ZICAM COLD REMEDY SOFT CHEWS- zincum aceticum, zincum gluconicum, caffeinum tablet, chewable

Zicam Cold Remedy Soft Chews by

Drug Labeling and Warnings

Zicam Cold Remedy Soft Chews 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 1X

Caffeinum 5X

PURPOSE

Purpose

Reduces duration and severity of the common cold

Helps restore mental alertness

INDICATIONS & USAGE

Uses

• reduces duration of the common cold
• reduces severity of cold symptoms: sore throat, stuffy nose, sneezing, coughing, nasal congestion
• helps restore mental alertness when experiencing fatigue or drowsiness

WARNINGS

Zicam Cold Remedy was formulated to shorten the duration of the common cold and was not formulated to be effective for flu or allergies.

ASK DOCTOR

Ask a doctor before use if you have a sensitivity to zinc or are allergic to zinc

STOP USE

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

PREGNANCY OR BREAST FEEDING

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

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 to use until symptoms completely subside
• adults and children 12 years of age and older:
• take 2 soft chews at the onset of symptoms
• chew thoroughly before swallowing
• repeat every 2-6 hours, not to exceed 4 doses in 24 hours. Take until symptoms are gone.
• to avoid minor stomach upset, do not take on any 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: ask a doctor before use.

OTHER SAFETY INFORMATION

Other information

• store between 15-29C (59-84F)

INACTIVE INGREDIENT

Inactive ingredients

cocoa powder, coconut oil, corn syrup, corn syrup solids, glycerin, natural and artificial flavors, purified water, soy lecithin, sucralose, sucrose

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

ZICAM COLD REMEDY SOFT CHEWS 
zincum aceticum, zincum gluconicum, caffeinum tablet, chewable

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 52642-232
Route of Administration	ORAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
ZINC ACETATE (UNII: FM5526K07A) (ZINC CATION - UNII:13S1S8SF37)	ZINC ACETATE	3.53 mg
CAFFEINE (UNII: 3G6A5W338E) (CAFFEINE - UNII:3G6A5W338E)	CAFFEINE	0.03 mg
ZINC GLUCONATE (UNII: U6WSN5SQ1Z) (ZINC CATION - UNII:13S1S8SF37)	ZINC GLUCONATE	4.47 mg

Inactive Ingredients
Ingredient Name	Strength
SUCROSE (UNII: C151H8M554)

Product Characteristics
Color	brown	Score	score with uneven pieces
Shape	RECTANGLE	Size	20mm
Flavor	CHOCOLATE	Imprint Code	NA
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 52642-232-32	32 in 1 CARTON; Type 0: Not a Combination Product	04/20/2015

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
unapproved homeopathic		04/20/2015

Labeler - BestCo Inc. (002149136)

Registrant - BestCo Inc. (002149136)

Establishment
Name	Address	ID/FEI	Business Operations
BestCo Inc.		002149136	manufacture(52642-232)