Ultra Cold Remedy Rapidmelts

Manufacturer: Izeen Pharma, Inc.
Effective date: 2015-02-05
Label type: HUMAN OTC DRUG LABEL
Version: 1
Source: full-release
Hydrated at: 2026-06-01 02:06:21

Label at a glance#

ProductUltra Cold Remedy Rapidmelts

Active ingredientZINC ACETATE, ZINC GLUCONATE

Label structure11 sections

Indications and uses

reduces duration of the common cold reduces the severity of cold symptoms: sore throat stuffy nose sneezing coughing nasal congestion Zicam ® ULTRA Cold Remedy was formulated to shorten the duration of the common cold and was not formulated to be effective for flu or allergies.

Dosage and administration

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 4-6 hours, not to exceed 4 tablets in 24 hours to avoid minor stomach upset, do not take on an empty stomach do not eat or drink for 15 minutes af...

Storage and handling

store between 15-29° (59-84°F)

Contacts and useful links#

PhoneLabel contact1-844-287-0260

Label contents#

Full prescribing information#

SPL UNCLASSIFIED SECTION

Drug Facts

Active ingredients (in each tablet)

OTC - ACTIVE INGREDIENT SECTION

Zincum aceticum 2x
Zincum gluconicum 1x

Purpose

OTC - PURPOSE SECTION

Reduces duration and severity of the common cold

Uses

INDICATIONS & USAGE SECTION

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

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

Warnings

WARNINGS SECTION

Ask a doctor before use if you have

OTC - ASK DOCTOR SECTION

a sensitivity to zinc or are allergic to zinc

OTC - STOP USE SECTION

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

OTC - PREGNANCY OR BREAST FEEDING SECTION

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

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

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

Directions

DOSAGE & ADMINISTRATION SECTION

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 4-6 hours, not to exceed 4 tablets in 24 hours
- 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

STORAGE AND HANDLING SECTION

store between 15-29° (59-84°F)

Inactive ingredients

INACTIVE INGREDIENT SECTION

artificial flavor, crospovidone, FD&C red no. 40 aluminum lake, magnesium stearate, mannitol, monoammonium glycyrrhizinate, sodium starch glycolate, stearic acid, sucralose

Questions/Comments

OTC - QUESTIONS SECTION

Questions/Comments call 1-844-287-0260

SPL UNCLASSIFIED SECTION

Manufactured by Izeen Pharma, Inc. 6900 English Muffin Way, Unit A, Frederick, MD 21703

PRINCIPAL DISPLAY PANEL - 18 Tablet Carton

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

NDC# 66007-103-18

Principal Display Panel-Carton

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
f47a510b-6679-4664-b2d6-47b5c4afe7cc	Product name	4	20260217
030ce964-9b2d-45aa-b5d3-f78ce03ef61c	Product name	2	20250515
0306390c-dd77-4363-afe0-63c58088b2a1	Product name	1	20220120
503ea967-4b9c-48cf-9e87-c7975295849d	Product name	2	20220120
190f2a5b-bbc8-65c7-fcb0-97891307b917	Product name	1	20140508

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDC	Effective	Action	Document	Indexing SPL	Related label
66007-103-18	2020-01-31	C162847	48780-1	9d75b9d0-0175-f424-e053-dadaa90a57ce	Ultra Zinc Cold Remedy Fast Melting -Cherry Flavor

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
66007-103-18	Ultra Cold Remedy Rapidmelts	18 in 1 BOTTLE, PLASTIC	TABLET	18		1
66007-103-18	Ultra Cold Remedy Rapidmelts	1 in 1 CARTON	TABLET	1		1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
66007-103	ULTRA COLD REMEDY RAPIDMELTS (ZINC ACETATE AND ZINC GLUCONATE) TABLET [IZEEN PHARMA, INC.]	1	Legacy NDC, 2 package rows	20150206_9d81d3ef-bb1a-49ac-92e1-c3d278c4e3f4.zip

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	SPL version
ZINC ACETATE	ACTIVE INGREDIENT	FM5526K07A	1
ZINC GLUCONATE	ACTIVE INGREDIENT	U6WSN5SQ1Z	1
ZINC CATION	ACTIVE MOIETY	13S1S8SF37	1
ALUMINUM OXIDE	INACTIVE INGREDIENT	LMI26O6933	1
AMMONIUM GLYCYRRHIZATE	INACTIVE INGREDIENT	3VRD35U26C	1
CROSPOVIDONE	INACTIVE INGREDIENT	68401960MK	1
FD&C RED NO. 40	INACTIVE INGREDIENT	WZB9127XOA	1
MAGNESIUM STEARATE	INACTIVE INGREDIENT	70097M6I30	1
MANNITOL	INACTIVE INGREDIENT	3OWL53L36A	1
SODIUM STARCH GLYCOLATE TYPE A POTATO	INACTIVE INGREDIENT	5856J3G2A2	1
STEARIC ACID	INACTIVE INGREDIENT	4ELV7Z65AP	1
SUCRALOSE	INACTIVE INGREDIENT	96K6UQ3ZD4	1

Products#

Every source-derived product name is available through these pages.

DailyMed product names page 1 of 1 · 14 matching rows.

Ultra Cold Remedy Rapidmelts
zinc acetate and zinc gluconate
ZINC ACETATE
ZINC CATION
ZINC GLUCONATE
CROSPOVIDONE
FD&C RED NO. 40
ALUMINUM OXIDE
MAGNESIUM STEARATE
MANNITOL
AMMONIUM GLYCYRRHIZATE
SODIUM STARCH GLYCOLATE TYPE A POTATO
STEARIC ACID
SUCRALOSE

NDC Codes#

Product NDC, Package NDC table
Product NDC	Package NDC
66007-103	66007-103-18

Ingredients#

Every source-derived ingredient row is available through these pages.

DailyMed ingredient rows page 1 of 1 · 11 matching rows.

Name, UNII, Kind table
Name	UNII	Kind
ZINC ACETATE	FM5526K07A	ACTIM
ZINC GLUCONATE	U6WSN5SQ1Z	ACTIB
CROSPOVIDONE	68401960MK	IACT
FD&C RED NO. 40	WZB9127XOA	IACT
ALUMINUM OXIDE	LMI26O6933	IACT
MAGNESIUM STEARATE	70097M6I30	IACT
MANNITOL	3OWL53L36A	IACT
AMMONIUM GLYCYRRHIZATE	3VRD35U26C	IACT
SODIUM STARCH GLYCOLATE TYPE A POTATO	5856J3G2A2	IACT
STEARIC ACID	4ELV7Z65AP	IACT
SUCRALOSE	96K6UQ3ZD4	IACT

Source Document#

Source XML

Inactive ingredient matches#

Inactive Ingredient Database values describe FDA-listed use contexts. The match method and ambiguity count are shown because ingredient names, routes, and dosage forms are not always unique. Browse recovered IID releases and source provenance.

Inactive ingredient links page 1 of 4 · 182 matching rows.

DailyMed ingredient, IID ingredient, UNII table
DailyMed ingredient	IID ingredient	UNII	Dosage form / route	Potency	Maximum daily exposure	Match
SUCRALOSE	SUCRALOSE	96K6UQ3ZD4	TABLET, EXTENDED RELEASE / ORAL		1 mg	Exact identifier — unii candidate 22 equally ranked IID candidates
MAGNESIUM STEARATE	MAGNESIUM STEARATE	70097M6I30	TABLET, CHEWABLE / ORAL		127 mg	Exact identifier — unii candidate 39 equally ranked IID candidates
MAGNESIUM STEARATE	MAGNESIUM STEARATE	70097M6I30	TABLET, ORALLY DISINTEGRATING / ORAL		187 mg	Exact identifier — unii candidate 39 equally ranked IID candidates
MANNITOL	MANNITOL	3OWL53L36A	CAPSULE, COATED, EXTENDED RELEASE / ORAL	NA		Exact identifier — unii candidate 65 equally ranked IID candidates
STEARIC ACID	STEARIC ACID	4ELV7Z65AP	TABLET, EXTENDED RELEASE / ORAL		200 mg	Exact identifier — unii candidate 26 equally ranked IID candidates
FD&C RED NO. 40	FD&C RED NO. 40	WZB9127XOA	CAPSULE / ORAL		16 mg	Exact identifier — unii candidate 28 equally ranked IID candidates
MANNITOL	MANNITOL	3OWL53L36A	SOLUTION, CONCENTRATE / INTRAVENOUS		220 mg	Exact identifier — unii candidate 65 equally ranked IID candidates
SUCRALOSE	SUCRALOSE	96K6UQ3ZD4	POWDER, FOR SOLUTION / ORAL		414 mg	Exact identifier — unii candidate 22 equally ranked IID candidates
FD&C RED NO. 40	FD&C RED NO. 40	WZB9127XOA	SPONGE / TOPICAL	NA		Exact identifier — unii candidate 28 equally ranked IID candidates
MANNITOL	MANNITOL	3OWL53L36A	SOLUTION, GEL FORMING / DROPS / OPHTHALMIC		4 mg	Exact identifier — unii candidate 65 equally ranked IID candidates
MANNITOL	MANNITOL	3OWL53L36A	SOLUTION / SUBCUTANEOUS	4.54 %w/v		Exact identifier — unii candidate 65 equally ranked IID candidates
MANNITOL	MANNITOL	3OWL53L36A	SOLUTION / OPHTHALMIC	4.7 %w/v		Exact identifier — unii candidate 65 equally ranked IID candidates
MANNITOL	MANNITOL	3OWL53L36A	INJECTION, POWDER, FOR SUSPENSION / SUBCUTANEOUS		180 mg	Exact identifier — unii candidate 65 equally ranked IID candidates
FD&C RED NO. 40	FD&C RED NO. 40	WZB9127XOA	CAPSULE, LIQUID FILLED / ORAL		1 mg	Exact identifier — unii candidate 28 equally ranked IID candidates
MANNITOL	MANNITOL	3OWL53L36A	INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION / INTRAVENOUS		15400 mg	Exact identifier — unii candidate 65 equally ranked IID candidates
STEARIC ACID	STEARIC ACID	4ELV7Z65AP	AEROSOL, FOAM / TOPICAL	8 %w/w		Exact identifier — unii candidate 26 equally ranked IID candidates
MANNITOL	MANNITOL	3OWL53L36A	SOLUTION / INTRAVENOUS		15400 mg	Exact identifier — unii candidate 65 equally ranked IID candidates
MANNITOL	MANNITOL	3OWL53L36A	GRANULE / ORAL		1328 mg	Exact identifier — unii candidate 65 equally ranked IID candidates
MAGNESIUM STEARATE	MAGNESIUM STEARATE	70097M6I30	SYSTEM / INTRAVITREAL	0.02 mg		Exact identifier — unii candidate 39 equally ranked IID candidates
FD&C RED NO. 40	FD&C RED NO. 40	WZB9127XOA	DROPS / ORAL	NA		Exact identifier — unii candidate 28 equally ranked IID candidates
MANNITOL	MANNITOL	3OWL53L36A	INJECTION, POWDER, FOR SUSPENSION / INTRAVENOUS		181 mg	Exact identifier — unii candidate 65 equally ranked IID candidates
MAGNESIUM STEARATE	MAGNESIUM STEARATE	70097M6I30	IMPLANT / SUBCUTANEOUS	0.5 mg		Exact identifier — unii candidate 39 equally ranked IID candidates
MAGNESIUM STEARATE	MAGNESIUM STEARATE	70097M6I30	TABLET, DELAYED RELEASE / ORAL		144 mg	Exact identifier — unii candidate 39 equally ranked IID candidates
MAGNESIUM STEARATE	MAGNESIUM STEARATE	70097M6I30	INHALANT / ORAL	0.08 mg		Exact identifier — unii candidate 39 equally ranked IID candidates
MAGNESIUM STEARATE	MAGNESIUM STEARATE	70097M6I30	TABLET / ORAL		980 mg	Exact identifier — unii candidate 39 equally ranked IID candidates
SUCRALOSE	SUCRALOSE	96K6UQ3ZD4	SPRAY, METERED / NASAL		2 mg	Exact identifier — unii candidate 22 equally ranked IID candidates
STEARIC ACID	STEARIC ACID	4ELV7Z65AP	TABLET, COATED / ORAL	42.4 mg		Exact identifier — unii candidate 26 equally ranked IID candidates
MAGNESIUM STEARATE	MAGNESIUM STEARATE	70097M6I30	SUSPENSION, EXTENDED RELEASE / ORAL		71 mg	Exact identifier — unii candidate 39 equally ranked IID candidates
SUCRALOSE	SUCRALOSE	96K6UQ3ZD4	TABLET, ORALLY DISINTEGRATING / ORAL		60 mg	Exact identifier — unii candidate 22 equally ranked IID candidates
FD&C RED NO. 40	FD&C RED NO. 40	WZB9127XOA	SUSPENSION/ DROPS / ORAL		1 mg	Exact identifier — unii candidate 28 equally ranked IID candidates
MAGNESIUM STEARATE	MAGNESIUM STEARATE	70097M6I30	INSERT / VAGINAL		69 mg	Exact identifier — unii candidate 39 equally ranked IID candidates
SUCRALOSE	SUCRALOSE	96K6UQ3ZD4	TABLET, CHEWABLE / ORAL		28 mg	Exact identifier — unii candidate 22 equally ranked IID candidates
SUCRALOSE	SUCRALOSE	96K6UQ3ZD4	SUSPENSION / ORAL		383 mg	Exact identifier — unii candidate 22 equally ranked IID candidates
MANNITOL	MANNITOL	3OWL53L36A	INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION / SUBCUTANEOUS		658 mg	Exact identifier — unii candidate 65 equally ranked IID candidates
MANNITOL	MANNITOL	3OWL53L36A	POWDER / RESPIRATORY (INHALATION)		6 mg	Exact identifier — unii candidate 65 equally ranked IID candidates
FD&C RED NO. 40	FD&C RED NO. 40	WZB9127XOA	TABLET, COATED / ORAL	0.1 mg		Exact identifier — unii candidate 28 equally ranked IID candidates
MANNITOL	MANNITOL	3OWL53L36A	GUM, CHEWING / BUCCAL		891 mg	Exact identifier — unii candidate 65 equally ranked IID candidates
MANNITOL	MANNITOL	3OWL53L36A	INJECTION, POWDER, FOR SUSPENSION / INTRAMUSCULAR		164 mg	Exact identifier — unii candidate 65 equally ranked IID candidates
MANNITOL	MANNITOL	3OWL53L36A	INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION / INTRAMUSCULAR		113 mg	Exact identifier — unii candidate 65 equally ranked IID candidates
MANNITOL	MANNITOL	3OWL53L36A	SOLUTION/ DROPS / OPHTHALMIC	4.6 %w/v		Exact identifier — unii candidate 65 equally ranked IID candidates
MANNITOL	MANNITOL	3OWL53L36A	CAPSULE / ORAL		1562 mg	Exact identifier — unii candidate 65 equally ranked IID candidates
FD&C RED NO. 40	FD&C RED NO. 40	WZB9127XOA	CONCENTRATE / ORAL	0.04 mg/1ml		Exact identifier — unii candidate 28 equally ranked IID candidates
SUCRALOSE	SUCRALOSE	96K6UQ3ZD4	GRANULE / ORAL	5.4 mg		Exact identifier — unii candidate 22 equally ranked IID candidates
MAGNESIUM STEARATE	MAGNESIUM STEARATE	70097M6I30	GRANULE / ORAL		629 mg	Exact identifier — unii candidate 39 equally ranked IID candidates
FD&C RED NO. 40	FD&C RED NO. 40	WZB9127XOA	TABLET, FILM COATED / ORAL	2.5 mg		Exact identifier — unii candidate 28 equally ranked IID candidates
MANNITOL	MANNITOL	3OWL53L36A	TABLET, FILM COATED / ORAL		2309 mg	Exact identifier — unii candidate 65 equally ranked IID candidates
ALUMINUM OXIDE	ALUMINUM OXIDE	LMI26O6933	TABLET / ORAL	NA		Exact identifier — unii candidate 2 equally ranked IID candidates
MANNITOL	MANNITOL	3OWL53L36A	TABLET, ORALLY DISINTEGRATING / SUBLINGUAL	10.25 mg		Exact identifier — unii candidate 65 equally ranked IID candidates
SUCRALOSE	SUCRALOSE	96K6UQ3ZD4	FILM / ORAL		1 mg	Exact identifier — unii candidate 22 equally ranked IID candidates
MANNITOL	MANNITOL	3OWL53L36A	CAPSULE, EXTENDED RELEASE / ORAL		160 mg	Exact identifier — unii candidate 65 equally ranked IID candidates
MANNITOL	MANNITOL	3OWL53L36A	TABLET, CHEWABLE, EXTENDED RELEASE / ORAL		616 mg	Exact identifier — unii candidate 65 equally ranked IID candidates
STEARIC ACID	STEARIC ACID	4ELV7Z65AP	EMULSION / ORAL	NA		Exact identifier — unii candidate 26 equally ranked IID candidates
STEARIC ACID	STEARIC ACID	4ELV7Z65AP	SOAP / TOPICAL	6 %w/w		Exact identifier — unii candidate 26 equally ranked IID candidates
FD&C RED NO. 40	FD&C RED NO. 40	WZB9127XOA	CAPSULE, EXTENDED RELEASE / ORAL		1 mg	Exact identifier — unii candidate 28 equally ranked IID candidates
FD&C RED NO. 40	FD&C RED NO. 40	WZB9127XOA	CAPSULE, DELAYED RELEASE / ORAL		2 mg	Exact identifier — unii candidate 28 equally ranked IID candidates
MANNITOL	MANNITOL	3OWL53L36A	TROCHE / ORAL		14594 mg	Exact identifier — unii candidate 65 equally ranked IID candidates
FD&C RED NO. 40	FD&C RED NO. 40	WZB9127XOA	SYRUP / ORAL		3 mg	Exact identifier — unii candidate 28 equally ranked IID candidates
MANNITOL	MANNITOL	3OWL53L36A	SUSPENSION / OPHTHALMIC		9 mg	Exact identifier — unii candidate 65 equally ranked IID candidates
FD&C RED NO. 40	FD&C RED NO. 40	WZB9127XOA	TABLET / BUCCAL	0.01 mg		Exact identifier — unii candidate 28 equally ranked IID candidates
MANNITOL	MANNITOL	3OWL53L36A	POWDER, FOR SUSPENSION / INTRAMUSCULAR	6.75 %w/v		Exact identifier — unii candidate 65 equally ranked IID candidates

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
a2f36978-5282-4e46-b79a-5a593bdf65c3			9d81d3ef-bb1a-49ac-92e1-c3d278c4e3f4	2015-02-05	Warnings	Exact identifier spl id: a2f36978-5282-4e46-b79a-5a593bdf65c3 spl set id: 9d81d3ef-bb1a-49ac-92e1-c3d278c4e3f4

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.