RxNorm Names

Not yet provided

ZICAM COLD REMEDY (zinc acetate and zinc gluconate) bar, chewable
[Matrixx Initiatives, Inc.]

Permanent Link:

http://dailymed.nlm.nih.gov/dailymed/lookup.cfm?setid=0afae05f-88ce-4eb2-bcb6-adf19dc20ced

Category	DEA Schedule	Marketing Status
HUMAN OTC DRUG LABEL		unapproved homeopathic

NOTE:THIS HOMEOPATHIC PRODUCT HAS NOT BEEN EVALUATED BY THE FOOD AND DRUG ADMINISTRATION FOR SAFETY OR EFFICACY. FDA IS NOT AWARE OF SCIENTIFIC EVIDENCE TO SUPPORT HOMEOPATHY AS EFFECTIVE.

Drug Label Sections

Description
Clinical Pharmacology
Indications & Usage
Contraindications
Warnings
Precautions
Adverse Reactions
Overdosage
Dosage & Administration
How Supplied
Patient Counseling Information
Supplemental Patient Material
Boxed Warning
Patient Package Insert
Highlights
Full Table of Contents
Medication Guide

Drug Facts

Active ingredients	Purpose
Zincum Aceticum 2x	Reduces duration and severity
Zincum Gluconicum 2x	of a cold

Uses

reduces duration of a cold
reduces severity of cold symptoms:
- sore throat
- stuffy nose
- sneezing
- coughing
- congestion

Warnings

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.

If pregnant or breast-feeding, ask a health professional before use.

Keep out of reach of children.

Directions

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, sugar

Questions? Comments? Side Effects?

call 877-942-2626 toll free or visit us on the web at www.zicam.com

PRINCIPAL DISPLAY PANEL - 25 Chewable Carton

NDC 62750-025-10

ZICAM®

Cold
Remedy

Get over your cold faster®

Reduces the duration of a cold

Chewables

strawberry
flavor

25 Chewables
Homeopathic

Principal Display Panel - 25 Chewable Carton

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 (zinc)	zinc acetate	2 [hp_X]
zinc gluconate (zinc)	zinc gluconate	2 [hp_X]

Inactive Ingredients
Ingredient Name	Strength
coconut oil
corn syrup
FD&C red No. 40
glycerin
water
lecithin, soybean
sucralose
sucrose

Product Characteristics
Color	RED	Score	no score
Shape	RECTANGLE	Size	23mm
Flavor	STRAWBERRY	Imprint Code
Contains

Packaging
#	Item Code	Package Description
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

Revised: 12/2010

Document Id: 21743d92-9ba1-4bfe-bbf0-6e5cd2f0a350

Set id: 0afae05f-88ce-4eb2-bcb6-adf19dc20ced

Version: 2

Effective Time: 20101229

Matrixx Initiatives, Inc.

Daily Med

Current Medication Information

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