Claritose
FDA Label NDC 49726-006

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

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Hello Life, Inc. for the product Claritose (NDC 49726-006). 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 active ingredients (per dose), purpose, uses, warnings, otc - ask doctor, otc - when using, otc - stop use, otc - pregnancy or breast feeding, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Active Ingredients (Per Dose)

Allium cepa HPUS
Ambrosia artemisiaefolia HPUS
Arsenicum album HPUS
Arundo mauritanica HPUS
Arum triphyllum HPUS
Euphrasia officinalis HPUS
Naphthalinum HPUS
Natrum muriaticum HPUS
Sabadilla HPUS
Wyethia helenioides HPUS



Each active ingredient contains equal volumes of 10X, 30X, and LM1 potencies. The letters “HPUS” indicate that the components in this product are officially monographed in the Homeopathic Pharmacopoeia of the United States. Product indications are based on Homeopathic Materia Medica.

Purpose

Allium cepa HPUS……………………………………………….Watery eyes
Ambrosia artemisiaefolia HPUS……………………………… Sneezing
Arsenicum album HPUS……………………………………….Wheezing
Arundo mauritanica HPUS……………………………………Cough
Arum triphyllum HPUS………………………………………...Hoarseness
Euphrasia officinalis HPUS..…………………………………Eye pressure
Naphthalinum HPUS…………………………………………..Hay Fever
Natrum muriaticum HPUS…………………………………….Difficult breathing
Sabadilla HPUS…………………………………………………Nasal discharge
Wyethia helenioides HPUS……………………………………Headache

Uses

for the temporary relief of symptoms commonly associated with allergies, such as:
•    watery eyes
•    coughing
•    sneezing
•    congestion

Indications based on Homeopathic Materia Medic for self-limiting conditions.

Warnings


Otc - Ask Doctor

Ask a doctor before use if

  • you are taking any other medications
  • you have a medical condition

Otc - When Using

When using this product, use only as directed.

Otc - Stop Use

Stop use and ask a doctor if symptoms persist or worsen.

Otc - Pregnancy Or Breast Feeding

If pregnant or breast-feeding, ask a health professional before use.

Otc - Keep Out Of Reach Of Children


Keep out of the reach of children.

Directions

Dispense Claritose directly into mouth, or add recommended dosage into 8-12 oz. of purified (non-chlorinated) water and drink. Safe for ages 2 and up.

Dosage By Weight

30-50 lbs                   1/2 mL
(13.6-22.6 kg)             twice per day

50+ lbs                      1 mL
(22.6+ kg)                  twice per day

Other Information


•    do not use if tamper seal is broken
•    store in a cool, dry place
•    product must not come in contact with metal
•    do not store next to electrical devices or appliances

Inactive Ingredients

citric acid, potassium sorbate, purified ionized mineral water.

Questions Or Comments?

You can email us at [email protected] or call us toll-free at
1.800.875.0850. Monday through Friday, 9am-5pm ET

Description

  • 30-day supply
  • dropper included
  • Claritose is made without alcohol or sugar. No gluten added.

  • Mftd for: HelloLife, Inc.
    4460 44th St. SE, Ste. C-600
    Grand Rapids, MI 49512
    FDA Pharmaceutical Establishment
    #1053442, #3009727070
    www.claritose.com

Principal Display Panel

NDC 49726-006-02

CLARITOSE®

Allergy Symptom Relief

For the temporary relief of symptoms commonly associated with allergies, such as:

  • watery eyes
  • coughing
  • sneezing
  • congestion
  • 2 fl oz (59 mL)
    Homeopathic (OTC) Medicine

    Claritosecarton (Claritosecarton)

    Claritosecarton (Claritosecarton)

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