FIRST AID DIRECT COLD-EEZE COLD REMEDY- zinc gluconate lozenge

First Aid Direct Cold-EEZE Cold Remedy by

Drug Labeling and Warnings

First Aid Direct Cold-EEZE Cold Remedy by is a Homeopathic medication manufactured, distributed, or labeled by Cintas Corporation, Pharmaloz Manufacturing, Inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ACTIVE INGREDIENT

Active ingredient (per lozenge)

Zinc Gluconate 2X HPUS† (2.3%) 13.3 mg zinc)

†The letters 'HPUS' indicate that the active ingredient is in the official Homeopathic Pharmacopeia of the United States.

PURPOSE

Purpose

Cold remedy

INDICATIONS & USAGE

Uses

• reduces the duration of the common cold
• reduces the severity of cold symptoms: cough, sore throat, nasal congestion, post nasal drip and/or hoarseness

Warnings

Do not use for treatment of influenza or allergies. This product is intended only to reduce the duration of the common cold and its symptoms

Ask a doctor or pharmacist before use if you are taking minocycline, doxycycline, tetracycline or are on Coumadin (warfarin) therapy. Zinc treatment may inhibit the absorption of these medicines. 

When using this product do not take on an empty stomach (to avoid possible minor stomach upset)

Stop use and ask your doctor if symptoms persist more than 7 days

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

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

DOSAGE & ADMINISTRATION

Directions

• take one lozenge at the onset of symptoms
• dissolve entire lozenge in mouth
• do not chew
• do not swallow whole
• do not eat or drink for 15 minutes after use
• repeat every 2-4 hours until symptoms subside
• Adults 18 years and over: do not exceed 6 lozenges per day
• Children 12 to under 18 years: do not exceed 4 lozenges per day
• Children under 12 years: ask a doctor before use

OTHER SAFETY INFORMATION

Other information

• store in a cool, dry place after opening
• best if used within 6 months after opening

INACTIVE INGREDIENT

Inactive ingredients

corn syrup, glycine, natural flavors, sucrose

QUESTIONS

Questions?

1-800-327-2704 m-F 8am-5pm EST

Principal Display Panel

Cold-EEZE®

Cold Remedy Lozenge

Zinc Gluconate Homeeopathic

NATURAL CHERRY FLAVOR

Formulated to reduce the duration of the common cold when taken at the first sign of symptoms.

20 Lozenges per box

Cold-EEZE® is a registered trademark of Vespyr Brands®, Inc.

1192000

INGREDIENTS AND APPEARANCE

FIRST AID DIRECT COLD-EEZE COLD REMEDY 
zinc gluconate lozenge

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 42961-105
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)
CHERRY (UNII: BUC5I9595W)

Product Characteristics
Color	white (Semi-Translucent)	Score	no score
Shape	OVAL	Size	23mm
Flavor	CHERRY	Imprint Code	P
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 42961-105-02	20 in 1 PACKAGE	07/20/2023
1	NDC: 42961-105-01	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		07/20/2023

Labeler - Cintas Corporation (056481716)

Establishment
Name	Address	ID/FEI	Business Operations
Pharmaloz Manufacturing, Inc.		067101998	manufacture(42961-105)