Label: ZICAM COLD REMEDY- zinc acetate and zinc gluconate bar, chewable
- NDC Code(s): 62750-025-10
- Packager: Matrixx Initiatives, Inc.
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: unapproved homeopathic
NOTE: Most over the counter (OTC) are not reviewed and approved by the FDA. However, they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.
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- SPL UNCLASSIFIED SECTION
- ACTIVE INGREDIENT
Active ingredients Purpose Zincum Aceticum 2x Reduces duration and severity Zincum Gluconicum 2x of a cold
- reduces duration of a cold
- reduces severity of cold symptoms:
- sore throat
- stuffy nose
Stop use and ask a doctor if symptoms persist or are accompanied by fever.
Zicam® Cold Remedy was formulated to shorten the duration of a cold and is not known to be effective for flu or allergies.
- For best results, use at the first sign of a cold and continue to use for an additional 48 hours after symptoms subside.
- Adults and children 12 years of age and older:
- Take 1 chewable square at the onset of symptoms. Chew thoroughly before swallowing.
- 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.
- This product is not recommended for children under 12 years of age due to the hazard of choking.
- Inactive ingredients
coconut oil, corn syrup, corn syrup solids, FD&C red No. 40, glycerin, natural and artificial flavors, purified water, soy lecithin, sucralose, sucrose, sugarClose
- Questions? Comments? Side Effects?
call 877-942-2626 toll free or visit us on the web at www.zicam.comClose
- PRINCIPAL DISPLAY PANEL - 25 Chewable Carton
Get over your cold faster®
Reduces the duration of a cold
- INGREDIENTS AND APPEARANCE
ZICAM COLD REMEDY
zinc acetate and zinc gluconate bar, chewable
Product Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:62750-025 Route of Administration ORAL DEA Schedule Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength zinc acetate (UNII: FM5526K07A) (zinc - UNII:J41CSQ7QDS) zinc acetate 2 [hp_X] zinc gluconate (UNII: U6WSN5SQ1Z) (zinc - UNII:J41CSQ7QDS) zinc gluconate 2 [hp_X] Inactive Ingredients Ingredient Name Strength coconut oil (UNII: Q9L0O73W7L) corn syrup (UNII: 9G5L16BK6N) FD&C red No. 40 (UNII: WZB9127XOA) glycerin (UNII: PDC6A3C0OX) water (UNII: 059QF0KO0R) lecithin, soybean (UNII: 1DI56QDM62) sucralose (UNII: 96K6UQ3ZD4) sucrose (UNII: C151H8M554) Product Characteristics Color RED Score no score Shape RECTANGLE Size 23mm Flavor STRAWBERRY Imprint Code Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:62750-025-10 1 in 1 CARTON 1 25 in 1 BAG Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date Unapproved homeopathic 08/22/2003 Labeler - Matrixx Initiatives, Inc. (790037253) Establishment Name Address ID/FEI Business Operations Best Sweet 002149136 MANUFACTURE Establishment Name Address ID/FEI Business Operations Boston Analytical 147830830 ANALYSIS Establishment Name Address ID/FEI Business Operations TLC Labs, Inc. 169896730 ANALYSIS