SPL v4
SPL
SPL Set ID 6869c5e4-d677-4598-b9b6-3d28f6c68eb5
Route
ORAL
Published
Effective Date 2011-03-14
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Aconitum Napellus (10 [hp_X]) Mephitis Mephitis Anal Gland Fluid Bromine Protortonia Cacti Corallium Rubrum Exoskeleton Copper Drosera Rotundifolia Calcium Sulfide Iodine Spongia Officinalis Skeleton, Roasted
Inactive Ingredients
Ascorbic Acid Guar Gum

Identifiers & Packaging

Marketing Status
UNAPPROVED HOMEOPATHIC Active Since 2011-03-14

Description

Acontium Napellus 10X, 30x, LM1 HPUS, Bromium 10X, 30x, LM1 HPUS, Coccus Cacti 10X, 30x, LM1 HPUS, Corallium Rubrum 10X, 30x, LM1 HPUS, Cuprum Metallicum 10X, 30x, LM1 HPUS, Drosera Rotundifolia 10X, 30x, LM1 HPUS, Hepar Sulphuris Calcareum 10X, 30x, LM1 HPUS, Iodium 10X, 30x, LM1 HPUS, Mephitis Mephitica 10X, 30x, LM1 HPUS, Spongia Tosta 10X, 30x, LM1 HPUS HPUS indicates that these ingredients are officially included in the Homeopathic Pharmacopoeia of the United States.

Purpose

Acontium Napellus..................Relieves dry croupy cough Bromium................................Relieves spasmodic attacks Coccus Cacti..........................Relieves tickling in throat Corallium Rubrum...................Relieves dry short barking cough Cuprum Metallicum................Relieves whooping cough Drosera Rotundifolia...............Relieves deep, hoarse cough Hepar Sulphuris Calcareum.....Relieves loose choking cough Iodium...................................Relieves raw, tickling throat Mephitis Mephitica.................Relieves night time cough attacks Spongia Tosta.......................Relieves deep chest cough


Medication Information

Purpose

Acontium Napellus..................Relieves dry croupy cough Bromium................................Relieves spasmodic attacks Coccus Cacti..........................Relieves tickling in throat Corallium Rubrum...................Relieves dry short barking cough Cuprum Metallicum................Relieves whooping cough Drosera Rotundifolia...............Relieves deep, hoarse cough Hepar Sulphuris Calcareum.....Relieves loose choking cough Iodium...................................Relieves raw, tickling throat Mephitis Mephitica.................Relieves night time cough attacks Spongia Tosta.......................Relieves deep chest cough

Description

Acontium Napellus 10X, 30x, LM1 HPUS, Bromium 10X, 30x, LM1 HPUS, Coccus Cacti 10X, 30x, LM1 HPUS, Corallium Rubrum 10X, 30x, LM1 HPUS, Cuprum Metallicum 10X, 30x, LM1 HPUS, Drosera Rotundifolia 10X, 30x, LM1 HPUS, Hepar Sulphuris Calcareum 10X, 30x, LM1 HPUS, Iodium 10X, 30x, LM1 HPUS, Mephitis Mephitica 10X, 30x, LM1 HPUS, Spongia Tosta 10X, 30x, LM1 HPUS HPUS indicates that these ingredients are officially included in the Homeopathic Pharmacopoeia of the United States.

Uses:

For temporary relief of dry, barking, spasmodic or croupy coughs due to the common cold or inhaled irritants.  Indications based on Homeopathic Materia Medica.

Section 50565-1


  • KEEP OUT OF THE REACH OF CHILDREN.

Section 51727-6


  • Buckwheat Honey, Purified Water, Ascorbic Acid (75mg of Vitamin C per serving), Guar Gum.

Section 51945-4






With 100% PURE Buckwheat Honey







Natural Medicine







4 fl. oz (118 mL)







Homeopathic Formulation (OTC)













Purpose:

Acontium Napellus..................Relieves dry croupy cough

Bromium................................Relieves spasmodic attacks

Coccus Cacti..........................Relieves tickling in throat

Corallium Rubrum...................Relieves dry short barking cough

Cuprum Metallicum................Relieves whooping cough

Drosera Rotundifolia...............Relieves deep, hoarse cough

Hepar Sulphuris Calcareum.....Relieves loose choking cough

Iodium...................................Relieves raw, tickling throat

Mephitis Mephitica.................Relieves night time cough attacks

Spongia Tosta.......................Relieves deep chest cough

Warnings:
  • Use only if protective seal is intact.  Do not feed honey to children under one year of age.  If cough persists for more than one week, tends to recur or is accompanied by fever, rash, or persistent headache, consult a physician.

Directions:

             Age                        Dose

     1 years to 5 years            1 teaspoon

     6 years to 11 years          1 1/2 teaspoons

     12 years to adult              2 teaspoons

Take every 2 to 4 hours until symptoms are relieved.

More Information:

If you have any questions or comments, or would like more information about Honey..Don't Cough or the complete line of HelloLife's natural OTC formulated medications, please visit our website at www.honeydontcough.com or www.hellolife.net. You can email us at [email protected] or give us a call toll-fee at 1.800.875.0850. We'd love to hear from you.



Manufactured for: HelloLife, LLC



Grand Rapids MI 49512



FDA Pharmaceutical Establishment

#1053442

www.honeydontcough.com



Made in the USA

Other Information:
  • Does not contain GMO, Gluten, alcohol, dye, preservatives, added sugar or artificial sweetners.
  • Safe for children 12 months and up
  • Store Honey..Don't Cough at room temperature

Active Ingredients:

Acontium Napellus 10X, 30x, LM1 HPUS, Bromium 10X, 30x, LM1 HPUS, Coccus Cacti 10X, 30x, LM1 HPUS, Corallium Rubrum 10X, 30x, LM1 HPUS, Cuprum Metallicum 10X, 30x, LM1 HPUS, Drosera Rotundifolia 10X, 30x, LM1 HPUS, Hepar Sulphuris Calcareum 10X, 30x, LM1 HPUS, Iodium 10X, 30x, LM1 HPUS, Mephitis Mephitica 10X, 30x, LM1 HPUS, Spongia Tosta 10X, 30x, LM1 HPUS

HPUS indicates that these ingredients are officially included in the Homeopathic Pharmacopoeia of the United States.


Structured Label Content

Uses:

For temporary relief of dry, barking, spasmodic or croupy coughs due to the common cold or inhaled irritants.  Indications based on Homeopathic Materia Medica.

Section 50565-1 (50565-1)


  • KEEP OUT OF THE REACH OF CHILDREN.

Section 51727-6 (51727-6)


  • Buckwheat Honey, Purified Water, Ascorbic Acid (75mg of Vitamin C per serving), Guar Gum.

Section 51945-4 (51945-4)






With 100% PURE Buckwheat Honey







Natural Medicine







4 fl. oz (118 mL)







Homeopathic Formulation (OTC)













Purpose:

Acontium Napellus..................Relieves dry croupy cough

Bromium................................Relieves spasmodic attacks

Coccus Cacti..........................Relieves tickling in throat

Corallium Rubrum...................Relieves dry short barking cough

Cuprum Metallicum................Relieves whooping cough

Drosera Rotundifolia...............Relieves deep, hoarse cough

Hepar Sulphuris Calcareum.....Relieves loose choking cough

Iodium...................................Relieves raw, tickling throat

Mephitis Mephitica.................Relieves night time cough attacks

Spongia Tosta.......................Relieves deep chest cough

Warnings:
  • Use only if protective seal is intact.  Do not feed honey to children under one year of age.  If cough persists for more than one week, tends to recur or is accompanied by fever, rash, or persistent headache, consult a physician.

Directions:

             Age                        Dose

     1 years to 5 years            1 teaspoon

     6 years to 11 years          1 1/2 teaspoons

     12 years to adult              2 teaspoons

Take every 2 to 4 hours until symptoms are relieved.

More Information:

If you have any questions or comments, or would like more information about Honey..Don't Cough or the complete line of HelloLife's natural OTC formulated medications, please visit our website at www.honeydontcough.com or www.hellolife.net. You can email us at [email protected] or give us a call toll-fee at 1.800.875.0850. We'd love to hear from you.



Manufactured for: HelloLife, LLC



Grand Rapids MI 49512



FDA Pharmaceutical Establishment

#1053442

www.honeydontcough.com



Made in the USA

Other Information:
  • Does not contain GMO, Gluten, alcohol, dye, preservatives, added sugar or artificial sweetners.
  • Safe for children 12 months and up
  • Store Honey..Don't Cough at room temperature

Active Ingredients:

Acontium Napellus 10X, 30x, LM1 HPUS, Bromium 10X, 30x, LM1 HPUS, Coccus Cacti 10X, 30x, LM1 HPUS, Corallium Rubrum 10X, 30x, LM1 HPUS, Cuprum Metallicum 10X, 30x, LM1 HPUS, Drosera Rotundifolia 10X, 30x, LM1 HPUS, Hepar Sulphuris Calcareum 10X, 30x, LM1 HPUS, Iodium 10X, 30x, LM1 HPUS, Mephitis Mephitica 10X, 30x, LM1 HPUS, Spongia Tosta 10X, 30x, LM1 HPUS

HPUS indicates that these ingredients are officially included in the Homeopathic Pharmacopoeia of the United States.


Advanced Ingredient Data


Raw Label Data

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