ZICAM COLD REMEDY- zinc acetate anhydrous and zinc gluconate lozenge

Zicam Cold Remedy by

Drug Labeling and Warnings

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

Drug Details [pdf]

SPL UNCLASSIFIED SECTION

Drug Facts

Active ingredients (in each lozenge)

Zincum aceticum 2x

Zincum gluconicum 2x

Purposes

Reduces duration and severity of the common cold

Uses

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

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

Warnings

Sore throat warning

If sore throat is severe, persists for more than 2 days, is accompanied or followed by fever, headache, rash, nausea, or vomiting, consult a doctor promptly.

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, including cough, persist, recur or are accompanied by a fever, rash, or persistent headache, or if new symptoms occur. A persistent cough that lasts for more than one week may be a sign of a serious condition.

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 lozenge at the onset of symptoms. Completely dissolve lozenge in mouth. Do not chew. Do not swallow whole.
  • repeat every 2 – 3 hours, not to exceed 7 lozenges in 24 hours. Take 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 between 15-29°C (59-84°F)
• avoid freezing and excessive heat

Inactive ingredients

citric acid, corn syrup, FD&C blue no. 1, FD&C red no. 40, malic acid, menthol, natural flavors, purified water, sucralose, sucrose

SPL UNCLASSIFIED SECTION

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

PRINCIPAL DISPLAY PANEL - 25 Lozenge Pouch Carton

NDC: 62750-079-10

ZICAM®
COLD REMEDY

SHORTENS COLDS
+ SOOTHES SORE THROATS
AND COUGHS

TAKE AT THE FIRST
SIGN OF A COLD
THE
PRE-COLD®
MEDICINE

CLINICALLY PROVEN
TO SHORTEN COLDS

LOZENGES

GREAT TASTING

Wild Cherry Flavor

HOMEOPATHIC
25
Individually Wrapped
LOZENGES

INGREDIENTS AND APPEARANCE

ZICAM COLD REMEDY 
zinc acetate anhydrous and zinc gluconate lozenge

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 62750-079
Route of Administration	ORAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
ZINC ACETATE ANHYDROUS (UNII: H2ZEY72PME) (ZINC CATION - UNII:13S1S8SF37)	ZINC CATION	2 [hp_X]
ZINC GLUCONATE (UNII: U6WSN5SQ1Z) (ZINC CATION - UNII:13S1S8SF37)	ZINC GLUCONATE	2 [hp_X]

Inactive Ingredients
Ingredient Name	Strength
CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)
CORN SYRUP (UNII: 9G5L16BK6N)
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)
FD&C RED NO. 40 (UNII: WZB9127XOA)
MALIC ACID (UNII: 817L1N4CKP)
MENTHOL, UNSPECIFIED FORM (UNII: L7T10EIP3A)
WATER (UNII: 059QF0KO0R)
SUCRALOSE (UNII: 96K6UQ3ZD4)
SUCROSE (UNII: C151H8M554)

Product Characteristics
Color	RED	Score	no score
Shape	OVAL	Size	22mm
Flavor	CHERRY	Imprint Code	Z
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 62750-079-10	1 in 1 CARTON	02/01/2018
1		25 in 1 POUCH; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
UNAPPROVED HOMEOPATHIC		02/01/2018

Labeler - Matrixx Initiatives, Inc. (790037253)

Establishment
Name	Address	ID/FEI	Business Operations
BestCo		002149136	MANUFACTURE(62750-079)