ZICAM KIDS COLD RELIEF REMEDY- soft chews tablet, chewable

Zicam Kids Cold Relief Remedy by

Drug Labeling and Warnings

Zicam Kids Cold Relief Remedy by is a Homeopathic medication manufactured, distributed, or labeled by BestCo Inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ACTIVE INGREDIENT

Active ingredients (in each soft chew)

Zincum aceticum 2X

Zincum gluconicum 2X

PURPOSE

Purpose

Relieves cold symptoms

INDICATIONS & USAGE

Uses

• temporarily relieves symptoms of the common cold
• nasal congestion
• runny nose
• scratchy throat

WARNINGS

Zicam Cold Remedy Relief KIDS was formulated to relieve symptoms of the common cold and was not formulated to be effective for flu or allergies.

ASK DOCTOR

Ask a doctor before use if your child has a sensitivity to zinc or is allergic to zinc.

STOP USE

Stop use and ask a doctor if symptoms persist or are accompanied by a fever or new symptoms occur

KEEP OUT OF REACH OF CHILDREN

Keep out of reach of children.

OVERDOSAGE

In case of overdose, get medical help or contact a Poison Control Center right away.

DOSAGE & ADMINISTRATION

Directions

• for best results, use at the first sign of a cold and continue to use until symptoms completely subside
• children 6-11 years of age (with adult supervision)
• take 1 soft chew at the onset of symptoms
• chew thoroughly before swallowing
• repeat every 3 hours; not to exceed more than 4 doses in 24 hours
• 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 6 years of age; do not use.

OTHER SAFETY INFORMATION

Other information

• store between 15-29C (59-84F)
• avoid freezing and excessive heat

INACTIVE INGREDIENT

Inactive ingredients

citric acid, corn syrup, corn syrup solids, FD&C blue no. 1, FD&C red no. 40, flavor, glycerin, hydrogenated coconut oil, malic acid, purified water, soy lecithin, sucralose, sucrose

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

ZICAM KIDS COLD RELIEF REMEDY 
soft chews tablet, chewable

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 52642-231
Route of Administration	ORAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
ZINC ACETATE (UNII: FM5526K07A) (ZINC CATION - UNII:13S1S8SF37)	ZINC ACETATE	3.54 mg
ZINC GLUCONATE (UNII: U6WSN5SQ1Z) (ZINC CATION - UNII:13S1S8SF37)	ZINC GLUCONATE	4.5 mg

Inactive Ingredients
Ingredient Name	Strength
SUCROSE (UNII: C151H8M554)

Product Characteristics
Color	purple	Score	score with uneven pieces
Shape	RECTANGLE	Size	22mm
Flavor	GRAPE	Imprint Code	NA
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 52642-231-18	18 in 1 CARTON; Type 0: Not a Combination Product	05/06/2014

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
unapproved homeopathic		05/06/2014

Labeler - BestCo Inc. (002149136)

Registrant - BestCo Inc. (002149136)

Establishment
Name	Address	ID/FEI	Business Operations
BestCo Inc.		002149136	manufacture(52642-231)