Childrens Cold Crush
Children's Cold Crush
32ece9d6-b346-6304-e063-6394a90a182d
HUMAN OTC DRUG LABEL
Apr 16, 2025
Genexa Inc.
DUNS: 079751024
Products 1
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
Aconitum napellus, Allium cepa, Bryonia alba, Chamomilla, Echinacea angustifolia, Euphrasia officinalis, Gelsemium sempervirens, Ipecacuanha, Pulsatilla, Sambucus nigra
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
Product Classification
Product Specifications
INGREDIENTS (15)
Drug Labeling Information
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
INDICATIONS & USAGE SECTION
Uses*****
addresses symptoms associated with the common cold, such as:
- chest congestion
- cough
- nasal congestion
- sore throat
- runny nose
- sneezing
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
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
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
WARNINGS SECTION
Warnings
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
Keep out of reach of children.
DOSAGE & ADMINISTRATION SECTION
Directions
|
children 3-11 years of age |
|
|
children under 3 years of age |
ask a doctor before use |
STORAGE AND HANDLING SECTION
Other information
store between 20-25ºC (68-77ºF) in a dry place out of direct sunlight