Label: ZICAM- zinc acetate and zinc gluconate tablet, orally disintegrating
- NDC Code(s): 62750-035-10, 62750-035-11
- 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 1x of a cold
- reduces duration of a cold
- reduces severity of cold symptoms:
- sore throat
- stuffy nose
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:
- Dissolve entire tablet in mouth. Do not chew. Do not swallow whole.
- Take 1 tablet at the onset of symptoms.
- 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.
- Children under 12 years of age: Consult a doctor before use.
- Inactive ingredients
ascorbic acid, crospovidone, echinacea purpurea, FD&C Lake Yellow No. 5 (tartrazine), magnesium stearate, mannitol, mono-ammonium glycyrrhizinate, natural flavor, sodium starch glycolate, stearic acid, sucraloseClose
- STORAGE AND HANDLING
Store at room temperature 15°C-29°C (59°F-84°F)Close
- Questions? Comments? Side Effects?
call 877-942-2626 toll free orClose
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- PRINCIPAL DISPLAY PANEL - 25 Tablet Carton
Get rid of your cold faster™
✔ Reduces the duration of a cold
with Vitamin C
25 Quick Dissolve Tablets
- INGREDIENTS AND APPEARANCE
zinc acetate and zinc gluconate tablet, orally disintegrating
Product Information Product Type HUMAN OTC DRUG LABEL Item Code (Source) NDC:62750-035 Route of Administration ORAL DEA Schedule Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength zinc acetate (zinc) zinc acetate 2 [hp_X] zinc gluconate (zinc) zinc gluconate 1 [hp_X] Inactive Ingredients Ingredient Name Strength ascorbic acid crospovidone echinacea purpurea FD&C Yellow No. 5 aluminum oxide magnesium stearate mannitol glycyrrhizin, ammoniated stearic acid sucralose Product Characteristics Color YELLOW Score no score Shape ROUND Size 15mm Flavor LEMON Imprint Code Z Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:62750-035-10 1 in 1 CARTON 1 25 in 1 BOTTLE, PLASTIC 2 NDC:62750-035-11 1 in 1 CARTON 2 45 in 1 BOTTLE, PLASTIC Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date Unapproved homeopathic 11/07/2008 Labeler - Matrixx Initiatives, Inc. (790037253) Establishment Name Address ID/FEI Business Operations Nutritional Labs International 007306970 Manufacture Establishment Name Address ID/FEI Business Operations TLC Labs, Inc 169896730 Analysis Establishment Name Address ID/FEI Business Operations Boston Analytical, Inc. 147830830 Analysis