Cold Crush Childrens

Manufacturer
Genexa LLC
Effective date
2019-10-19
Label type
HUMAN OTC DRUG LABEL
Version
4
Source
legacy-cache
Hydrated at
2026-08-02 00:06:43

Label at a glance#

ProductCold Crush Childrens
Active ingredientONION, ATROPA BELLADONNA WHOLE, BRYONIA ALBA ROOT, MATRICARIA CHAMOMILLA WHOLE, ECHINACEA ANGUSTIFOLIA, EUPHRASIA STRICTA, GELSEMIUM SEMPERVIRENS ROOT, IPECAC, PULSATILLA PRATENSIS, SAMBUCUS NIGRA FLOWER
Label structure16 sections

Storage and handling

Other information Store between 15°-30°C (59°-86°F) in a dry place out of direct sunlight.

Label 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)

Allum cepa 6X HPUS

Belladonna 12X 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

sneezing, runny nose and nasal discharge

dry cough and wet cough

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

*These "Uses" are based upon traditional homeopathic practice. They have not been reviewed by the Food and Drug Administration.

WARNINGS SECTION

Warnings

OTC - ASK DOCTOR SECTION

Ask a doctor before use in children under 3 years of age.

OTC - STOP USE SECTION

Stop use and ask a doctor if symptoms persist for more than 3 days or worsen.

OTC - PREGNANCY OR BREAST FEEDING SECTION

If pregnant or breastfeeding, ask a doctor before use.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Keep out of reach of children.

DOSAGE & ADMINISTRATION SECTION

Directions

  • For best results, use at the first sign of symptoms and continue to use as needed.
  • 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

THE Genexa® PLEDGE

WE PLEDGE TO DELIVER THE HIGHEST QUALITY MEDICINES.

All our medicines are made of pure, clean, Certified Organic and Non-GMO Ingredients, carefully sourced and rigorously managed.

Genexa medicines are regulated by the FDA as drugs. We maintain the highest standards in manufacturing.

We pioneered the organic technology that eliminates harmful synthetics from our proprietary chewable tablet. A first of its kind!

Our chewable medicines are free of lactose, gluten, artificial preservatives, flavorings and colors.

©2016 Distributed by:

Genexa LLC

Beverly Hills, CA 90212

www.genexahealth.com

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 EFFECTVE and 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@genexahealth.com

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Children's

Genexa®

#1 ORGANIC MEDICINE

NDC 69676-0051-1

Ages 3+

SAFE & EFFECTIVE / NON-DROWSY

COLD CRUSH®

ORGANIC COLD & COUGH*

  • Congestion & Mucus
  • Cough & Sore Throat
  • Runny Nose & Sneezing*

60 CHEWABLE TABLETS

HOMEOPATHIC

ORGANIC ACAI BERRY FLAVOR

USDA ORGANIC

NON GMO Project VERIFIED

29308_A2v229308_A2v2

Products#

Every source-derived product name is available through these pages.

DailyMed product names page 1 of 1 · 16 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
69676-005169676-0051-1

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 14 matching rows.

Source Document#

Source XML

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
95486538-af6a-5619-e053-2995a90adae92b82103f-3b2a-0b98-e054-00144ff88e882019-10-19WarningsExact identifier
spl id: 95486538-af6a-5619-e053-2995a90adae9
spl set id: 2b82103f-3b2a-0b98-e054-00144ff88e88

Reported adverse events (FAERS/openFDA)#

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