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NDC 62750-0087-10 Zicam Cold Remedy Rapidmelts Elderberry Citrus 5; 2; 1 [hp_X]/1; [hp_X]/1; [hp_X]/1 Details

Zicam Cold Remedy Rapidmelts Elderberry Citrus 5; 2; 1 [hp_X]/1; [hp_X]/1; [hp_X]/1

Zicam Cold Remedy Rapidmelts Elderberry Citrus is a ORAL TABLET in the HUMAN OTC DRUG category. It is labeled and distributed by Matrixx Initiatives, Inc.. The primary component is SAMBUCUS NIGRA FLOWERING TOP; ZINC ACETATE ANHYDROUS; ZINC GLUCONATE.

Product Information

NDC	62750-0087
Product ID	62750-087_52dbf64e-e076-407b-86e9-1300efd9ea8d
Associated GPIs
GCN Sequence Number	n/a
GCN Sequence Number Description	n/a
HIC3	n/a
HIC3 Description	n/a
GCN	n/a
HICL Sequence Number	n/a
HICL Sequence Number Description	n/a
Brand/Generic	n/a
Proprietary Name	Zicam Cold Remedy Rapidmelts Elderberry Citrus
Proprietary Name Suffix	n/a
Non-Proprietary Name	Zinc Acetate Anhydrous, Zinc Gluconate, and Sambucus Nigra Flowering Top
Product Type	HUMAN OTC DRUG
Dosage Form	TABLET
Route	ORAL
Active Ingredient Strength	5; 2; 1
Active Ingredient Units	[hp_X]/1; [hp_X]/1; [hp_X]/1
Substance Name	SAMBUCUS NIGRA FLOWERING TOP; ZINC ACETATE ANHYDROUS; ZINC GLUCONATE
Labeler Name	Matrixx Initiatives, Inc.
Pharmaceutical Class	Copper Absorption Inhibitor [EPC], Copper Absorption Inhibitor [EPC], Decreased Copper Ion Absorption [PE], Decreased Copper Ion Absorption [PE]
DEA Schedule	n/a
Marketing Category	UNAPPROVED HOMEOPATHIC
Application Number	n/a
Listing Certified Through	n/a

Package

Package Images

NDC 62750-0087-10 (62750008710)

Pricing Information	N/A
NDC Package Code	62750-087-10
Billing NDC	62750008710
Package	1 BOTTLE in 1 CARTON (62750-087-10) / 25 TABLET in 1 BOTTLE
Marketing Start Date	2020-09-15
NDC Exclude Flag	N

Standard Product Labeling (SPL)/Prescribing Information SPL 7741b911-49e3-499f-8c50-1a5196a2300f Details

SPL UNCLASSIFIED SECTION

Drug Facts

SPL UNCLASSIFIED SECTION

Active ingredients (in each tablet)	Purpose
* Claims based on traditional homeopathic practice, not accepted medical evidence. Not FDA evaluated.
Zincum aceticum 2x Zincum gluconicum 1x	Reduces duration and severity of the common cold
Sambucus nigra (elderberry) 5x	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 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, D&C Red No. 27 aluminum lake, FD&C Blue No. 1 aluminum lake, magnesium stearate, mannitol, mono-ammonium glycyrrhizinate, natural and artificial flavor, sodium starch glycolate, stearic acid, sucralose

Questions? Comments? Side Effects?

call 877-942-2626 toll free

www.zicam.com

SPL UNCLASSIFIED SECTION

Distributed by Matrixx Initiatives, Inc.

Scottsdale, Arizona 85260

PRINCIPAL DISPLAY PANEL - 25 Tablet Bottle Carton

CLINICALLY PROVEN TO SHORTEN COLDS

NEW!

plus ELDERBERRY

RAPIDMELTS®

Elderberry Citrus Flavor

25

Quick Dissolve

TABLETS

HOMEOPATHIC

PRINCIPAL DISPLAY PANEL - 25 Tablet Bottle Carton

INGREDIENTS AND APPEARANCE

ZICAM COLD REMEDY RAPIDMELTS ELDERBERRY CITRUS

zinc acetate anhydrous, zinc gluconate, and sambucus nigra flowering top tablet

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:62750-087
Route of Administration	ORAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
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]
SAMBUCUS NIGRA FLOWERING TOP (UNII: CT03BSA18U) (SAMBUCUS NIGRA FLOWERING TOP - UNII:CT03BSA18U)	SAMBUCUS NIGRA FLOWERING TOP	5 [hp_X]

Ingredient Name	Strength
Inactive Ingredients
ASCORBIC ACID (UNII: PQ6CK8PD0R)
CROSPOVIDONE (120 .MU.M) (UNII: 68401960MK)
D&C RED NO. 27 ALUMINUM LAKE (UNII: ZK64F7XSTX)
FD&C BLUE NO. 1 ALUMINUM LAKE (UNII: J9EQA3S2JM)
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	PURPLE	Score	no score
Shape	ROUND	Size	15mm
Flavor	BERRY	Imprint Code	Z
Contains

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:62750-087-10	1 in 1 CARTON	09/15/2020	07/31/2023
1		25 in 1 BOTTLE; Type 0: Not a Combination Product

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
UNAPPROVED HOMEOPATHIC		09/15/2020	07/31/2023

Labeler - Matrixx Initiatives, Inc. (790037253)

Name	Address	ID/FEI	Business Operations
Establishment
LNK International, Inc.		833150803	MANUFACTURE(62750-087)

Name	Address	ID/FEI	Business Operations
Establishment
LNK International, Inc.		967626305	MANUFACTURE(62750-087) , PACK(62750-087)

Name	Address	ID/FEI	Business Operations
Establishment
LNK International, Inc.		868734088	MANUFACTURE(62750-087) , PACK(62750-087)

Name	Address	ID/FEI	Business Operations
Establishment
LNK International, Inc.		038154464	MANUFACTURE(62750-087) , PACK(62750-087)

Name	Address	ID/FEI	Business Operations
Establishment
LNK International, Inc.		832867837	MANUFACTURE(62750-087) , PACK(62750-087)

Revised: 1/2022

Document Id: 52dbf64e-e076-407b-86e9-1300efd9ea8d

Set id: 7741b911-49e3-499f-8c50-1a5196a2300f

Version: 2

Effective Time: 20220124

Search by Drug Name or NDC

NDC 62750-0087-10 Zicam Cold Remedy Rapidmelts Elderberry Citrus 5; 2; 1 [hp_X]/1; [hp_X]/1; [hp_X]/1 Details

Zicam Cold Remedy Rapidmelts Elderberry Citrus 5; 2; 1 [hp_X]/1; [hp_X]/1; [hp_X]/1

Product Information

Package

Package Images

NDC 62750-0087-10 (62750008710)

Contents

Standard Product Labeling (SPL)/Prescribing Information SPL 7741b911-49e3-499f-8c50-1a5196a2300f Details

SPL UNCLASSIFIED SECTION

SPL UNCLASSIFIED SECTION

Uses

Warnings

Directions

Other information

Inactive ingredients

Questions? Comments? Side Effects?

SPL UNCLASSIFIED SECTION

PRINCIPAL DISPLAY PANEL - 25 Tablet Bottle Carton

INGREDIENTS AND APPEARANCE

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