Zicam® Cold Remedy Medicated Fruit Drops

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]

ZICAM COLD REMEDY MEDICATED FRUIT DROPS- zinc acetate anhydrous and zinc gluconate bar, chewable 
Matrixx Initiatives, Inc.

Disclaimer: This homeopathic product has not been evaluated by the Food and Drug Administration for safety or efficacy. FDA is not aware of scientific evidence to support homeopathy as effective.

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Zicam® Cold Remedy Medicated Fruit Drops

Drug Facts

Active ingredients (in each medicated drop)

Zincum aceticum 2x
Zincum gluconicum 2x

Purpose

Reduces duration and severity of the common cold

Uses

  • reduces duration of the common cold
  • reduces 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 3 hours 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, D&C Yellow #10, dextrose, dicalcium phosphate, disodium phosphate, FD&C Blue #1, FD&C Red #40, FD&C Yellow #6, malic acid, menthol, natural flavors, pectin, purified water, sodium citrate, sodium polyphosphate, sucralose, sucrose

Questions? Comments? Side Effects?

call 877-942-2626 toll free www.zicam.com

Distributed by
Matrixx Initiatives, Inc.
Scottsdale, Arizona 85260

PRINCIPAL DISPLAY PANEL - 25 Drop Bottle Label

NEW!

NDC: 62750-077-11

ZICAM®
COLD REMEDY

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

MEDICATED
FRUIT DROPS
ASSORTED FRUIT FLAVORS

25 DROPS HOMEOPATHIC

PRINCIPAL DISPLAY PANEL - 25 Drop Bottle Label
ZICAM COLD REMEDY MEDICATED FRUIT DROPS 
zinc acetate anhydrous and zinc gluconate bar, chewable
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC: 62750-077
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ZINC ACETATE ANHYDROUS (UNII: H2ZEY72PME) (ZINC CATION - UNII:13S1S8SF37) ZINC CATION2 [hp_X]
ZINC GLUCONATE (UNII: U6WSN5SQ1Z) (ZINC CATION - UNII:13S1S8SF37) ZINC GLUCONATE2 [hp_X]
Inactive Ingredients
Ingredient NameStrength
CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)  
CORN SYRUP (UNII: 9G5L16BK6N)  
D&C YELLOW NO. 10 (UNII: 35SW5USQ3G)  
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)  
FD&C YELLOW NO. 6 (UNII: H77VEI93A8)  
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
ColorORANGE, RED, YELLOWScoreno score
ShapeROUNDSize24mm
FlavorCITRUS, CHERRY, LEMONImprint Code RD
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC: 62750-077-1125 in 1 BOTTLE; Type 0: Not a Combination Product04/01/201708/10/2019
2NDC: 62750-077-125 in 1 POUCH; Type 0: Not a Combination Product04/01/201708/10/2019
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
UNAPPROVED HOMEOPATHIC04/01/201708/10/2019
Labeler - Matrixx Initiatives, Inc. (790037253)
Establishment
NameAddressID/FEIBusiness Operations
BestCo002149136MANUFACTURE(62750-077)

Revised: 7/2019
Document Id: 0533094b-8f2c-46e8-b3b5-9c13393b56bd
Set id: ed1da230-d8bb-4c31-bf98-e2fc42d780ad
Version: 2
Effective Time: 20190731
 
Matrixx Initiatives, Inc.