FDA Label for Zinc Cold Therapy Citrus Flavor
View Indications, Usage & Precautions
Zinc Cold Therapy Citrus Flavor Product Label
The following document was submitted to the FDA by the labeler of this product Raritan Pharmaceuticals Inc. 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
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
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?
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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
* Please review the disclaimer below.