Hy-Vee, Inc. Cold Remedy Drug Facts

Drug Labeling and Warnings

Drug Details [pdf]

COLD REMEDY- zincum aceticum, zincum gluconicum tablet, orally disintegrating 
HyVee Inc

Disclaimer: This homeopathic product has not been evaluated by the Food and Drug Administration for safety or efficacy. FDA is not aware of scientific evidence to support homeopathy as effective.

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Hy-Vee, Inc. Cold Remedy Drug Facts

Active ingredients (in each tablet)

Zincum aceticum 2x

Zincum gluconicum 1x

Purpose

Reduces duration and may reduce severity of the common cold

Uses

• reduces duration of the common cold
• may reduce the severity of cold symptoms:
• sore throat
• stuffy nose
• sneezing
• coughing
• nasal congestion

This product was formulated to shorten the duration of the common cold and was not formulated to be effective for flu or allergies.

Warnings

Ask a doctor before use if you have

a sensitivity to zinc or are allergic to zinc

Stop use and ask a doctor if

symptoms persist or are accompanied by a fever or new symptoms occur

If pregnant or breast-feeding,

ask a health professional before use.

Keep out of reach of children.

In case of overdose, get medical help or contact a Poison Control Center right away (1-800-222-1222).

Directions

• for best results, use at the first sign of a cold and continue to use until symptoms completely subside
• adults and children 12 years of age and older:
• take 1 tablet at the onset of symptoms
• dissolve entire tablet in mouth. Do not chew. Do not swallow whole.
• repeat every 3 hours until symptoms are gone
• 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 12 years of age: ask a doctor before use

Other information

• store at 20-25°C (68-77°F)

Inactive ingredients

crospovidone, dextrates, flavors, magnesium stearate, polyethylene glycol, sodium lauryl sulfate, sodium starch glycolate, sucralose

Questions or comments?

1-800-719-9260

Principal Display Panel

COMPARE TO the Active Ingredients of Zicam® Cold Remedy

Cold Remedy

Zincum Aceticum

Zincum Gluconicum

Reduces the Duration of a Cold

ACTUAL SIZE

Take at the First Sign of a Cold

Homeopathic

Cherry Flavor

25 QUICK DISSOLVE TABLETS

COLD REMEDY 
zincum aceticum, zincum gluconicum tablet, orally disintegrating

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 42507-807
Route of Administration	ORAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
ZINC ACETATE (UNII: FM5526K07A) (ZINC CATION - UNII:13S1S8SF37)	ZINC ACETATE	2 [hp_X]
ZINC GLUCONATE (UNII: U6WSN5SQ1Z) (ZINC CATION - UNII:13S1S8SF37)	ZINC GLUCONATE	1 [hp_X]

Inactive Ingredients
Ingredient Name	Strength
CROSPOVIDONE (15 MPA.S AT 5%) (UNII: 68401960MK)
DEXTRATES (UNII: G263MI44RU)
MAGNESIUM STEARATE (UNII: 70097M6I30)
POLYETHYLENE GLYCOL (UNII: 3WJQ0SDW1A)
SODIUM LAURYL SULFATE (UNII: 368GB5141J)
SUCRALOSE (UNII: 96K6UQ3ZD4)

Product Characteristics
Color	WHITE	Score	no score
Shape	ROUND	Size	16mm
Flavor	CHERRY	Imprint Code	C2
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 42507-807-01	1 in 1 CARTON	08/11/2008	05/01/2019
1		25 in 1 BOTTLE; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Unapproved homeopathic		08/11/2008	05/01/2019

Labeler - HyVee Inc (006925671)

Revised: 12/2018

Document Id: d66f9d87-c8d7-4c86-b1f6-37f867b44842

34390-5

Set id: 985fcea9-2db1-4b2f-968a-c9f645c2bb5a

Version: 4

Effective Time: 20181210