Genexa Kids Cold Crush Tablet, Chewable
FDA Label NDC 69676-0049

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 Genexa Kids Cold Crush (NDC 69676-0049). 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

Keep outer package for complete product information

Drug Facts

* 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. DO NOT use if bottle seal is disturbed or missing.

Patent Pending | Distributed by:

Genexa Inc. Los Angeles, CA 90034

Certified Organic by SCS Global Services

Made in the USA with globally sourced ingredients

R-20200623

NDC 69676-0049-1

Otc - Active Ingredient

Active ingredients‡**

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

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
nasal congestion
runny nose
cough
sore throat
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 acai berry flavor, organic carnauba wax, organic maltodextrin, organic rice bran extract, organic tapioca dextrose

Otc - Questions

Questions?

1-855-436-3921

Mon.- Fri. 7am - 6pm PST

Package Label.Principal Display Panel

Genexa
REAL REMEDIES MADE CLEAN
Homeopathic Kids' Cold Crush
Congestion & Mucus*
Cough & Sore Throat*
Runny Nose & Sneezing*
Organic Cold & Cough*
Non-Drowsy
Flavored with Organic Acai Berry
No allergens, dyes or parabens
60 Chewable Tablets
Ages 3+

* Please review the disclaimer below.

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