FDA.reportPublic FDA data

LEADER Zinc Cold Remedy Citrus Flavor 25 Quick Dissolving Tablets

Manufacturer
CARDINAL HEALTH
Effective date
2017-05-15
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
legacy-cache
Hydrated at
2026-08-02 01:16:25

Label at a glance#

ProductZinc Cold Remedy
Active ingredientZINC ACETATE ANHYDROUS, ZINC GLUCONATE
Label structure9 sections

Indications and uses

• may reduce duration of cold symptoms • may reduce severity of cold symptoms: • sore throat • stuffy nose • sneezing • coughing • nasal congestion

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 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 af...

Storage and handling

• Store at room temperature

Label contents#

Full prescribing information#

SPL UNCLASSIFIED SECTION

Drug Facts

OTC - ACTIVE INGREDIENT SECTION

OTC - PURPOSE SECTION

Active ingredients Purpose

Zincum Aceticum 2x

May reduce duration and severity of cold symptoms**

Zincum Gluconicum 1x

Uses

INDICATIONS & USAGE SECTION

  • may reduce duration of cold symptoms
  • may reduce severity of cold symptoms:
    • sore throat
    • stuffy nose
    • sneezing
    • coughing
    • nasal congestion

Warnings

WARNINGS SECTION

OTC - ASK DOCTOR SECTION

Ask a doctor before use if you have

OTC - ASK DOCTOR SECTION

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 persist or are accompanied by fever.

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 ControlCenterright away (1-800-222-1222)

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 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: Consult a doctor before use.

Other information

STORAGE AND HANDLING SECTION

  • Store at room temperature

Inactive ingredients

INACTIVE INGREDIENT SECTION

ascorbic acid, crospovidone, FD&C yellow # 6 lake, flavors, magnesium stearate, sorbitol, starch ,sucralose

Questions or comments?

OTC - QUESTIONS SECTION

1-866-467-2748

PRINCIPAL DISPLAY PANEL - 25 Tablet Carton

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

NDC 70000-0130-1

COMPARE TO ZICAM® COLD REMEDY RAPIDMELTS®* active ingredients


Zinc Cold Remedy

Zincum Aceticum

Zincum Gluconicum

Citrus
Flavor

Naturally and Artificially Flavored

May reduce duration and severity of cold symptoms**

Fast -Melting Tablets with Vitamin C

Homeopathic

25 QUICK- DISSOLVING TABLETS

DO NOT USE IF PRINTED INNER SEAL UNDER CAP IS BROKEN OR MISSING

**This statement has not been evaluated by the Food and Drug Administration, This product is not intended to diagnose, treat, cure or prevent any disease.

*This product is not manufactured or distributed by Zicam, LLC, owner of the registered trademarks Zicam® Cold Remedy Rapidmelts®

  • © 2017 CARDINAL HEALTH, the Cardinal Health LOGO, LEADER, and the Leader LOGO
  • are trademarks or registered trademarks of Cardinal Health.
  • CARDINAL HEALTH™
  • DISTRIBUTED BY CARDINAL HEALTH

DUBLIN, OHIO 43017

www.myleader.com

1-800-200-6313

Essential to Care™ since 1979

All Leader Brand Products have a 100% Money Back Guarantee

Return to place of purchase if not satisfied

Leader Zinc Cold Remedy Citrus Flavor 25 Quick Dissolving tablets
Leader Zinc Cold Remedy Citrus Flavor 25 Quick Dissolving tablets

Product Linked Resources#

Resource, Code type, Value table
ResourceCode typeValueEquivalent identifiersSource image
BarcodeEAN-130096295129434GTIN-13: 0096295129434
EAN-13: 0096295129434
GTIN-12: 096295129434
UPC-A: 096295129434
GTIN storage (14 digits): 00096295129434		zicam-01.jpg

Products#

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

DailyMed product names page 1 of 1 · 12 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
70000-013070000-0130-1

Ingredients#

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

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

Name, UNII, Kind table
NameUNIIKind
ZINC ACETATE ANHYDROUSH2ZEY72PMEACTIM
ZINC GLUCONATEU6WSN5SQ1ZACTIB
ascorbic acidPQ6CK8PD0RIACT
crospovidone68401960MKIACT
FD&C Yellow No. 6H77VEI93A8IACT
magnesium stearate70097M6I30IACT
SORBITOL506T60A25RIACT
STARCH, CORNO8232NY3SJIACT
sucralose96K6UQ3ZD4IACT

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
7c01f995-9ada-43ec-9e91-b14701f1136a9a45bf4a-435e-419f-b9b7-340d528572302025-01-15WarningsExact identifier
spl set id: 9a45bf4a-435e-419f-b9b7-340d52857230

Reported adverse events (FAERS/openFDA)#

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