ZICAM COLD REMEDY MEDICATED FRUIT DROPS- zinc acetate anhydrous, zinc gluconate, and sambucus nigra flowering top bar, chewable

Zicam Cold Remedy Medicated Fruit Drops by

Drug Labeling and Warnings

Zicam Cold Remedy Medicated Fruit Drops 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 INGREDIENT

Active ingredients (in each medicated drop)	Purpose
* Claims based on traditional homeopathic practice, not accepted medical evidence. Not FDA evaluated.
Zincum aceticum 2x; Zincum gluconicum 2x	Reduces duration and severity of the common cold
Sambucus nigra (elderberry) 4x	Helps relieve cold symptoms *

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

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.

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 one medicated drop at onset of symptoms
  • chew slowly and dissolve completely before swallowing
  • repeat every 2 – 3 hours, not to exceed 7 medicated drops 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, dextrose, dicalcium phosphate, disodium phosphate, FD&C Blue #1, FD&C Red #40, malic acid, menthol, natural flavors, pectin, purified water, sodium citrate, sodium polyphosphate, sucralose, sucrose

SPL UNCLASSIFIED SECTION

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

PRINCIPAL DISPLAY PANEL - 25 Drop Bottle Label

NEW!

NDC: 62750-085-10

Plus Natural Power of
ELDERBERRY*

ZICAM®
COLD REMEDY

SHORTENS COLDS

TAKE AT THE FIRST
SIGN OF A COLD

THE
PRE-COLD®
MEDICINE

MEDICATED
FRUIT DROPS

*NATURAL ELDERBERRY FLAVOR

25 DROPS HOMEOPATHIC

INGREDIENTS AND APPEARANCE

ZICAM COLD REMEDY MEDICATED FRUIT DROPS 
zinc acetate anhydrous, zinc gluconate, and sambucus nigra flowering top bar, chewable

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 62750-085
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]
SAMBUCUS NIGRA FLOWERING TOP (UNII: CT03BSA18U) (SAMBUCUS NIGRA FLOWERING TOP - UNII:CT03BSA18U)	SAMBUCUS NIGRA FLOWERING TOP	4 [hp_X]

Inactive Ingredients
Ingredient Name	Strength
CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)
CORN SYRUP (UNII: 9G5L16BK6N)
DEXTROSE, UNSPECIFIED FORM (UNII: IY9XDZ35W2)
ANHYDROUS DIBASIC CALCIUM PHOSPHATE (UNII: L11K75P92J)
SODIUM PHOSPHATE, DIBASIC, ANHYDROUS (UNII: 22ADO53M6F)
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)
FD&C RED NO. 40 (UNII: WZB9127XOA)
MALIC ACID (UNII: 817L1N4CKP)
MENTHOL, UNSPECIFIED FORM (UNII: L7T10EIP3A)
PECTIN (UNII: 89NA02M4RX)
WATER (UNII: 059QF0KO0R)
SODIUM CITRATE, UNSPECIFIED FORM (UNII: 1Q73Q2JULR)
SODIUM POLYMETAPHOSPHATE (UNII: P1BM4ZH95L)
SUCRALOSE (UNII: 96K6UQ3ZD4)
SUCROSE (UNII: C151H8M554)

Product Characteristics
Color	PURPLE	Score	no score
Shape	ROUND	Size	24mm
Flavor	BERRY	Imprint Code	Z
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 62750-085-10	25 in 1 BOTTLE; Type 0: Not a Combination Product	07/20/2019

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
UNAPPROVED HOMEOPATHIC		07/20/2019

Labeler - Matrixx Initiatives, Inc. (790037253)

Establishment
Name	Address	ID/FEI	Business Operations
BestCo		002149136	MANUFACTURE(62750-085)