FDA.reportPublic FDA data

Premier Value Zinc Cold Therapy Citrus Flavor 25 Chewable Tablets

Manufacturer
PHARMACY VALUE ALLIANCE, LLC
Effective date
2024-10-28
Label type
HUMAN OTC DRUG LABEL
Version
6
Source
full-release
Hydrated at
2026-06-01 02:28:31

Label at a glance#

ProductPremier Value Zinc Cold Therapy Citrus Flavor
Active ingredientZINC GLUCONATE
Label structure7 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. ▪ a sensitivity to zinc or are allergic zinc ▪ are taking minocycline, doxycycline, tetracycline or are on Coumadin therapy, zinc treatment may inhibit the abso...

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 completely at the onset of symptoms. 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...

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

Active Ingredient

OTC - ACTIVE INGREDIENT SECTION

Zincum Gluconicum 1x (11mg Zinc)

Purpose

OTC - PURPOSE SECTION

Cold Remedy

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

Ask a doctor before use if you have

OTC - ASK DOCTOR SECTION

  • a sensitivity to zinc or are allergic zinc
  • are taking minocycline, doxycycline, tetracycline or are on Coumadin therapy, zinc treatment may inhibit the absorption of these medicines.
Stop Use and ask a doctor

OTC - STOP USE SECTION

If symptoms persist beyond 7 days.

If pregnant or breast feeding

OTC - PREGNANCY OR BREAST FEEDING SECTION

As ask health professional before use.

Keep Out of Reach of Children

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

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 completely at the onset of symptoms. 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.
  • 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 No. 6, flavors, magnesium stearate, sorbitol, starch, sucralose.

Questions or comments?

OTC - QUESTIONS SECTION

1-866-467-2748

PRINCIPAL DISPLAY PANEL

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Premier Value®

NDC 68016-118-25

*COMPARE TO ® IONIZABLE ZINC CONTENT IN ZICAM® COLD REMEDY RAPID MELTS*

ZINC COLD THERAPY
Great Tasting Tablets

May help reduce the duration and severity of cold symptoms**

Citrus Flavor

Naturally and Artificially Flavored

  • Sugar Free
  • Homeopathic†

25 CHEWABLE TABLETS

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

†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

**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.

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®

Distributed By:

Pharmacy Value Alliance, LLC

407 East Lancaster Avenue,

Wayne, PA 19087

Premier Value Citrus Flavor 25 Chewable Tablets
Premier Value 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
68016-118-25Premier Value Zinc Cold TherapyCitrus Flavor25 in 1 BOTTLE, PLASTICTABLET256

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
68016-118PREMIER VALUE ZINC COLD THERAPY CITRUS FLAVOR (ZINC GLUCONATE) TABLET [PHARMACY VALUE ALLIANCE, LLC]6Current NDC, Legacy NDC, 1 package rows20241030_88d9d0ac-15a4-4ae1-93f6-31dfd2195149.zip

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
68016-11868016-118-25

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
ZINC GLUCONATEU6WSN5SQ1ZACTIB
ascorbic acidPQ6CK8PD0RIACT
CROSPOVIDONE (120 .MU.M)68401960MKIACT
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
Premier Value Zinc Cold Therapy Citrus FlavorZINC GLUCONATEPHARMACY VALUE ALLIANCE, LLC88d9d0ac-15a4-4ae1-93f6-31dfd21951492024-10-28WarningsExact identifier
ndc (package): 68016-118-25
ndc (product): 68016-118
ndc11 (package): 68016011825
spl id: 29184052-dbfe-4aba-92e6-83b0babb461e
spl set id: 88d9d0ac-15a4-4ae1-93f6-31dfd2195149

Reported adverse events (FAERS/openFDA)#

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