Cvs Health ™

Cvs Health ™
SPL v7
SPL
SPL Set ID f0122ffc-560d-45db-9a75-9220cc5aac45
Route
ORAL
Published
Effective Date 2019-05-18
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Zinc Cation (1 [hp_X])
Inactive Ingredients
Ascorbic Acid Crospovidone (120 .mu.m) Magnesium Stearate Sorbitol Starch, Corn Sucralose

Identifiers & Packaging

Pill Appearance
Imprint: r8 Shape: round Color: white Size: 16 mm Score: 1
Marketing Status
UNAPPROVED HOMEOPATHIC Active Since 2019-04-18

Description

Drug Facts

Purpose

Cold Remedy


Medication Information

Purpose

Cold Remedy

Description

Drug Facts

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.
Section 42229-5

Drug Facts

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.
Active Ingredient

Zincum Gluconicum 1x (14mg Zinc)

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, magnesium stearate, flavors, sorbitol, starch ,sucralose.

Questions Or Comments?

1-866-467-2748

Principal Display Panel

CVS Health

NDC 69842-691-18

*Compare to Zicam ®Cold Remedy RapidMelts ®Ionizable Zinc Content**

SUGAR FREE

Non-Drowsy

ULTRA Cold Remedy

ZINCUM GLUCONICUM

  • Take at the first sign of a cold
  • May help reduce the duration of cold symptoms*
  • Non-habit forming
  • No known drug interactions

Orange Cream Flavor

Homeopathic†

18CHEWABLE 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:

CVS Pharmacy, Inc.

One CVS Drive

Woonsocket, RI 02895

© 2019 CVS/pharmacy

CVS.com ®1-800-SHOP CVS

V-12431

CVS Quality Money Back Guarantee

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.

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.

Structured Label Content

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.
Section 42229-5 (42229-5)

Drug Facts

Purpose

Cold Remedy

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.
Active Ingredient

Zincum Gluconicum 1x (14mg Zinc)

Other Information (Other information)
  • do not take zinc tablets on an empty stomach to avoid possible minor stomach upset.
  • store at room temperature
Inactive Ingredients (Inactive ingredients)

ascorbic acid, crospovidone, magnesium stearate, flavors, sorbitol, starch ,sucralose.

Questions Or Comments? (Questions or comments?)

1-866-467-2748

Principal Display Panel (PRINCIPAL DISPLAY PANEL)

CVS Health

NDC 69842-691-18

*Compare to Zicam ®Cold Remedy RapidMelts ®Ionizable Zinc Content**

SUGAR FREE

Non-Drowsy

ULTRA Cold Remedy

ZINCUM GLUCONICUM

  • Take at the first sign of a cold
  • May help reduce the duration of cold symptoms*
  • Non-habit forming
  • No known drug interactions

Orange Cream Flavor

Homeopathic†

18CHEWABLE 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:

CVS Pharmacy, Inc.

One CVS Drive

Woonsocket, RI 02895

© 2019 CVS/pharmacy

CVS.com ®1-800-SHOP CVS

V-12431

CVS Quality Money Back Guarantee

Stop Use and Ask A Doctor (Stop Use and ask a doctor)

If symptoms persist beyond 7 days.

If Pregnant Or Breast Feeding (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.

Ask A Doctor Before Use If You Have (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.

Advanced Ingredient Data


Raw Label Data

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