ZICAM COLD REMEDY- galphimia glauca flowering top, luffa operculata fruit, and schoenocaulon officinale seed spray

Zicam Cold Remedy by

Drug Labeling and Warnings

Zicam Cold Remedy by is a Homeopathic medication manufactured, distributed, or labeled by Matrixx Initiatives, Inc., Accupac, Inc. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

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Drug Facts

Active ingredients

Galphimia glauca 4x, Luffa operculata 4x, Sabadilla 4x

Purpose

Reduces duration and severity of the common cold

Uses

• reduces duration of the common cold
• reduces severity of cold symptoms:
  • dry, scratchy throat
  • runny nose
  • watery eyes
  • sneezing
  • nasal congestion

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

Warnings

• For nasal use only

Do not use if you have a sensitivity or allergy to any of the ingredients. If an allergic reaction occurs, stop use and seek medical help right away.

Ask a doctor before use if you have

• ear, nose, or throat sensitivity
• susceptibility to nosebleeds

When using this product

• avoid contact with eyes. Rinse right away with water if it gets in eyes and seek medical help right away.
• the use of this container by more than one person may spread infection
• temporary discomfort such as burning, stinging, sneezing, or an increase in nasal discharge may occur

Stop use and ask a doctor if

• symptoms get worse or last more than 7 days or are accompanied by fever
• redness or swelling is present
• new symptoms occur

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

Keep out of reach of children. If swallowed, 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:
  • remove cap and safety clip
  • hold with thumb at bottom of bottle and nozzle between your fingers
  • before using the first time, prime pump by depressing several times
  • place tip of nozzle just past nasal opening (approximately 1/8")
  • lean your head backwards slightly
  • pump 2 times into each nostril
  • avoid inhaling deeply
  • wipe away any excess
  • dose every 3 hours, not to exceed 5 doses in one 24 hour period
• children under 12 years of age: do not use

Other information

• store at room temperature 15-29°C (59-84°F)

Inactive ingredients

benzalkonium chloride, dibasic sodium phosphate, eucalyptol, eugenol, glycine, hypromellose, menthol, monobasic sodium phosphate, phenethyl alcohol, polysorbate 80, purified water, saccharin sodium, sodium chloride, succinic acid

Questions? Comments? Side Effects?

call 877-942-2626 toll free

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Distributed by Matrixx Initiatives, Inc.
Scottsdale, Arizona 85260.

PRINCIPAL DISPLAY PANEL - 15 mL Bottle Carton

NDC: 62750-070-10

ZICAM®
COLD REMEDY

SHORTENS COLDS

PLUS MULTI-SYMPTOM RELIEF

GET BETTER
FASTER

TAKE AT THE FIRST

THE
PRE-COLD®
MEDICINE

SIGN OF A COLD

THE
ONLY
CLINICALLY
PROVEN
COLD SHORTENING
NASAL SPRAY

SEE
WHAT'S
INSIDE!

No Drip
NASAL SPRAY

With Cooling Menthol
& Eucalyptus

0.50 FL OZ (15 mL)

ZINC-FREE
HOMEOPATHIC

INGREDIENTS AND APPEARANCE

ZICAM COLD REMEDY 
galphimia glauca flowering top, luffa operculata fruit, and schoenocaulon officinale seed spray

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 62750-070
Route of Administration	NASAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
GALPHIMIA GLAUCA FLOWERING TOP (UNII: 93PH5Q8M7E) (GALPHIMIA GLAUCA FLOWERING TOP - UNII:93PH5Q8M7E)	GALPHIMIA GLAUCA FLOWERING TOP	4 [hp_X]  in 0.56 mL
LUFFA OPERCULATA FRUIT (UNII: C4MO6809HU) (LUFFA OPERCULATA FRUIT - UNII:C4MO6809HU)	LUFFA OPERCULATA FRUIT	4 [hp_X]  in 0.56 mL
SCHOENOCAULON OFFICINALE SEED (UNII: 6NAF1689IO) (SCHOENOCAULON OFFICINALE SEED - UNII:6NAF1689IO)	SCHOENOCAULON OFFICINALE SEED	4 [hp_X]  in 0.56 mL

Inactive Ingredients
Ingredient Name	Strength
BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7)
SODIUM PHOSPHATE, DIBASIC, UNSPECIFIED FORM (UNII: GR686LBA74)
EUCALYPTOL (UNII: RV6J6604TK)
EUGENOL (UNII: 3T8H1794QW)
GLYCINE (UNII: TE7660XO1C)
HYPROMELLOSE, UNSPECIFIED (UNII: 3NXW29V3WO)
MENTHOL, UNSPECIFIED FORM (UNII: L7T10EIP3A)
SODIUM PHOSPHATE, MONOBASIC, UNSPECIFIED FORM (UNII: 3980JIH2SW)
PHENYLETHYL ALCOHOL (UNII: ML9LGA7468)
POLYSORBATE 80 (UNII: 6OZP39ZG8H)
WATER (UNII: 059QF0KO0R)
SACCHARIN SODIUM (UNII: SB8ZUX40TY)
SODIUM CHLORIDE (UNII: 451W47IQ8X)
SUCCINIC ACID (UNII: AB6MNQ6J6L)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 62750-070-10	1 in 1 CARTON	08/01/2014
1		15 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
UNAPPROVED HOMEOPATHIC		08/01/2014

Labeler - Matrixx Initiatives, Inc. (790037253)

Establishment
Name	Address	ID/FEI	Business Operations
Accupac, Inc		071609663	MANUFACTURE(62750-070)