FDA.reportPublic FDA data

Zicam Cold Remedy Medicated Fruit Drops

Manufacturer
Matrixx Initiatives, Inc. | BestCo
Effective date
2022-01-27
Label type
HUMAN OTC DRUG LABEL
Version
3
Source
legacy-cache
Hydrated at
2026-08-01 22:11:05

Label at a glance#

ProductZicam Cold Remedy Medicated Fruit Drops
Active ingredientZINC ACETATE ANHYDROUS, ZINC GLUCONATE, SAMBUCUS NIGRA FLOWERING TOP
Label structure9 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 one medicated drop at onset of symptoms chew slowly and dissolve completely before swallowing repeat every 2 – 3 hours, not to exceed 5 medicated drops in 24 hours. Take until symptoms are gone. to avoid minor stomach upset, do not take on an empty stomach do n...

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

OTC - ACTIVE INGREDIENT SECTION

OTC - PURPOSE SECTION

Active ingredients (in each medicated drop)Purpose
Zincum aceticum 2x
Zincum gluconicum 2x		Reduces duration and severity of the common cold
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
  • 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 one medicated drop at onset of symptoms
    • chew slowly and dissolve completely before swallowing
    • repeat every 2 – 3 hours, not to exceed 5 medicated drops 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, dextrose, dicalcium phosphate, disodium phosphate, FD&C Blue #1, FD&C Red #40, malic acid, menthol, natural flavors, pectin, purified water, sodium citrate, sodium polyphosphate, sucralose, sucrose

SPL UNCLASSIFIED SECTION

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

PRINCIPAL DISPLAY PANEL - 25 Drop Bottle Label

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

GREAT TASTING!

NDC 62750-085-10

Plus Natural Power of
ELDERBERRY*

ZICAM®
COLD REMEDY

SHORTENS COLDS

TAKE AT THE FIRST
SIGN OF A COLD

THE
PRE-COLD®
MEDICINE

MEDICATED
FRUIT DROPS

*NATURAL ELDERBERRY FLAVOR

25 DROPS • HOMEOPATHIC

PRINCIPAL DISPLAY PANEL - 25 Drop Bottle Label
PRINCIPAL DISPLAY PANEL - 25 Drop Bottle Label

Products#

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

DailyMed product names page 1 of 1 · 21 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
62750-08562750-085-10

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 18 matching rows.

Name, UNII, Kind table
NameUNIIKind
ZINC ACETATE ANHYDROUSH2ZEY72PMEACTIM
ZINC GLUCONATEU6WSN5SQ1ZACTIB
SAMBUCUS NIGRA FLOWERING TOPCT03BSA18UACTIB
CITRIC ACID MONOHYDRATE2968PHW8QPIACT
CORN SYRUP9G5L16BK6NIACT
DEXTROSE, UNSPECIFIED FORMIY9XDZ35W2IACT
ANHYDROUS DIBASIC CALCIUM PHOSPHATEL11K75P92JIACT
SODIUM PHOSPHATE, DIBASIC, ANHYDROUS22ADO53M6FIACT
FD&C BLUE NO. 1H3R47K3TBDIACT
FD&C RED NO. 40WZB9127XOAIACT
MALIC ACID817L1N4CKPIACT
MENTHOL, UNSPECIFIED FORML7T10EIP3AIACT
PECTIN89NA02M4RXIACT
WATER059QF0KO0RIACT
SODIUM CITRATE, UNSPECIFIED FORM1Q73Q2JULRIACT
SODIUM POLYMETAPHOSPHATEP1BM4ZH95LIACT
SUCRALOSE96K6UQ3ZD4IACT
SUCROSEC151H8M554IACT

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
1ca2de2f-dfb9-493c-985a-575a5d3984a37afa50ee-4aa1-46a7-939f-677a212be8f22022-01-27WarningsExact identifier
spl id: 1ca2de2f-dfb9-493c-985a-575a5d3984a3
spl set id: 7afa50ee-4aa1-46a7-939f-677a212be8f2

Reported adverse events (FAERS/openFDA)#

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