Zicam

Manufacturer
Matrixx Initiatives, Inc. | LNK International, Inc.
Effective date
2023-01-26
Label type
HUMAN OTC DRUG LABEL
Version
8
Source
full-release
Hydrated at
2026-06-01 02:19:59

Label at a glance#

ProductZicam Cold Remedy Rapidmelts Citrus
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: take 1 tablet at the onset of symptoms dissolve entire tablet in mouth. Do not chew. Do not swallow whole. repeat every 2–3 hours, not to exceed 7 tablets in 24 hours. Take until symptoms are gone. to avoid minor stomach upset, do not take on an empty stomach do not...

Storage and handling

store between 15-29°C (59-84°F)

Label contents#

Full prescribing information#

SPL UNCLASSIFIED SECTION

Drug Facts

Active ingredients (in each tablet)

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

OTC - ASK DOCTOR SECTION

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

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:
    • take 1 tablet at the onset of symptoms
    • dissolve entire tablet in mouth. Do not chew. Do not swallow whole.
    • repeat every 2–3 hours, not to exceed 7 tablets 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)

Inactive ingredients

INACTIVE INGREDIENT SECTION

ascorbic acid, crospovidone, FD&C yellow no. 6 aluminum lake, magnesium stearate, mannitol, mono-ammonium glycyrrhizinate, natural and artificial flavor, sodium starch glycolate, stearic acid, sucralose

Questions? Comments? Side Effects?

OTC - QUESTIONS SECTION

call 877-942-2626 toll free

SPL UNCLASSIFIED SECTION

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

PRINCIPAL DISPLAY PANEL - 25 Tablet Bottle Carton

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

CLINICALLY PROVEN TO SHORTEN COLDS

GREAT
TASTING!

RAPIDMELTS®

Citrus Flavor

25
Quick Dissolve
TABLETS

HOMEOPATHIC

PRINCIPAL DISPLAY PANEL - 25 Tablet Bottle Carton
PRINCIPAL DISPLAY PANEL - 25 Tablet Bottle Carton

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
f47a510b-6679-4664-b2d6-47b5c4afe7ccProduct name420260217
030ce964-9b2d-45aa-b5d3-f78ce03ef61cProduct name220250515
0306390c-dd77-4363-afe0-63c58088b2a1Product name120220120
503ea967-4b9c-48cf-9e87-c7975295849dProduct name220220120
190f2a5b-bbc8-65c7-fcb0-97891307b917Product name120140508

FDA-Initiated Inactive NDC Indexing#

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
62750-044-10ZicamCold Remedy Rapidmelts Citrus1 in 1 CARTONTABLET18
62750-044-10ZicamCold Remedy Rapidmelts Citrus25 in 1 BOTTLE, PLASTICTABLET258
62750-044-11ZicamCold Remedy Rapidmelts Citrus45 in 1 BOTTLE, PLASTICTABLET458
62750-044-11ZicamCold Remedy Rapidmelts Citrus1 in 1 CARTONTABLET18
62750-044-12ZicamCold Remedy Rapidmelts Citrus5 in 1 BLISTER PACKTABLET58
62750-044-12ZicamCold Remedy Rapidmelts Citrus1 in 1 CARTONTABLET18
62750-044-14ZicamCold Remedy Rapidmelts Citrus1 in 1 CARTONTABLET18
62750-044-14ZicamCold Remedy Rapidmelts Citrus56 in 1 BOTTLE, PLASTICTABLET568
62750-044-16ZicamCold Remedy Rapidmelts Citrus1 in 1 CARTONTABLET18
62750-044-16ZicamCold Remedy Rapidmelts Citrus12 in 1 BOTTLE, PLASTICTABLET128

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
62750-044ZICAM COLD REMEDY RAPIDMELTS CITRUS (ZINC ACETATE ANHYDROUS AND ZINC GLUCONATE) TABLET [MATRIXX INITIATIVES, INC.]8Legacy NDC, 10 package rows20230129_df466117-4549-409e-b911-f767d7e3894b.zip

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
62750-044-10EA - Each62750-044eca01e7e-82db-4eec-a780-272f2107c9b212024-06-10

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIISPL versionUploaded
ZINC ACETATE ANHYDROUSACTIVE INGREDIENTH2ZEY72PME1
ZINC GLUCONATEACTIVE INGREDIENTU6WSN5SQ1Z1
ZINCACTIVE MOIETYJ41CSQ7QDS1
ammonium glycyrrhizateINACTIVE INGREDIENT3VRD35U26C1
ascorbic acidINACTIVE INGREDIENTPQ6CK8PD0R1
crospovidoneINACTIVE INGREDIENT68401960MK1
FD&C Yellow No. 6INACTIVE INGREDIENTH77VEI93A81
magnesium stearateINACTIVE INGREDIENT70097M6I301
mannitolINACTIVE INGREDIENT3OWL53L36A1
sodium starch glycolate type A potatoINACTIVE INGREDIENT5856J3G2A21
stearic acidINACTIVE INGREDIENT4ELV7Z65AP1
sucraloseINACTIVE INGREDIENT96K6UQ3ZD41

Products#

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

DailyMed product names page 1 of 1 · 15 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
62750-04462750-044-10, 62750-044-11, 62750-044-12, 62750-044-14, 62750-044-16

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 12 matching rows.

Source Document#

Source XML · Source PDF

Inactive ingredient matches#

Inactive Ingredient Database values describe FDA-listed use contexts. The match method and ambiguity count are shown because ingredient names, routes, and dosage forms are not always unique. Browse recovered IID releases and source provenance.

Inactive ingredient links page 1 of 4 · 211 matching rows.

DailyMed ingredient, IID ingredient, UNII table
DailyMed ingredientIID ingredientUNIIDosage form / routePotencyMaximum daily exposureMatch
mannitolMANNITOL3OWL53L36AINJECTION, SOLUTION / SUBCUTANEOUS99 mgExact identifier — unii candidate
65 equally ranked IID candidates
mannitolMANNITOL3OWL53L36ACAPSULE, EXTENDED RELEASE / ORAL160 mgExact identifier — unii candidate
65 equally ranked IID candidates
stearic acidSTEARIC ACID4ELV7Z65APSHAMPOO / TOPICAL9.7 %w/wExact identifier — unii candidate
26 equally ranked IID candidates
stearic acidSTEARIC ACID4ELV7Z65APTABLET, CHEWABLE / ORAL180 mgExact identifier — unii candidate
26 equally ranked IID candidates
mannitolMANNITOL3OWL53L36ACAPSULE / ORAL1562 mgExact identifier — unii candidate
65 equally ranked IID candidates
mannitolMANNITOL3OWL53L36ATABLET, ORALLY DISINTEGRATING / ORAL4364 mgExact identifier — unii candidate
65 equally ranked IID candidates
sucraloseSUCRALOSE96K6UQ3ZD4TABLET / ORAL45 mgExact identifier — unii candidate
22 equally ranked IID candidates
sucraloseSUCRALOSE96K6UQ3ZD4POWDER, FOR SUSPENSION / ORAL400 mgExact identifier — unii candidate
22 equally ranked IID candidates
magnesium stearateMAGNESIUM STEARATE70097M6I30INHALANT / ORAL0.08 mgExact identifier — unii candidate
39 equally ranked IID candidates
mannitolMANNITOL3OWL53L36ATABLET, FILM COATED, EXTENDED RELEASE / ORAL543 mgExact identifier — unii candidate
65 equally ranked IID candidates
FD&C Yellow No. 6FD&C YELLOW NO. 6H77VEI93A8POWDER, FOR SOLUTION / ORAL40 mgExact identifier — unii candidate
34 equally ranked IID candidates
magnesium stearateMAGNESIUM STEARATE70097M6I30POWDER / RESPIRATORY (INHALATION)0.13 mgExact identifier — unii candidate
39 equally ranked IID candidates
magnesium stearateMAGNESIUM STEARATE70097M6I30GRANULE / ORAL629 mgExact identifier — unii candidate
39 equally ranked IID candidates
mannitolMANNITOL3OWL53L36APOWDER, FOR SUSPENSION / INTRAMUSCULAR6.75 %w/vExact identifier — unii candidate
65 equally ranked IID candidates
sucraloseSUCRALOSE96K6UQ3ZD4TABLET, EXTENDED RELEASE / ORAL1 mgExact identifier — unii candidate
22 equally ranked IID candidates
mannitolMANNITOL3OWL53L36ACAPSULE, COATED PELLETS / ORAL14 mgExact identifier — unii candidate
65 equally ranked IID candidates
stearic acidSTEARIC ACID4ELV7Z65APCAPSULE / ORAL90 mgExact identifier — unii candidate
26 equally ranked IID candidates
sucraloseSUCRALOSE96K6UQ3ZD4SPRAY, METERED / NASAL2 mgExact identifier — unii candidate
22 equally ranked IID candidates
mannitolMANNITOL3OWL53L36APOWDER, FOR SOLUTION / ORAL3767 mgExact identifier — unii candidate
65 equally ranked IID candidates
mannitolMANNITOL3OWL53L36ATABLET, ORALLY DISINTEGRATING / SUBLINGUAL10.25 mgExact identifier — unii candidate
65 equally ranked IID candidates
magnesium stearateMAGNESIUM STEARATE70097M6I30POWDER / TOPICAL104 mgExact identifier — unii candidate
39 equally ranked IID candidates
ascorbic acidASCORBIC ACIDPQ6CK8PD0RCONCENTRATE / ORAL6 mg/1mlExact identifier — unii candidate
25 equally ranked IID candidates
FD&C Yellow No. 6FD&C YELLOW NO. 6H77VEI93A8TABLET, ORALLY DISINTEGRATING / ORAL12 mgExact identifier — unii candidate
34 equally ranked IID candidates
mannitolMANNITOL3OWL53L36AINJECTION, SOLUTION / INTRAVENOUS15400 mgExact identifier — unii candidate
65 equally ranked IID candidates
sucraloseSUCRALOSE96K6UQ3ZD4GRANULE / ORAL5.4 mgExact identifier — unii candidate
22 equally ranked IID candidates
sucraloseSUCRALOSE96K6UQ3ZD4TABLET, ORALLY DISINTEGRATING / ORAL60 mgExact identifier — unii candidate
22 equally ranked IID candidates
magnesium stearateMAGNESIUM STEARATE70097M6I30GRANULE, FOR SUSPENSION / ORAL14 mgExact identifier — unii candidate
39 equally ranked IID candidates
magnesium stearateMAGNESIUM STEARATE70097M6I30CAPSULE, DELAYED RELEASE / ORAL1060 mgExact identifier — unii candidate
39 equally ranked IID candidates
mannitolMANNITOL3OWL53L36ASUSPENSION, EXTENDED RELEASE / ORAL2464.6 mgExact identifier — unii candidate
65 equally ranked IID candidates
stearic acidSTEARIC ACID4ELV7Z65APTABLET / ORAL336 mgExact identifier — unii candidate
26 equally ranked IID candidates
mannitolMANNITOL3OWL53L36AINJECTION / INTRAMUSCULAR106.6 mgExact identifier — unii candidate
65 equally ranked IID candidates
magnesium stearateMAGNESIUM STEARATE70097M6I30POWDER, FOR SUSPENSION / ORAL120 mgExact identifier — unii candidate
39 equally ranked IID candidates
ascorbic acidASCORBIC ACIDPQ6CK8PD0RSYRUP / ORAL200 mgExact identifier — unii candidate
25 equally ranked IID candidates
FD&C Yellow No. 6FD&C YELLOW NO. 6H77VEI93A8TABLET / SUBLINGUAL1 mgExact identifier — unii candidate
34 equally ranked IID candidates
mannitolMANNITOL3OWL53L36AINJECTION, POWDER, FOR SOLUTION / PARENTERAL200 mgExact identifier — unii candidate
65 equally ranked IID candidates
mannitolMANNITOL3OWL53L36AINJECTION, POWDER, FOR SUSPENSION / SUBCUTANEOUS180 mgExact identifier — unii candidate
65 equally ranked IID candidates
stearic acidSTEARIC ACID4ELV7Z65APCREAM / TOPICAL190 mgExact identifier — unii candidate
26 equally ranked IID candidates
stearic acidSTEARIC ACID4ELV7Z65APTABLET, FILM COATED / ORAL176 mgExact identifier — unii candidate
26 equally ranked IID candidates
mannitolMANNITOL3OWL53L36ATABLET / BUCCAL360 mgExact identifier — unii candidate
65 equally ranked IID candidates
ascorbic acidASCORBIC ACIDPQ6CK8PD0RTABLET, ORALLY DISINTEGRATING / ORAL2.35 mgExact identifier — unii candidate
25 equally ranked IID candidates
mannitolMANNITOL3OWL53L36AINJECTION, POWDER, FOR SOLUTION / SUBCUTANEOUS35 mgExact identifier — unii candidate
65 equally ranked IID candidates
mannitolMANNITOL3OWL53L36AINJECTION, POWDER, LYOPHILIZED, FOR SOLUTION / INTRAVENOUS15400 mgExact identifier — unii candidate
65 equally ranked IID candidates
mannitolMANNITOL3OWL53L36AGEL / OPHTHALMIC25 mgExact identifier — unii candidate
65 equally ranked IID candidates
ascorbic acidASCORBIC ACIDPQ6CK8PD0RSOLUTION / TOPICAL0.04 %w/wExact identifier — unii candidate
25 equally ranked IID candidates
mannitolMANNITOL3OWL53L36ASPRAY / NASAL41.5 mgExact identifier — unii candidate
65 equally ranked IID candidates
sucraloseSUCRALOSE96K6UQ3ZD4GUM, CHEWING / BUCCAL70 mgExact identifier — unii candidate
22 equally ranked IID candidates
mannitolMANNITOL3OWL53L36AINJECTION, SOLUTION / SUBMUCOSAL2.94 %w/vExact identifier — unii candidate
65 equally ranked IID candidates
FD&C Yellow No. 6FD&C YELLOW NO. 6H77VEI93A8SOAP / TOPICAL0.2 %w/wExact identifier — unii candidate
34 equally ranked IID candidates
mannitolMANNITOL3OWL53L36AINJECTION, POWDER, FOR SOLUTION / INTRAMUSCULAR300 mgExact identifier — unii candidate
65 equally ranked IID candidates
ascorbic acidASCORBIC ACIDPQ6CK8PD0RSUSPENSION, EXTENDED RELEASE / ORAL6 mgExact identifier — unii candidate
25 equally ranked IID candidates
magnesium stearateMAGNESIUM STEARATE70097M6I30TABLET, ORALLY DISINTEGRATING, DELAYED RELEASE / ORAL47 mgExact identifier — unii candidate
39 equally ranked IID candidates
magnesium stearateMAGNESIUM STEARATE70097M6I30TABLET, EXTENDED RELEASE / ORAL173 mgExact identifier — unii candidate
39 equally ranked IID candidates
FD&C Yellow No. 6FD&C YELLOW NO. 6H77VEI93A8CONCENTRATE / ORAL0.03 mg/5mlExact identifier — unii candidate
34 equally ranked IID candidates
FD&C Yellow No. 6FD&C YELLOW NO. 6H77VEI93A8TABLET, EXTENDED RELEASE / ORAL8 mgExact identifier — unii candidate
34 equally ranked IID candidates
sucraloseSUCRALOSE96K6UQ3ZD4GRANULE, FOR SUSPENSION / ORAL23 mgExact identifier — unii candidate
22 equally ranked IID candidates
mannitolMANNITOL3OWL53L36ASOLUTION / SUBCUTANEOUS4.54 %w/vExact identifier — unii candidate
65 equally ranked IID candidates
mannitolMANNITOL3OWL53L36ASUSPENSION / OPHTHALMIC9 mgExact identifier — unii candidate
65 equally ranked IID candidates
sucraloseSUCRALOSE96K6UQ3ZD4FILM / ORAL1 mgExact identifier — unii candidate
22 equally ranked IID candidates
FD&C Yellow No. 6FD&C YELLOW NO. 6H77VEI93A8CAPSULE, EXTENDED RELEASE / ORAL4.59 mgExact identifier — unii candidate
34 equally ranked IID candidates
FD&C Yellow No. 6FD&C YELLOW NO. 6H77VEI93A8TABLET / ORAL60.02 mgExact identifier — unii candidate
34 equally ranked IID candidates

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
ceef53f6-433a-465d-afc2-f7cfb9225fc4df466117-4549-409e-b911-f767d7e3894b2023-01-26WarningsExact identifier
spl id: ceef53f6-433a-465d-afc2-f7cfb9225fc4
spl set id: df466117-4549-409e-b911-f767d7e3894b

Reported adverse events (FAERS/openFDA)#

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