FDA.reportPublic FDA data

LEADER Zinc Cold Therapy Citrus Flavor 25 Chewable Tablets

Manufacturer
CARDINAL HEALTH
Effective date
2025-10-14
Label type
HUMAN OTC DRUG LABEL
Version
8
Source
full-release
Hydrated at
2026-06-01 02:37:06

Label at a glance#

ProductZinc Cold Therapy
Active ingredientZINC GLUCONATE
Label structure9 sections

Indications and uses

may help reduce duration and severity of cold symptoms sore throat stuffy nose sneezing coughing This product was formulated to help reduce the duration and severity of cold symptoms 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 as directed adults and children 12 years of age and older: chew one tablet at the onset of symptoms 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, dr...

Storage and handling

do not take zinc tablets on an empty stomach to avoid possible minor stomach upset. store at room temperature

Label contents#

Full prescribing information#

SPL UNCLASSIFIED SECTION

Drug Facts

OTC - ACTIVE INGREDIENT SECTION

OTC - PURPOSE SECTION

Active ingredient (in each tablet)Purpose

Cold Remedy

Zincum Gluconicum 1x( 11 mg Zinc)

Uses

INDICATIONS & USAGE SECTION

  • may help reduce duration and severity of cold symptoms
    • sore throat
    • stuffy nose
    • sneezing
    • coughing
  • This product was formulated to help reduce the duration and severity of cold symptoms 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

OTC - ASK DOCTOR SECTION

OTC - ASK DOCTOR SECTION
  • a sensitivity to zinc or are allergic to zinc
  • are taking minocycline, doxycycline, tetracycline or are on Coumadin therapy, zinc treatment may inhibit the absorption of these medicines.

OTC - STOP USE SECTION

Stop use and ask a doctorif symptoms persist beyond 7 days.

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 at 1-800-222-1222

Directions

DOSAGE & ADMINISTRATION SECTION

  • For best results, use at the first sign of a cold and continue to use as directed
    • adults and children 12 years of age and older:
      • chew one tablet at the onset of symptoms
      • 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
      • recommended daily dose is 6 tablets for adults and 4 tablets for ages 12 through 17
    • Children under 12 years of age:Consult a doctor before use.

Other information

STORAGE AND HANDLING SECTION

  • do not take zinc tablets on an empty stomach to avoid possible minor stomach upset.
  • store at room temperature

Inactive ingredients

INACTIVE INGREDIENT SECTION

ascorbic acid, crospovidone, FD&C yellow # 6 lake, magnesium stearate, natural and artificial flavor sorbitol, starch, sucralose

Questions or comments?

OTC - QUESTIONS SECTION

1-866-467-2748

PRINCIPAL DISPLAY PANEL

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

COMPARE TO ZICAM ®COLD REMEDY RAPID MELTS Ionizable Zinc Content *
Zinc Cold Therapy

Zincum Gluconicum

Citrus
Flavor

Naturally and Artificially Flavored

May help reduce duration and severity of cold symptoms**

  • Sugar Free
  • Homeopathic†

25CHEWABLE TABLETS

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

**THIS PRODUCT IS A HOMEOPATHIC REMEDY, AS SUCH, IT HAS NOT UNDERGONE REVIEW ON APPROVAL BY THE FDA AND THEREFORE HAS NOT BEEN DEMONSTRATED TO BE SAFE OR EFFECTIVE TO DIAGNOSE, TREAT, PREVENT, MITIGATE OR CURE ANY CONDITION OR DISEASE.

†CLAIM IS BASED ONLY ON THEORIES OF HOMEOPATHY FROM 1700S NOT ACCEPTED BY MOST MODERN MEDICAL EXPERTS. THERE IS NO SCIENTIFIC EVIDENCE THAT THE PRODUCT WORKS

IMPORTANT: Keep this carton for future reference on full labeling.

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

  • CardinalHealth ™

DISTRIBUTED BY CARDINAL HEALTH

DUBLIN,OHIO 43017

www.myleader.com1-800-200-6313

Essential to care ™ since 1979

Leader Zinc Cold Therapy Citrus Flavor 25 Chewable Tablets
Leader Zinc Cold Therapy Citrus Flavor 25 Chewable Tablets

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
c5cd4727-ac49-4409-82b1-5bd8006c3ec7Product name120171122
190f2a5b-bbc8-65c7-fcb0-97891307b917Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
70000-0391-1Zinc Cold Therapy25 in 1 BOTTLE, PLASTICTABLET258

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
70000-0391-1EA - Each70000-039175f22c3b-0288-46c5-8d5b-f00078e1b89d12019-09-05

Products#

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

DailyMed product names page 1 of 1 · 10 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
70000-039170000-0391-1

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 8 matching rows.

Name, UNII, Kind table
NameUNIIKind
ASCORBIC ACIDPQ6CK8PD0RIACT
CROSPOVIDONE (120 .MU.M)68401960MKIACT
FD&C YELLOW NO. 6H77VEI93A8IACT
MAGNESIUM STEARATE70097M6I30IACT
SORBITOL506T60A25RIACT
STARCH, CORNO8232NY3SJIACT
SUCRALOSE96K6UQ3ZD4IACT
ZINC GLUCONATEU6WSN5SQ1ZACTIB

Source Document#

Source XML

Older Hydrated Versions#

Version, Effective date, Source table
VersionEffective dateSourceHydrated
72024-11-21full-release2026-06-01 02:29:00

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
280a49de-94a3-4a4e-bdf2-cdf2c18859f771e688a9-fb91-4dbf-b9c6-983e42366b5b2026-09-10WarningsExact identifier
spl set id: 71e688a9-fb91-4dbf-b9c6-983e42366b5b

Reported adverse events (FAERS/openFDA)#

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