ZICAM COLD REMEDY RAPIDMELTS WITH ECHINACEA- zinc acetate anhydrous, echinacea angustifolia, and zinc gluconate tablet

Zicam by

Drug Labeling and Warnings

Zicam 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 INGREDIENT

Active ingredients (in each tablet)	Purpose
* Claims based on traditional homeopathic practice, not accepted medical evidence.; Not FDA evaluated.
Echinacea angustifolia 5x	Helps relieve stuffy nose*
Zincum aceticum 2x; Zincum gluconicum 1x	Reduces duration of the common cold and helps relieve nasal congestion

Uses

Reduces duration of the common cold and helps relieve nasal congestion

Zicam® 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

ascorbic acid, crospovidone, FD&C yellow no. 5 aluminum lake (tartrazine), flavor, magnesium stearate, mannitol, mono-ammonium glycyrrhizinate, sodium starch glycolate, stearic acid, sucralose

Questions? Comments?

call 877-942-2626 toll free

SPL UNCLASSIFIED SECTION

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

PRINCIPAL DISPLAY PANEL - 25 Tablet Bottle Carton

SHORTENS COLDS

ZINC
FORMULA!

RAPIDMELTS®

25
Quick Dissolve
TABLETS

Lemon-Lime Flavor

PLUS ECHINACEA

HOMEOPATHIC

INGREDIENTS AND APPEARANCE

ZICAM   COLD REMEDY RAPIDMELTS WITH ECHINACEA
zinc acetate anhydrous, echinacea angustifolia, and zinc gluconate tablet

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 10237-477
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]
ECHINACEA ANGUSTIFOLIA WHOLE (UNII: VB06AV5US8) (ECHINACEA ANGUSTIFOLIA WHOLE - UNII:VB06AV5US8)	ECHINACEA ANGUSTIFOLIA WHOLE	5 [hp_X]
ZINC GLUCONATE (UNII: U6WSN5SQ1Z) (ZINC CATION - UNII:13S1S8SF37)	ZINC GLUCONATE	1 [hp_X]

Inactive Ingredients
Ingredient Name	Strength
ascorbic acid (UNII: PQ6CK8PD0R)
CROSPOVIDONE (120 .MU.M) (UNII: 68401960MK)
FD&C Yellow No. 5 (UNII: I753WB2F1M)
aluminum oxide (UNII: LMI26O6933)
magnesium stearate (UNII: 70097M6I30)
mannitol (UNII: 3OWL53L36A)
ammonium glycyrrhizate (UNII: 3VRD35U26C)
stearic acid (UNII: 4ELV7Z65AP)
sucralose (UNII: 96K6UQ3ZD4)
sodium starch glycolate type a potato (UNII: 5856J3G2A2)

Product Characteristics
Color	YELLOW (light yellow)	Score	no score
Shape	ROUND (cup-shaped)	Size	15mm
Flavor	LEMON, LIME	Imprint Code	Z
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 10237-477-25	1 in 1 CARTON	08/26/2022
1		25 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		08/26/2022

Labeler - CHURCH & DWIGHT CO., INC. (001211952)

Establishment
Name	Address	ID/FEI	Business Operations
LNK International, Inc.		833150803	MANUFACTURE(10237-477)

Establishment
Name	Address	ID/FEI	Business Operations
LNK International, Inc.		967626305	MANUFACTURE(10237-477) , PACK(10237-477)

Establishment
Name	Address	ID/FEI	Business Operations
LNK International, Inc.		868734088	MANUFACTURE(10237-477) , PACK(10237-477)

Establishment
Name	Address	ID/FEI	Business Operations
LNK International, Inc.		038154464	MANUFACTURE(10237-477) , PACK(10237-477)

Establishment
Name	Address	ID/FEI	Business Operations
LNK International, Inc.		832867837	MANUFACTURE(10237-477) , PACK(10237-477)