CHILDRENS COUGH AND BRONCHIAL- antimony pentasulfide, bryonia alba root, drosera rotundifolia, eucalyptus globulus leaf, ipecac, illicium anisatum whole syrup

Childrens Cough and Bronchial by

Drug Labeling and Warnings

Childrens Cough and Bronchial by is a Homeopathic medication manufactured, distributed, or labeled by Schwabe North America, Inc, Schwabe Mexico S.A. de C.V.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ACTIVE INGREDIENT

Active Ingredients:  

Antimonium sulphuratum aureum 6X

Bryonia 3X

Drosera rotundifolia 4X

Eucalyptus globulus 3X

Illicium anisatum 3X

Ipecacuanha 4X

Inactive Ingredients:

Aronia Juice

Citric Acid

Ethyl Alcohol (1%)

Fructose

Natural flavor

Potassium Sorbate

Purified Water

DOSAGE & ADMINISTRATION

Dosage and Administration:

Shake well before use.

Children 6 to 12 Years:  two teaspoons (tsp) (10mL) every two hours.

For severe coughs, repeat every 20 minutes for first hour, then every two hours.

Children under 6 years of age:  Consult a doctor.

OTC Purpose: 

Temporarily relieves coughs due to minor throat and bronchial irritations as may occur with a cold.

Helps loosen phlegm (mucus) and thin bronchial secretions to drain bronchial tubes.

Indications and Usage:

Temporarily relieves coughs due to minor throat and bronchial irritations as may occur with a cold.
Helps loosen phlegm (mucus) and thin bronchial secretions to drain bronchial tubes.

Do not use: this product for children with persistent or chronic cough such as occurs with smoking, asthma, chronic bronchitis, or emphysema, or where cough is accompanied by excessive phlegm (mucus).

Ask a doctor before use if your child has a persistent or chronic cough that lasts, is chronic such as occurrs with smoking, asthma, chronic bronchitis, or emphysema, or is accompanied by excessive phlegm (mucus).

Stop use and ask a doctor if:

New symptoms occur, symptoms worsen, or do not get better within 7 days, if cough is accompanied by fever, rash or persistent headache. 

These could be signs of a serious conditions.

Keep Out of Reach of Children:

Keep out of reach of children.  

Overdose:

In case of overdose, seek medical help or contact a Poison Control Center immediately.

Pregnant of Breast-feeding:

If pregnant or breast-feeding, ask a healthcare porfessional before use.

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

CHILDRENS COUGH AND BRONCHIAL 
antimony pentasulfide, bryonia alba root, drosera rotundifolia, eucalyptus globulus leaf, ipecac, illicium anisatum whole syrup

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 53499-8393
Route of Administration	ORAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
ANTIMONY PENTASULFIDE (UNII: 1433F1I86N) (ANTIMONY PENTASULFIDE - UNII:1433F1I86N)	ANTIMONY PENTASULFIDE	6 [hp_X]  in 237 mL
BRYONIA ALBA ROOT (UNII: T7J046YI2B) (BRYONIA ALBA ROOT - UNII:T7J046YI2B)	BRYONIA ALBA ROOT	3 [hp_X]  in 237 mL
DROSERA ROTUNDIFOLIA FLOWERING TOP (UNII: 75O014T1HG) (DROSERA ROTUNDIFOLIA FLOWERING TOP - UNII:75O014T1HG)	DROSERA ROTUNDIFOLIA FLOWERING TOP	4 [hp_X]  in 237 mL
EUCALYPTUS GLOBULUS LEAF (UNII: S546YLW6E6) (EUCALYPTUS GLOBULUS LEAF - UNII:S546YLW6E6)	EUCALYPTUS GLOBULUS LEAF	3 [hp_X]  in 237 mL
IPECAC (UNII: 62I3C8233L) (IPECAC - UNII:62I3C8233L)	IPECAC	4 [hp_X]  in 237 mL
ILLICIUM ANISATUM WHOLE (UNII: 96MVO223I9) (ILLICIUM ANISATUM WHOLE - UNII:96MVO223I9)	ILLICIUM ANISATUM WHOLE	3 [hp_X]  in 237 mL

Inactive Ingredients
Ingredient Name	Strength
ARONIA MELANOCARPA FRUIT JUICE (UNII: D2EVP827PJ)
CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)
ALCOHOL (UNII: 3K9958V90M)
FRUCTOSE (UNII: 6YSS42VSEV)
POTASSIUM SORBATE (UNII: 1VPU26JZZ4)
WATER (UNII: 059QF0KO0R)

Product Characteristics
Color		Score
Shape		Size
Flavor	CHERRY (natural flavor)	Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 53499-8393-5	1 in 1 BOX	04/18/2017
1		118 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product
2	NDC: 53499-8393-9	1 in 1 BOX	04/18/2017
2		237 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
unapproved homeopathic		04/18/2017

Labeler - Schwabe North America, Inc (831153908)

Establishment
Name	Address	ID/FEI	Business Operations
Schwabe Mexico S.A. de C.V.		812805901	manufacture(53499-8393)