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Drug Facts
Topcare Health Cold Remedy Tablet
FDA Label NDC 36800-805
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Topco Associates Llc for the product Topcare Health Cold Remedy (NDC 36800-805). 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
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
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 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, flavors, magnesium stearate, sorbitol, starch, sucralose.
Questions Or Comments?
1-888-423-0139
Principal Display Panel
TopCare Health™
NDC 36800-805-25
*COMPARE TO ZICAM® COLD REMEDY RAPIDMELTS® ACTIVE INGREDIENT*
HOMEOPATHIC†
Cold Remedy
ZINCUM GLUCONICUM
- Take at the first sign of a cold
- May help reduce the duration of cold symptoms*
✓ QUALITY GUARANTEED
Sugar-Free
CHERRY FLAVOR
NATURALLY & ARTIFICIALLY FLAVORED
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:
TOPCO ASSOCIATES LLC
ELK GROVE VILLAGE, IL 60007
© TOPCO RARA0619 QUESTIONS? 1-888-423-0139
[email protected] www.topcarebrand.com
Topcare Health Cold Remedy Cherry Flavor (Zicam 01)
* Please review the disclaimer below.
