ADVANCED HOMEOPATHIC COLD-EEZE- zincum gluconicum 2x lozenge

ADVANCED HOMEOPATHIC COLD-EEZE by

Drug Labeling and Warnings

ADVANCED HOMEOPATHIC COLD-EEZE by is a Homeopathic medication manufactured, distributed, or labeled by ADVANCED FIRST AID, INC., Ultra Seal Corporation, Pharmaloz Manufacturing, Inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ACTIVE INGREDIENT

Active Ingredient (in each tablet) - Zincum Gluconicum 2x (13.3mg)

PURPOSE

homeopathic cold remedy

INDICATIONS & USAGE

Uses:

• reduce the duration of the common cold
• reduce the severity of cold symptoms: cough, sore throat, stuffy nose, sneezing, post nasal drip and/or hoarseness

WARNINGS

Warnings:

• Cold-Eeze lozenges are formulated to reduce the duration of common cold smptoms and may be insufficient treatment for influenza or allergies.

Ask a doctor before use if you:

• are taking monocycline, tetracycline, doxycycline or are on coumadin therapy, zinc treatment may inhibit the absorption of these medications.

Stop use and ask a doctor if:

• symptoms persist beyond 7 days

If pregnant or breastfeeding, ask a healthcare professional before use.

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)
• repeat ever 2-4 hours as needed until all symptoms subside
• completely dissolve lozenge in mouth (do not chew)
• recommended daily dosage is 6 lozenges for adults and 4 lozenges for ages 12-17

OTHER SAFETY INFORMATION

• to avoid minor stomach upset, do not dissolve lozenge on an empty stomach
• do not eat or drink for 15 minutes after use
• store in a cool dry place after opening

INACTIVE INGREDIENT

Inactive Ingredients: corn syrup, glycine, natural flavors and sucrose. No artificial colors or preservatives.

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

ADVANCED HOMEOPATHIC COLD-EEZE 
zincum gluconicum 2x lozenge

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 67060-122
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
CORN SYRUP (UNII: 9G5L16BK6N)
GLYCINE (UNII: TE7660XO1C)
SUCROSE (UNII: C151H8M554)

Product Characteristics
Color	white	Score	no score
Shape	OVAL	Size	23mm
Flavor	FRUIT	Imprint Code	P
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 67060-122-39	25 in 1 CARTON	09/16/2019
1	NDC: 67060-122-01	1 in 1 PACKET; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
unapproved homeopathic		09/16/2019

Labeler - ADVANCED FIRST AID, INC. (114477180)

Registrant - ADVANCED FIRST AID, INC. (114477180)

Establishment
Name	Address	ID/FEI	Business Operations
Ultra Seal Corporation		085752004	pack(67060-122)

Establishment
Name	Address	ID/FEI	Business Operations
Pharmaloz Manufacturing, Inc.		067101998	manufacture(67060-122)