Storage and handling
Other information store between 15°-30°C (59°-86°F) in a dry place out of direct sunlight
Cold Crush Childrens
- Manufacturer
- Genexa Inc.
- Effective date
- 2020-06-11
- Label type
- HUMAN OTC DRUG LABEL
- Version
- 5
- Source
- full-release
- Hydrated at
- 2026-06-01 02:13:12
Label at a glance#
ProductCold Crush Childrens
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
Contacts and useful links#
Websitewww.genexa.com
www.genexa.com
www.genexa.comLabel contents#
Full prescribing information#
SPL UNCLASSIFIED SECTION
KEEP OUTER PACKAGE FOR COMPLETE PRODUCT INFORMATION
Drug Facts
OTC - ACTIVE INGREDIENT 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.
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 symptoms persist for more than 3 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 age: ask a doctor before use
STORAGE AND HANDLING SECTION
Other information
store between 15°-30°C (59°-86°F) in a dry place out of direct sunlight
INACTIVE INGREDIENT 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
Certified Organic by SCS Global Services
OTHER SAFETY INFORMATION
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
hello@genexa.com
PACKAGE LABEL.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
DailyMed Product Concepts#
| Product concept | Relation | Version | Effective |
|---|---|---|---|
| ed912195-5da0-0f2f-6f4b-3ef17710cbe3 | Product name | 1 | 20140508 |
FDA-Initiated Inactive NDC Indexing#
| NDC | Effective | Action | Document | Indexing SPL | Related label |
|---|---|---|---|---|---|
| 69676-0005-1 | 2025-01-30 | C162847 | 48780-1 | 2cef2736-b675-d83d-e063-dadaa90ab31f | COLD CRUSH CHILDREN'S |
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 69676-0005-1 | Cold Crush Childrens | 1 in 1 CARTON | TABLET, CHEWABLE | 1 | 5 | |
| 69676-0005-1 | Cold Crush Childrens | 60 in 1 BOTTLE, PLASTIC | TABLET, CHEWABLE | 60 | 5 |
DailyMed Dashboard NDC Coverage#
| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|---|---|---|---|
| 69676-0005 | COLD CRUSH CHILDRENS (ALLIUM CEPA, BELLADONNA, BRYONIA ALBA, CHAMOMILLA, ECHINACEA ANGUSTIFOLIA, EUPHRASIA OFFICINALIS, GELSEMIUM SEMPERVIRENS, IPECACUANHA, PULSATILLA, SAMBUCUS NIGRA) TABLET, CHEWABLE [GENEXA INC.] | 5 | Legacy NDC, 2 package rows | 20200612_78ff02e4-7f3d-0ee9-e053-2a91aa0ad9bd.zip |
Products#
Every source-derived product name is available through these pages.
- Cold Crush Childrens
- Allium cepa, Belladonna, Bryonia alba, Chamomilla, Echinacea angustifolia, Euphrasia officinalis, Gelsemium sempervirens, Ipecacuanha, Pulsatilla, Sambucus nigra
- ONION
- BRYONIA ALBA ROOT
- MATRICARIA CHAMOMILLA WHOLE
- ECHINACEA ANGUSTIFOLIA
- EUPHRASIA STRICTA
- GELSEMIUM SEMPERVIRENS ROOT
- IPECAC
- PULSATILLA PRATENSIS
- SAMBUCUS NIGRA FLOWER
- CARNAUBA WAX
- MALTODEXTRIN
- RICE BRAN
- DEXTROSE
- ACONITUM NAPELLUS
- ACAI
NDC Codes#
| Product NDC | Package NDC |
|---|---|
| 69676-0005 | 69676-0005-1 |
Ingredients#
Every source-derived ingredient row is available through these pages.
| Name | UNII | Kind |
|---|---|---|
| ONION | 492225Q21H | ACTIB |
| BRYONIA ALBA ROOT | T7J046YI2B | ACTIB |
| MATRICARIA CHAMOMILLA WHOLE | 2Z4LRR776S | ACTIB |
| ECHINACEA ANGUSTIFOLIA | VB06AV5US8 | ACTIB |
| EUPHRASIA STRICTA | C9642I91WL | ACTIB |
| GELSEMIUM SEMPERVIRENS ROOT | 639KR60Q1Q | ACTIB |
| IPECAC | 62I3C8233L | ACTIB |
| PULSATILLA PRATENSIS | 8E272251DI | ACTIB |
| SAMBUCUS NIGRA FLOWER | 07V4DX094T | ACTIB |
| CARNAUBA WAX | R12CBM0EIZ | IACT |
| MALTODEXTRIN | 7CVR7L4A2D | IACT |
| RICE BRAN | R60QEP13IC | IACT |
| DEXTROSE | IY9XDZ35W2 | IACT |
| ACONITUM NAPELLUS | U0NQ8555JD | ACTIB |
| ACAI | 46AM2VJ0AW | IACT |
Source Document#
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.
| Brand | Generic | Manufacturer | SPL set ID | Effective date | Available safety fields | Join |
|---|---|---|---|---|---|---|
| a7d2be02-c8c9-f36c-e053-2a95a90a0a82 | 78ff02e4-7f3d-0ee9-e053-2a91aa0ad9bd | 2020-06-11 | Warnings | a7d2be02-c8c9-f36c-e053-2a95a90a0a82 78ff02e4-7f3d-0ee9-e053-2a91aa0ad9bd |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.