Childrens Cold Crush Tablet, Chewable
FDA Label NDC 69676-0073

Full FDA labeling including Indications, Dosage, Usage, and Precautions

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Genexa Inc. for the product Childrens Cold Crush (NDC 69676-0073). This document serves as the official prescribing information, containing essential scientific data and clinical materials required for healthcare providers and patients.

This specific version of the label includes detailed information regarding other, otc - active ingredient, otc - purpose, indications & usage, warnings, otc - stop use, otc - keep out of reach of children, dosage & administration, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Label Section Quick Index

→ Other

→ Otc - Active Ingredient

→ Otc - Purpose

→ Indications & Usage

→ Warnings

→ Otc - Stop Use

→ Otc - Keep Out Of Reach Of Children

→ Dosage & Administration

→ Storage And Handling

→ Inactive Ingredient

→ Otc - Questions

→ Package Label.principal Display Panel

Other

Drug Facts

‡ Organic

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

*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

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

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

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

Uses ^*

addresses symptoms associated with the common cold, such as:

chest congestion
cough
nasal congestion
sore throat
runny nose
sneezing

Warnings

Otc - Stop Use

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

Keep out of reach of children.

Dosage & Administration

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

Other information

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

Inactive Ingredient

Inactive ingredients

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

Otc - Questions

Questions?

1-855-436-3921

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-20220210 (1a Carton R 20220210)

* Please review the disclaimer below.

Previous Product 69676-0072

Next Product 69676-0074