7b-7360-425b-ad61-5f6157789223
spl set id: ac7e37b9-182e-4297-a69c-eef3bdd3fc70

Reported adverse events (FAERS/openFDA)#

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