Drug Facts

Drug Facts
SPL v8
SPL
SPL Set ID b8ae66f1-6578-468b-a7c3-4ada7c41f250
Route
ORAL
Published
Effective Date 2016-01-19
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Carbonate Ion (10 [hp_X]) Arsenate Ion Antimony Cation (3+) Arsenic Cation (3+) Bromine Activated Charcoal Chlorine Lobelia Inflata Tin Sulfuric Acid
Inactive Ingredients
Water Potassium Sorbate Citric Acid Monohydrate

Identifiers & Packaging

Marketing Status
UNAPPROVED HOMEOPATHIC Active Since 2010-01-07

Description

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


Medication Information

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





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



Uses

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

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


Section 43678-2



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



Section 50565-1

Keep out of the reach of children.

Section 50566-9

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

Section 50567-7

When using this product, use only as directed.

Section 53414-9

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

Warnings



Ask a doctor before use if





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

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.


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



Principal Display Panel

NDC 49726-003-02

Respitrol TM

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

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.

Structured Label Content

Uses

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

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


Description (34089-3)


  • 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



Section 43678-2 (43678-2)



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



Section 50565-1 (50565-1)

Keep out of the reach of children.

Section 50566-9 (50566-9)

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

Section 50567-7 (50567-7)

When using this product, use only as directed.

Section 53414-9 (53414-9)

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

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





Warnings



Ask a doctor before use if





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

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.


Other Information (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 (Inactive ingredients)


citric acid, potassium sorbate, purified ionized mineral water


Questions Or Comments? (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



Principal Display Panel

NDC 49726-003-02

Respitrol TM

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

Active Ingredients (per Dose) (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.

Advanced Ingredient Data


Raw Label Data

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