Respitrol
FDA Label NDC 49726-003

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 Respitrol (NDC 49726-003). 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 - when using, otc - stop use, otc - pregnancy or breast feeding, otc - keep out of reach of children, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Label Section Quick Index

Active Ingredients (Per Dose)

Ammonium carbonicum HPUS
Antimonium arsenicicum HPUS
Antimonium tartaricum HPUS
Arsenicum album HPUS
Bromium HPUS
Carbo vegetabilis HPUS
Chlorinum HPUS
Kali carbonicum HPUS
Lobelia inflata HPUS
Stannum metallicum HPUS
Sulphuricum acidum 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

Ammonium carbonicum HPUS………………….Burning in chest
Antimonium arsenicicum HPUS…………………Mucus congestion
Antimonium tartaricum HPUS……………………Cough
Arsenicum album HPUS………………………….Wheezing
Bromium HPUS……………………………………Asthma
Carbo vegetabilis HPUS……………………….…Wheezing respiration
Chlorinum HPUS…………………………………..Irritated bronchi
Kali carbonicum HPUS……………………………Cough
Lobelia inflata HPUS………………………………Shortness of breath
Stannum metallicum HPUS………………………Respiratory difficulty
Sulphuricum acidum HPUS………………………Bronchitis


Uses

to temporarily relieve minor symptoms commonly associated with asthma, such as:

  • tightness in chest           
  • cough
  • shortness of breath
  • wheezing

Warnings


Ask a doctor before use if

  • you are taking 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 Respitrol 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 Forms & Strengths


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
  • Respitrol is made without alcohol or sugar.  No gluten added.

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

Principal Display Panel

NDC 49726-003-02

RespitrolTM

Asthma Symptom Relief

To temporarily relieve minor symptoms commonly associated with asthma, such as:

  • tightness in chest
  • cough
  • shortness of breath
  • wheezing
    • 2 fl oz (59 mL)

    Homeopathic (OTC) Medicine

Respitrolcarton (Respitrolcarton)

Respitrolcarton (Respitrolcarton)

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