Zicam

Manufacturer
Church & Dwight Co., Inc.
Effective date
2024-01-02
Label type
HUMAN OTC DRUG LABEL
Version
4
Source
full-release
Hydrated at
2026-06-01 02:26:02

Label at a glance#

ProductZicam Cold Remedy Zinc and Elderberry Lozenge
Active ingredientZINC ACETATE ANHYDROUS, ZINC GLUCONATE, SAMBUCUS NIGRA FLOWERING TOP
Label structure9 sections

Indications and uses

Reduces duration of the common cold and helps relieve nasal congestion ------------------------------------------------------------------------------------------------------ Zicam ® Cold Remedy was not formulated to be effective for flu and 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. Completely dissolve lozenge in mouth. Do not chew. Do now 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 stomac...

Storage and handling

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

Label contents#

Full prescribing information#

Active ingredients (in each lozenge)

OTC - ACTIVE INGREDIENT SECTION

Zincum aceticum 2x

Zincum gluconicum 2x

Sambucus nigra (elderberry) 4x

Purpose

OTC - PURPOSE SECTION

Active ingredients (in each tablet)Purpose
Zincum aceticum 2x



Zincum gluconicum 2x
Reduces duration of the common cold and helps relieve nasal congestion
Sambucus nigra (elderberry) 4xHelps relieve cold symptoms *

* Claims based on traditional homeopathic practice, not accepted medical evidence. Not FDA evaluated.

Uses

INDICATIONS & USAGE SECTION

Reduces duration of the common cold and helps relieve nasal congestion

------------------------------------------------------------------------------------------------------

Zicam ® Cold Remedy was not formulated to be effective for flu and allergies.

Warnings

WARNINGS SECTION

Sore throat warning: 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.

OTC - ASK DOCTOR SECTION

If you are allergic or sensitive to zinc, consult a doctor before using.

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 tablet at the onset of symptoms. Completely dissolve lozenge in mouth. Do not chew. Do now 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)
  • avoid freezing and excessive heat

Inactive ingredients

INACTIVE INGREDIENT SECTION

citric acid, corn syrup, FD&C Blue No. 1, FD&C Red No. 40, flavor, glycerin, malic acid, purified water, soy lecithin, sucralose, sucrose

Questions? Comments?

OTC - QUESTIONS SECTION

call 877-942-2626 toll free

www.zicam.com

PRINCIPAL DISPLAY PANEL - 25 INDIVIDUALLY WRAPPED CENTER FILLED LOZENGES

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

NEW!

Plus ELDERBERRY

ZICAM®

COLD REMEDY

PRE-COLD®

FIGHTER

ZINC &

ELDERBERRY

LOZENGE

Elderberry Flavor

HOMEOPATHIC

TAKE AT

THE FIRST SIGN

25 INDIVIDUALLY WRAPPED

CENTER FILLED

LOZENGES

7404 ZicLozElderberry25ctCrtn-FNL_AR.jpg7404 ZicLozElderberry25ctCrtn-FNL_AR.jpg

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
10237-462-25Zicam Cold Remedy Zinc and Elderberry Lozenge25 in 1 POUCHLOZENGE254
10237-462-25Zicam Cold Remedy Zinc and Elderberry Lozenge1 in 1 CARTONLOZENGE14

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
10237-462ZICAM COLD REMEDY ZINC AND ELDERBERRY LOZENGE (ZINC ACETATE ANHYDROUS, ZINC GLUCONATE, AND SAMBUCUS NIGRA FLOWERING TOP) LOZENGE [CHURCH & DWIGHT CO., INC.]4Current NDC, Legacy NDC, 2 package rows20240209_c8091b9d-f240-e479-e053-2a95a90a037a.zip

Products#

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

DailyMed product names page 1 of 1 · 17 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
10237-46210237-462-25

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 14 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
Zicam Cold Remedy Zinc and Elderberry LozengeZINC ACETATE ANHYDROUS, ZINC GLUCONATE, AND SAMBUCUS NIGRA FLOWERING TOPChurch & Dwight Co., Inc.c8091b9d-f240-e479-e053-2a95a90a037a2024-01-02WarningsExact identifier
ndc (package): 10237-462-25
ndc (product): 10237-462
ndc11 (package): 10237046225
spl id: b64de477-e6ec-45df-929d-5a57427117a1
spl set id: c8091b9d-f240-e479-e053-2a95a90a037a

Reported adverse events (FAERS/openFDA)#

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