Ultra Zinc Cold Therapy Orange Cream Flavor 18 Chewable Tablets

Manufacturer
PHARMACY VALUE ALLIANCE, LLC
Effective date
2021-10-11
Label type
HUMAN OTC DRUG LABEL
Version
3
Source
full-release
Hydrated at
2026-06-01 02:15:06

Label at a glance#

ProductPV Ultra Zinc Cold Therapy
Active ingredientZINC GLUCONATE
Label structure7 sections

Indications and uses

▪ may help reduce duration 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 absorption of the...

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 tablets 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 ju...

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 (14mg Zinc)

Purpose

OTC - PURPOSE SECTION

Cold Remedy

Uses

INDICATIONS & USAGE SECTION

  • may help reduce duration 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

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 tablets 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, 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 68016-692-18

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

ULTRA ZINC COLD THERAPY

May help reduce duration and severity of cold symptoms**

ORANGE CREAM flavor

Naturally and Artificially Flavored

  • Sugar Free
  • Day Free
  • Homeopathic†

18 CHEWABLE TABLETS

Package Contains One Bottle

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

If for any reason you are not satisfied with this product, please return it to the store where purchased for a full refund.

Premier Value Ultra Zinc Cold Therapy 18 counts
Premier Value Ultra Zinc Cold Therapy 18 counts

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

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
68016-692-182023-01-30C16284748780-1f386c64a-38e4-0266-e053-dadaa90a7c1aUltra Zinc Cold Therapy Orange Cream Flavor 18 Chewable Tablets

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
68016-692-18PV Ultra Zinc Cold Therapy18 in 1 BOTTLE, PLASTICTABLET, CHEWABLE183

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
68016-692PV ULTRA ZINC COLD THERAPY (ZINCUM GLUCONICUM) TABLET, CHEWABLE [PHARMACY VALUE ALLIANCE, LLC]3Legacy NDC, 1 package rows20211012_5a08516b-a641-4238-8e06-ece27a163ba2.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
68016-69268016-692-18

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 7 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
36d87d9e-d591-4bb0-ace7-362e446c8f735a08516b-a641-4238-8e06-ece27a163ba22021-10-11WarningsExact identifier
spl id: 36d87d9e-d591-4bb0-ace7-362e446c8f73
spl set id: 5a08516b-a641-4238-8e06-ece27a163ba2

Reported adverse events (FAERS/openFDA)#

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