COLD RELIEF- zinc gluconate lozenge

cold relief by

Drug Labeling and Warnings

cold relief by is a Homeopathic medication manufactured, distributed, or labeled by Walgreen Company, Bestco Inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ACTIVE INGREDIENT

Active ingredient (in each lozenge)

Zincum Gluconicum 2X (13.4 mg)

PURPOSE

Purpose

Cold Relief

INDICATIONS & USAGE

Uses

• may help reduce the duration of common cold symptoms
• this product was formulated to help reduce the duration and severity of cold symptoms and was not formulated to be effective for flu or allergies

WARNINGS

Warnings

Ask a doctor before use if you have a sensitivity to zinc or are allergic to zinc or any of the other ingredients in this product

ASK DOCTOR/PHARMACIST

Ask a doctor or pharmacist before use if you are now taking minocycline, doxycycline, tetracycline or are on coumadin therapy; zinc treatment may inhibit the absorption of these medicines

WHEN USING

When using this product

to avaid minor stomach upset, do not dissolve lozenges on an empty stomach

avoid citrus fruits or juices and products containing citric acid 1/2 hour before or after taking, as they may diminish effectiveness

STOP USE

Stop use and ask a doctor if symptoms persist for more than 7 days or are accompanied by a fever

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.

DOSAGE & ADMINISTRATION

Directions

adults and children 12 years and over

for best results, begin treatment at start of symptoms (within 24 - 48 hours of onset)

completely dissolve lozenges in mouth. (Do not swallow whole. Do not chew.)

repeat every 2 - 4 hours as needed until symptoms subside

do not exceed 6 lozenges for adults and 4 lozenges for children ages 12 - 17 in a 24 hour period

for children under 12 years of age, consult a health professional prior to use

OTHER SAFETY INFORMATION

Other information

not formulated to be effective for treatment of influenza or allergies

store in a cool dry place after opening

no artificial colors or preservatives

INACTIVE INGREDIENT

Inactive ingredients: Corn starch, corn syrup, glycine, medium chain triglycerides, natural flavors, purified water, soybean oil and sucrose.

QUESTIONS

Questions? Or to report an adverse event call 1-800-245-2898. Monday through Friday, 9AM to 4PM EST

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

COLD RELIEF 
zinc gluconate lozenge

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 0363-1090
Route of Administration	ORAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
ZINC GLUCONATE (UNII: U6WSN5SQ1Z) (ZINC CATION - UNII:13S1S8SF37)	ZINC GLUCONATE	2 [hp_X]

Inactive Ingredients
Ingredient Name	Strength
SUCROSE (UNII: C151H8M554)

Product Characteristics
Color	white (Semi-Translucent)	Score	no score
Shape	OVAL	Size	16mm
Flavor	CHERRY	Imprint Code	B
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 0363-1090-18	18 in 1 CARTON; Type 0: Not a Combination Product	06/11/2015

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
unapproved homeopathic		06/11/2015

Labeler - Walgreen Company (008965063)

Registrant - Bestco Inc. (002149136)

Establishment
Name	Address	ID/FEI	Business Operations
Bestco Inc.		002149136	manufacture(0363-1090)