FDA.reportPublic FDA data

Kids' Cold Crush

Manufacturer
Genexa Inc.
Effective date
2026-05-28
Label type
HUMAN OTC DRUG LABEL
Version
7
Source
daily-update
Hydrated at
2026-06-03 18:03:24

Label at a glance#

ProductGenexa Kids Cold Crush
Active ingredientONION, BRYONIA ALBA ROOT, MATRICARIA CHAMOMILLA WHOLE, ECHINACEA ANGUSTIFOLIA, EUPHRASIA STRICTA, GELSEMIUM SEMPERVIRENS ROOT, IPECAC, PULSATILLA PRATENSIS, SAMBUCUS NIGRA FLOWER, ACONITUM NAPELLUS
Label structure15 sections

Storage and handling

Other information store between 20-25°C (68-77°F) 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

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

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

INDICATIONS & USAGE SECTION

Uses*

addresses symptoms associated with the common cold, such as:

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

WARNINGS SECTION

Warnings

OTC - STOP USE SECTION

Stop use and ask a doctor if

  • difficulty breathing, vomiting, skin rash, diarrhea or fever above 100°F (38°C) 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 4-11 years of age

  • chew 2 tablets at the onset of symptoms
  • do not swallow whole
  • repeat every 4-6 hours as needed
children under 4 years of ageask a doctor before use

STORAGE AND HANDLING SECTION

Other information

store between 20-25°C (68-77°F) in a dry place out of direct sunlight

INACTIVE INGREDIENT SECTION

Inactive ingredients

carnauba wax (organic), dextrose (organic), açaÍ berry flavor (organic), maltodextrin (organic), rice bran extract (organic)

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/faq for more information.

SPL UNCLASSIFIED SECTION

Do not use if perforated band around the bottle or seal under the cap is broken or missing.

Distributed by: Genexa Inc.

Atlanta, GA 30324 genexa.com

Certified Organic by SCS Global Services

SPL UNCLASSIFIED SECTION

Made in the USA with globally sourced ingredients

NDC 69676-0049-1

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Genexa ®

CLEAN MEDICINE
Ages 4-11
Kids' Cold Crush ®

Homeopathic Cold & Cough Formula*
Congestion & Mucus*
Runny Nose & Sneezing*

Cough & Sore Throat*
0% Artificial Additives, Dyes, Artificial Sweeteners, Common Allergens
Made with Organic AçaÍ Berry Flavoring
Homeopathic
60 Chewable Tablets

1A carton_R-202603251A carton_R-20260325

DailyMed Product Concepts#

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

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
69676-0049-12025-02-20C16284748780-12cef2736-9937-d83d-e063-dadaa90ab31fKids' Cold Crush
69676-0049-12025-02-20C16284748780-12cef2736-9937-d83d-e063-dadaa90ab31fKids' Cold Crush
69676-0049-12025-01-30C16284748780-12cef2736-9937-d83d-e063-dadaa90ab31fKids' Cold Crush
69676-0049-12025-01-30C16284748780-12cef2736-9937-d83d-e063-dadaa90ab31fKids' Cold Crush

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
69676-004969676-0049-1

Ingredients#

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

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

Name, UNII, Kind table
NameUNIIKind
ONION492225Q21HACTIB
BRYONIA ALBA ROOTT7J046YI2BACTIB
MATRICARIA CHAMOMILLA WHOLE2Z4LRR776SACTIB
ECHINACEA ANGUSTIFOLIAVB06AV5US8ACTIB
EUPHRASIA STRICTAC9642I91WLACTIB
GELSEMIUM SEMPERVIRENS ROOT639KR60Q1QACTIB
IPECAC62I3C8233LACTIB
PULSATILLA PRATENSIS8E272251DIACTIB
SAMBUCUS NIGRA FLOWER07V4DX094TACTIB
CARNAUBA WAXR12CBM0EIZIACT
MALTODEXTRIN7CVR7L4A2DIACT
RICE BRANR60QEP13ICIACT
DEXTROSEIY9XDZ35W2IACT
ACONITUM NAPELLUSU0NQ8555JDACTIB
ACAI46AM2VJ0AWIACT

Source Document#

Source XML

Older Hydrated Versions#

Version, Effective date, Source table
VersionEffective dateSourceHydrated
62025-12-15full-release2026-06-01 02:35:53

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
Genexa Kids Cold CrushACONITUM NAPELLUS, ALLIUM CEPA, BRYONIA ALBA, CHAMOMILLA, ECHINACEA ANGUSTIFOLIA, EUPHRASIA OFFICINALIS, GELSEMIUM SEMPERVIRENS, IPECACUANHA, PULSATILLA, SAMBUCUS NIGRAGenexa Inc.ae095073-27d1-0aa5-e053-2a95a90a86d42026-05-28WarningsExact identifier
ndc (package): 69676-0049-1
ndc (product): 69676-0049
ndc11 (package): 69676004901
spl id: 52e9509c-b078-7fb0-e063-6294a90a350d
spl set id: ae095073-27d1-0aa5-e053-2a95a90a86d4

Reported adverse events (FAERS/openFDA)#

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