ULTRA COLD REMEDY RAPIDMELTS- zinc acetate and zinc gluconate tablet

Ultra Cold Remedy Rapidmelts by

Drug Labeling and Warnings

Ultra Cold Remedy Rapidmelts by is a Homeopathic medication manufactured, distributed, or labeled by Izeen Pharma, Inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

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Drug Facts

Active ingredients (in each tablet)

Zincum aceticum 2x
Zincum gluconicum 1x

Purpose

Reduces duration and severity of the common cold

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.

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 fever

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.

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 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

• store between 15-29° (59-84°F)

Inactive ingredients

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

Questions/Comments

Questions/Comments call 1-844-287-0260

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

PRINCIPAL DISPLAY PANEL - 18 Tablet Carton

NDC# 66007-103-18

INGREDIENTS AND APPEARANCE

ULTRA COLD REMEDY RAPIDMELTS 
zinc acetate and zinc gluconate tablet

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 66007-103
Route of Administration	ORAL

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

Inactive Ingredients
Ingredient Name	Strength
CROSPOVIDONE (UNII: 68401960MK)
FD&C RED NO. 40 (UNII: WZB9127XOA)
ALUMINUM OXIDE (UNII: LMI26O6933)
MAGNESIUM STEARATE (UNII: 70097M6I30)
MANNITOL (UNII: 3OWL53L36A)
AMMONIUM GLYCYRRHIZATE (UNII: 3VRD35U26C)
SODIUM STARCH GLYCOLATE TYPE A POTATO (UNII: 5856J3G2A2)
STEARIC ACID (UNII: 4ELV7Z65AP)
SUCRALOSE (UNII: 96K6UQ3ZD4)

Product Characteristics
Color	PINK	Score	no score
Shape	ROUND	Size	15mm
Flavor	CHERRY	Imprint Code	Z
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 66007-103-18	1 in 1 CARTON
1		18 in 1 BOTTLE, PLASTIC

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Unapproved homeopathic		02/06/2015

Labeler - Izeen Pharma, Inc. (079300974)

Establishment
Name	Address	ID/FEI	Business Operations
Izeen Pharma, Inc.		079300974	MANUFACTURE(66007-103)