Childrens Cold Crush

Manufacturer
Genexa Inc.
Effective date
2025-04-16
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-06-01 02:33:38

Label at a glance#

ProductChildrens Cold Crush
Active ingredientBRYONIA ALBA ROOT, GELSEMIUM SEMPERVIRENS ROOT, ONION, MATRICARIA CHAMOMILLA WHOLE, ECHINACEA ANGUSTIFOLIA, EUPHRASIA STRICTA, SAMBUCUS NIGRA FLOWER, IPECAC, ACONITUM NAPELLUS, PULSATILLA PRATENSIS
Label structure13 sections

Storage and handling

Other information store between 20-25ºC (68-77ºF) in a dry place out of direct sunlight

Label contents#

Full prescribing information#

SPL UNCLASSIFIED SECTION

Drug Facts

OTC - ACTIVE INGREDIENT SECTION

Active Ingredients ‡**

Aconitum napellus 12X HPUS

Allium 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

OTC - PURPOSE 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

‡ Organic

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

INDICATIONS & USAGE SECTION

Uses *

addresses symptoms associated with the common cold, such as:

  • chest congestion
  • cough
  • nasal congestion
  • sore throat
  • runny nose
  • sneezing

WARNINGS SECTION

Warnings

OTC - STOP USE SECTION

Stop use and ask a doctor if

  • difficulty breathing, vomiting, skin rash, diarrhea or fever above 100º F (38ºC) develops
  • symptoms persist for more than 2 days or worsen

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Keep out of reach of children.

DOSAGE & ADMINISTRATION 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 ageask a doctor before use

STORAGE AND HANDLING SECTION

Other information

store between 20-25ºC (68-77ºF) in a dry place out of direct sunlight

INACTIVE INGREDIENT SECTION

Inactive ingredients

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

OTC - QUESTIONS SECTION

Questions?

1-855-436-3921

SPL UNCLASSIFIED SECTION

*CLAIMS BASED ON TRADITIONAL HOMEOPATHIC PRACTICE, NOT ACCEPTED MEDICAL EVIDENCE. NOT EVALUATED BY THE FOOD AND DRUG ADMINISTRATION.

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

SPL UNCLASSIFIED SECTION

Bottle is safety sealed with a perforated band around bottle. DO NOT use if bottle seal is disturbed or missing.

Patent Pending | Distributed by:

Genexa Inc. Atlanta, GA 30318

genexa.com

Certified Organic by SCS Global Services

Made in the USA with globally sourced ingredients

NDC 69676-0073-1

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Children's

Genexa ®

Ages 3-11

Cold Crush ®

Non-Drowsy Organic Cold & Cough*

Congestion & Mucus*

Cough & Sore Throat*

Runny Nose & Sneezing*

Know your ingredients

Made without: common allergens, artificial dyes or parabens

Homeopathic

60 Chewable Tablets

Organic Açaí Berry Flavor

1A_Carton_R-202202101A_Carton_R-20220210

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
ed912195-5da0-0f2f-6f4b-3ef17710cbe3Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
69676-0073-1Childrens Cold Crush1 in 1 CARTONTABLET, CHEWABLE11
69676-0073-1Childrens Cold Crush60 in 1 BOTTLE, PLASTICTABLET, CHEWABLE601

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
69676-0073CHILDRENS COLD CRUSH (ACONITUM NAPELLUS, ALLIUM CEPA, BRYONIA ALBA, CHAMOMILLA, ECHINACEA ANGUSTIFOLIA, EUPHRASIA OFFICINALIS, GELSEMIUM SEMPERVIRENS, IPECACUANHA, PULSATILLA, SAMBUCUS NIGRA) TABLET, CHEWABLE [GENEXA INC.]1Current NDC, 2 package rows20250523_32ece9d6-b346-6304-e063-6394a90a182d.zip

Products#

Every source-derived product name is available through these pages.

DailyMed product names page 1 of 1 · 17 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
69676-007369676-0073-1

Ingredients#

Every source-derived ingredient row is available through these pages.

DailyMed ingredient rows page 1 of 1 · 15 matching rows.

Source Document#

Source XML

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Childrens Cold CrushACONITUM NAPELLUS, ALLIUM CEPA, BRYONIA ALBA, CHAMOMILLA, ECHINACEA ANGUSTIFOLIA, EUPHRASIA OFFICINALIS, GELSEMIUM SEMPERVIRENS, IPECACUANHA, PULSATILLA, SAMBUCUS NIGRAGenexa Inc.32ece9d6-b346-6304-e063-6394a90a182d2025-04-16WarningsExact identifier
ndc (package): 69676-0073-1
ndc (product): 69676-0073
ndc11 (package): 69676007301
spl id: 32ece9d6-b347-6304-e063-6394a90a182d
spl set id: 32ece9d6-b346-6304-e063-6394a90a182d

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.