Search by Drug Name or NDC

NDC 69676-0005-01 Cold Crush Childrens 12; 9; 6; 6; 12; 12; 6; 6; 9; 6 [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1 Details

Cold Crush Childrens 12; 9; 6; 6; 12; 12; 6; 6; 9; 6 [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1

Cold Crush Childrens is a ORAL TABLET, CHEWABLE in the HUMAN OTC DRUG category. It is labeled and distributed by Genexa Inc.. The primary component is ACONITUM NAPELLUS; BRYONIA ALBA ROOT; ECHINACEA ANGUSTIFOLIA; EUPHRASIA STRICTA; GELSEMIUM SEMPERVIRENS ROOT; IPECAC; MATRICARIA CHAMOMILLA WHOLE; ONION; PULSATILLA PRATENSIS; SAMBUCUS NIGRA FLOWER.

Product Information

NDC	69676-0005
Product ID	69676-0005_a7d2be02-c8c9-f36c-e053-2a95a90a0a82
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	Cold Crush Childrens
Proprietary Name Suffix	n/a
Non-Proprietary Name	Allium cepa, Belladonna, Bryonia alba, Chamomilla, Echinacea angustifolia, Euphrasia officinalis, Gelsemium sempervirens, Ipecacuanha, Pulsatilla, Sambucus nigra
Product Type	HUMAN OTC DRUG
Dosage Form	TABLET, CHEWABLE
Route	ORAL
Active Ingredient Strength	12; 9; 6; 6; 12; 12; 6; 6; 9; 6
Active Ingredient Units	[hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1
Substance Name	ACONITUM NAPELLUS; BRYONIA ALBA ROOT; ECHINACEA ANGUSTIFOLIA; EUPHRASIA STRICTA; GELSEMIUM SEMPERVIRENS ROOT; IPECAC; MATRICARIA CHAMOMILLA WHOLE; ONION; PULSATILLA PRATENSIS; SAMBUCUS NIGRA FLOWER
Labeler Name	Genexa Inc.
Pharmaceutical Class	Allergens [CS], Cell-mediated Immunity [PE], Dietary Proteins [CS], Increased Histamine Release [PE], Non-Standardized Food Allergenic Extract [EPC], Vegetable Proteins [CS]
DEA Schedule	n/a
Marketing Category	UNAPPROVED HOMEOPATHIC
Application Number	n/a
Listing Certified Through	2024-12-31

Package

Package Images

NDC 69676-0005-01 (69676000501)

Pricing Information	N/A
NDC Package Code	69676-0005-1
Billing NDC	69676000501
Package	1 BOTTLE, PLASTIC in 1 CARTON (69676-0005-1) / 60 TABLET, CHEWABLE in 1 BOTTLE, PLASTIC
Marketing Start Date	2018-07-03
NDC Exclude Flag	N

Standard Product Labeling (SPL)/Prescribing Information SPL 78ff02e4-7f3d-0ee9-e053-2a91aa0ad9bd Details

SPL UNCLASSIFIED SECTION

KEEP OUTER PACKAGE FOR COMPLETE PRODUCT INFORMATION

Drug Facts

SPL UNCLASSIFIED SECTION

Active ingredients‡** (in each tablet)

Aconitum napellus 12X HPUS

Allum cepa 6X HPUS

Bryonia alba 9X HPUS

Chamomilla 6X HPUS

Echinacea angustifolia 6X HPUS

Euphrasia officinalis 6X HPUS

Gelsemium sempervirens 12X HPUS

Ipecacuanha 12X HPUS

Pulsatilla 9X HPUS

Sambucus nigra 6X HPUS

‡ Certified Organic

"HPUS" indicates that this ingredient is officially included in the Homeopathic Pharmacopoeia of the United States.

SPL UNCLASSIFIED SECTION

Purpose

dry cough and wet cough

sneezing, runny nose and nasal discharge

sinus pain and stuffy nose

nasal congestion

sore throat and dry throat

chest congestion

headache and body aches

loss of smell

mucus and loss of taste

restless sleep

SPL UNCLASSIFIED SECTION

Uses*

addresses symptoms associated with the common cold, such as:

chest congestion
nasal congestion
runny nose
cough
sore throat
sneezing

SPL UNCLASSIFIED SECTION

Warnings

SPL UNCLASSIFIED SECTION

Stop use and ask a doctor if symptoms persist for more than 3 days or worsen.

SPL UNCLASSIFIED SECTION

Keep out of reach of children.

SPL UNCLASSIFIED SECTION

Directions

children 3-11 years of age:
chew 2 tablets at the onset of symptoms
do not swallow whole
repeat every 4-6 hours as needed
children under 3 years of age: ask a doctor before use

SPL UNCLASSIFIED SECTION

Other information

store between 15°-30°C (59°-86°F) in a dry place out of direct sunlight

SPL UNCLASSIFIED SECTION

Inactive ingredients

organic acai berry flavor, organic carnauba wax, organic dextrose, organic maltodextrin, organic rice bran extract

SPL UNCLASSIFIED SECTION

* CLAIMS BASED ON TRADITIONAL HOMEOPATHIC PRACTICE, NOT ACCEPTED MEDICAL EVIDENCE. NOT FDA EVALUATED.

** X is a homeopathic dilution: see www.genexa.com for more information.

Patent Pending

MADE IN THE USA WITH GLOBALLY SOURCED INGREDIENTS

SPL UNCLASSIFIED SECTION

THE Genexa® PLEDGE

WE PLEDGE TO DELIVER THE HIGHEST QUALITY MEDICINES.

All our products are made with clean, certified organic and non-GMO ingredients.

Genexa products maintain the highest standards in manufacturing and are made in the USA from globally sourced organic ingredients.

We pioneered the organic technology (patent pending) that eliminates harmful synthetics from our proprietary chewable tablet.

Our products are free of artificial dyes, flavors and preservatives.

Distributed by: Genexa Inc.

Beverly Hills, CA 90211

www.genexa.com

Certified Organic by SCS Global Services

SPL UNCLASSIFIED SECTION

BOTTLE IS SAFETY SEALED.

DO NOT USE IF BOTTLE SEAL IS DISTURBED OR MISSING.

SPL UNCLASSIFIED SECTION

Genexa®

THE HEALTHIER MEDICINE®

Genexa was founded on the belief that medicine should not only be UNQUESTIONABLY SAFE, but that it should be HEALTHY for you and your family.

We're also proud to be a Certified B Corporation using business as a force for good.

Questions? Comments?

1-855-GENEXA-1

[email protected]

PRINCIPAL DISPLAY PANEL

Children's

Genexa®

THE HEALTHIER MEDICINE®

NDC 69676-0005-1

Ages 3+

NON-DROWSY / ORGANIC & SAFE

COLD CRUSH®

COLD & COUGH*

Congestion & Mucus*
Cough & Sore Throat*
Runny Nose & Sneezing*

60 CHEWABLE TABLETS

HOMEOPATHIC

ORGANIC ACAI BERRY FLAVOR

USDA ORGANIC

NON GMO Project VERIFIED

INGREDIENTS AND APPEARANCE

COLD CRUSH CHILDRENS

allium cepa, belladonna, bryonia alba, chamomilla, echinacea angustifolia, euphrasia officinalis, gelsemium sempervirens, ipecacuanha, pulsatilla, sambucus nigra tablet, chewable

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:69676-0005
Route of Administration	ORAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
ONION (UNII: 492225Q21H) (ONION - UNII:492225Q21H)	ONION	6 [hp_X]
BRYONIA ALBA ROOT (UNII: T7J046YI2B) (BRYONIA ALBA ROOT - UNII:T7J046YI2B)	BRYONIA ALBA ROOT	9 [hp_X]
MATRICARIA CHAMOMILLA WHOLE (UNII: 2Z4LRR776S) (MATRICARIA CHAMOMILLA WHOLE - UNII:2Z4LRR776S)	MATRICARIA CHAMOMILLA WHOLE	6 [hp_X]
ECHINACEA ANGUSTIFOLIA (UNII: VB06AV5US8) (ECHINACEA ANGUSTIFOLIA - UNII:VB06AV5US8)	ECHINACEA ANGUSTIFOLIA	6 [hp_X]
EUPHRASIA STRICTA (UNII: C9642I91WL) (EUPHRASIA STRICTA - UNII:C9642I91WL)	EUPHRASIA STRICTA	6 [hp_X]
GELSEMIUM SEMPERVIRENS ROOT (UNII: 639KR60Q1Q) (GELSEMIUM SEMPERVIRENS ROOT - UNII:639KR60Q1Q)	GELSEMIUM SEMPERVIRENS ROOT	12 [hp_X]
IPECAC (UNII: 62I3C8233L) (IPECAC - UNII:62I3C8233L)	IPECAC	12 [hp_X]
PULSATILLA PRATENSIS (UNII: 8E272251DI) (PULSATILLA PRATENSIS - UNII:8E272251DI)	PULSATILLA PRATENSIS	9 [hp_X]
SAMBUCUS NIGRA FLOWER (UNII: 07V4DX094T) (SAMBUCUS NIGRA FLOWER - UNII:07V4DX094T)	SAMBUCUS NIGRA FLOWER	6 [hp_X]
ACONITUM NAPELLUS (UNII: U0NQ8555JD) (ACONITUM NAPELLUS - UNII:U0NQ8555JD)	ACONITUM NAPELLUS	12 [hp_X]

Ingredient Name	Strength
Inactive Ingredients
CARNAUBA WAX (UNII: R12CBM0EIZ)
MALTODEXTRIN (UNII: 7CVR7L4A2D)
RICE BRAN (UNII: R60QEP13IC)
DEXTROSE (UNII: IY9XDZ35W2)
ACAI (UNII: 46AM2VJ0AW)

Product Characteristics
Color	white (Off-white)	Score	no score
Shape	ROUND	Size	10mm
Flavor	BERRY	Imprint Code	G
Contains

#	Item Code	Package Description	Marketing Start Date
Packaging
1	NDC:69676-0005-1	1 in 1 CARTON	07/03/2018
1		60 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
unapproved homeopathic		07/03/2018

Labeler - Genexa Inc. (079751024)

Revised: 6/2020

Document Id: a7d2be02-c8c9-f36c-e053-2a95a90a0a82

Set id: 78ff02e4-7f3d-0ee9-e053-2a91aa0ad9bd

Version: 5

Effective Time: 20200611

Search by Drug Name or NDC

NDC 69676-0005-01 Cold Crush Childrens 12; 9; 6; 6; 12; 12; 6; 6; 9; 6 [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1 Details

Cold Crush Childrens 12; 9; 6; 6; 12; 12; 6; 6; 9; 6 [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1

Product Information

Package

Package Images

NDC 69676-0005-01 (69676000501)

Contents

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PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

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