Premier Value Zinc Cold Therapy Tablet
FDA Label NDC 68016-118

Full FDA labeling including Indications, Dosage, Usage, and Precautions

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Pharmacy Value Alliance, Llc for the product Premier Value Zinc Cold Therapy (NDC 68016-118). This document serves as the official prescribing information, containing essential scientific data and clinical materials required for healthcare providers and patients.

This specific version of the label includes detailed information regarding other, active ingredient, purpose, uses, ask a doctor before use if you have, stop use and ask a doctor, if pregnant or breast feeding, keep out of reach of children, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Label Section Quick Index

Other

Drug Facts

Active Ingredient

Zincum Gluconicum 1x (11mg Zinc)

Purpose

Cold Remedy

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.

Ask A Doctor Before Use If You Have

  • ▪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

If symptoms persist beyond 7 days.

If Pregnant Or Breast Feeding

As ask health professional before use.

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

  • ▪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

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

Inactive Ingredients

ascorbic acid, crospovidone, FD&C Yellow No. 6, flavors, magnesium stearate, sorbitol, starch, sucralose.

Questions Or Comments?

1-866-467-2748

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 (Zicam 01)

    Premier Value Citrus Flavor 25 Chewable Tablets (Zicam 01)

* Please review the disclaimer below.