Zinc Cold Therapy Tablet, Chewable
FDA Label NDC 68163-118

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

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Raritan Pharmaceuticals Inc for the product Zinc Cold Therapy (NDC 68163-118). 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 (in each tablet, purpose, uses, otc - ask doctor, otc - stop use, otc - pregnancy or breast feeding, otc - 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 (In Each Tablet

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.

Otc - Ask Doctor

  • 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

Stop use and ask a doctor if symptoms persist beyond 7 days.

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 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 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

  • 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, flavor, magnesium stearate, sorbitol, starch, sucralose

Questions Or Comments?

1-866-467-2748

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*Compare to Ionizable Zinc Content in Zicam® Cold Remedy Rapid Melts®

DRxCHOICE®

NDC# 68163-118-25

Zinc Cold Therapy

Zincum Gluconicum

May help reduce duration and severity of cold symptoms**

SUGAR FREE

Homeopathic†

Citrus Flavor

Naturally and Artificially Flavored

25 CHEWABLE 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 OR 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®.

Manufactured by:

Raritan Pharmaceuticals

8 Joanna Court,

East Brunswick, NJ 08816

Zinc Cold Therapy Citrus Flavor 25 Chewable Tablets (Zicam 01)

Zinc Cold Therapy Citrus Flavor 25 Chewable Tablets (Zicam 01)

* Please review the disclaimer below.