Children's Cough and Bronchial Syrup

Drug Labeling and Warnings

Drug Details [pdf]

CHILDRENS COUGH AND BRONCHIAL- antimony pentasulfide, bryonia alba root, drosera rotundifolia, eucalyptus globulus leaf, ipecac, star anise syrup 
Schwabe North America, Inc

Disclaimer: This homeopathic product has not been evaluated by the Food and Drug Administration for safety or efficacy. FDA is not aware of scientific evidence to support homeopathy as effective.

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Children's Cough and Bronchial Syrup

Active Ingredients:  

Antimonium sulphuratum aureum 6X

Bryonia alba 3X

Drosera rotundifolia 3X

Eucalyptus globulus 3X

Illicium anisatum 3X

Ipecacuanha 4X

Inactive Ingredients:

Aronia Juice

Citric Acid

Ethyl Alcohol (1%)

Fructose

Natural cherry flavor

Potassium Sorbate

Purified Water

Dosage and Administration:

Shake Well Before Use

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

For severe coughs, repeat every 20 minutes for first hour, then every two hours.
Children under 6 uears pf age:  Ask a doctor.

OTC Purpose: 

Uses:  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.

Soothes the throat.

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.
Soothes the throat.

Sore Throat Warning

Severe or persistent sore throat for more than 2 days or if accompanied by high fever, headache, nausea, vomiting, or rash may be serioius.

Consult a physician promptly.

Ask a doctor before use if you have:

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, fever worsens or lasts more than 3 days, cough lasts more than 7 days or occurs with rash or persistent headache. 

These could be signs of a serious conditions.

Keep Out of Reach of Children:

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

Overdose:
In case of overdose, seek medical help or contract Poison Control Center immediately.

Pregnancy or Breastfeeding

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

Boericke & Tafel Children's Cough and Broncial Syrup (Cherry Flavored)

Package Label:

21900393  4 oz

21900594  8 oz

CHILDRENS COUGH AND BRONCHIAL 
antimony pentasulfide, bryonia alba root, drosera rotundifolia, eucalyptus globulus leaf, ipecac, star anise syrup

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 53499-0393
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	3 [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
STAR ANISE (UNII: XKC1657P78) (STAR ANISE - UNII:XKC1657P78)	STAR ANISE	1 [hp_X]  in 237 mL

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

Product Characteristics
Color		Score
Shape		Size
Flavor	CHERRY	Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 53499-0393-5	1 in 1 BOX	07/01/2004	04/30/2019
1		119 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product
2	NDC: 53499-0393-9	1 in 1 BOX	07/01/2004	09/30/2018
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		07/01/2004	04/30/2019

Labeler - Schwabe North America, Inc (831153908)

Establishment
Name	Address	ID/FEI	Business Operations
Schwabe Mexico S.A. de C.V.		812805901	manufacture(53499-0393)

Revised: 4/2017

Document Id: 1a594124-05d4-43e6-a5c1-c7d7d51dcf1d

34390-5

Set id: 8881f74f-7a04-4cca-ad1b-52fdb85f6825

Version: 6

Effective Time: 20170414