ZICAM ULTRA COLD REMEDY RAPIDMELTS- zinc acetate anhydrous and zinc gluconate tablet

Zicam Ultra Cold Remedy Rapidmelts by

Drug Labeling and Warnings

Zicam Ultra Cold Remedy Rapidmelts by is a Homeopathic medication manufactured, distributed, or labeled by CHURCH & DWIGHT CO., INC., LNK International, Inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

SPL UNCLASSIFIED SECTION

Drug Facts

Active ingredients (in each tablet)

Zincum aceticum 2x
Zincum gluconicum 1x

Purpose

Reduces duration of the common cold and helps relieve nasal congestion

Uses

• Reduces duration of the common cold and helps relieve nasal congestion

Zicam® ULTRA Cold Remedy was not formulated to be effective for flu or allergies.

Warnings

If you are allergic or sensitive to zinc, consult a doctor before using.

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 1 tablet at the onset of symptoms
  • dissolve entire tablet in mouth. Do not chew. Do not swallow whole.
  • repeat every 2 – 3 hours, not to exceed 7 tablets 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)

Inactive ingredients

crospovidone, flavor, magnesium stearate, mannitol, monoammonium glycyrrhizinate, sodium starch glycolate, stearic acid, sucralose

Questions? Comments?

call 877-942-2626 toll free

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DISTRIBUTED BY CHURCH & DWIGHT CO., INC.
EWING, NJ 08628

PRINCIPAL DISPLAY PANEL - 18 Tablet Bottle Carton

SHORTENS COLDS

SUGAR-FREE
DYE-FREE

RAPIDMELTS®

Orange Cream
Flavor

18
Quick Dissolve
TABLETS

HOMEOPATHIC

INGREDIENTS AND APPEARANCE

ZICAM ULTRA COLD REMEDY RAPIDMELTS 
zinc acetate anhydrous and zinc gluconate tablet

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 10237-476
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	1 [hp_X]

Inactive Ingredients
Ingredient Name	Strength
CROSPOVIDONE (120 .MU.M) (UNII: 68401960MK)
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	WHITE	Score	no score
Shape	ROUND	Size	15mm
Flavor	CITRUS	Imprint Code	Z
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 10237-476-18	1 in 1 CARTON	02/18/2022
1		18 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		02/18/2022

Labeler - Church & Dwight Co., Inc. (001211952)

Establishment
Name	Address	ID/FEI	Business Operations
LNK International, Inc.		833150803	MANUFACTURE(10237-476)

Establishment
Name	Address	ID/FEI	Business Operations
LNK International, Inc.		967626305	MANUFACTURE(10237-476) , PACK(10237-476)

Establishment
Name	Address	ID/FEI	Business Operations
LNK International, Inc.		868734088	MANUFACTURE(10237-476) , PACK(10237-476)

Establishment
Name	Address	ID/FEI	Business Operations
LNK International, Inc.		038154464	MANUFACTURE(10237-476) , PACK(10237-476)

Establishment
Name	Address	ID/FEI	Business Operations
LNK International, Inc.		832867837	MANUFACTURE(10237-476) , PACK(10237-476)