FDA Label for Zinc Cold Remedy

View Indications, Usage & Precautions

Zinc Cold Remedy Product Label

The following document was submitted to the FDA by the labeler of this product Cardinal Health. The document includes published materials associated whith this product with the essential scientific information about this product as well as other prescribing information. Product labels may durg indications and usage, generic names, contraindications, active ingredients, strength dosage, routes of administration, appearance, warnings, inactive ingredients, etc.

Other



Drug Facts


Otc - Purpose



Active ingredients Purpose

Zincum Aceticum 2x

May reduce duration and severity of cold symptoms**

Zincum Gluconicum 1x


Uses



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

Otc - Ask Doctor



a sensitivity to zinc or are allergic to zinc


Otc - Stop Use



Stop use and ask a doctor if symptoms persist or are accompanied by fever.


Otc - Pregnancy Or Breast Feeding



If pregnant or breast-feeding, ask a health professional before use.


Otc - Keep Out Of Reach Of Children



Keep out of reach of children. In case of overdose, get medical help or contact a Poison ControlCenterright away (1-800-222-1222)


Directions



  • 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



  • •Store at room temperature

Inactive Ingredients



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


Questions Or Comments?



1-866-467-2748


Principal Display Panel - 25 Tablet Carton



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®

* Please review the disclaimer below.