Cough and Bronchial Childrens Syrup

Cough and Bronchial Childrens Syrup by

Drug Labeling and Warnings

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

Drug Details [pdf]

COUGH AND BRONCHIAL CHILDRENS SYRUP- antimony pentasulfide, bryonia alba root, drosera rotundifolia, eucalyptus globulus leaf, ipecac, illicium anisatum whole syrup 
Schwabe Mexico S.A. de C.V.

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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Cough and Bronchial Childrens Syrup

Active Ingredients

Antimonium sulphuratum aureum 6X

Bryonia 3X

Drosera 4X

Eucalyptus globulus 3X

Illicium verum 3X

Ipecacuanha 4X

Inactive Ingredients

Aronia Juice

Citric Acid

Ethyl Alcohol

Fructose

Natural flavor

Potassium Sorbate

Purified Water

Dosage & Administration

Shake well before use.

Children 6 to 12 Years: Take 2 teaspoons (tsp) (10mL) every 2 hours.

For severe coughs, repeat every 20 minutes for first hour, then every 2 hours.

Children under 6 years of age: Consult a doctor.

Purpose

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

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

Indications & Usage

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

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

Warning

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 Doctor

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

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.

Pregnant or Breast-feeding

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

Keep out of reach of children

Keep out of reach of children.

Overdosage

In case of overdosage, seek medical help or contact a Posion Control Center Immediately.

COUGH AND BRONCHIAL CHILDRENS SYRUP 
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: 68466-2010
Route of Administration	ORAL, 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 240 mL
BRYONIA ALBA ROOT (UNII: T7J046YI2B) (BRYONIA ALBA ROOT - UNII:T7J046YI2B)	BRYONIA ALBA ROOT	3 [hp_X]  in 240 mL
DROSERA ROTUNDIFOLIA FLOWERING TOP (UNII: 75O014T1HG) (DROSERA ROTUNDIFOLIA FLOWERING TOP - UNII:75O014T1HG)	DROSERA ROTUNDIFOLIA FLOWERING TOP	4 [hp_X]  in 240 mL
EUCALYPTUS GLOBULUS LEAF (UNII: S546YLW6E6) (EUCALYPTUS GLOBULUS LEAF - UNII:S546YLW6E6)	EUCALYPTUS GLOBULUS LEAF	3 [hp_X]  in 240 mL
IPECAC (UNII: 62I3C8233L) (IPECAC - UNII:62I3C8233L)	IPECAC	4 [hp_X]  in 240 mL
ILLICIUM VERUM WHOLE (UNII: 52JDS841PX) (ILLICIUM ANISATUM WHOLE - UNII:96MVO223I9)	ILLICIUM VERUM WHOLE	3 [hp_X]  in 240 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: 68466-2010-5	1 in 1 BOX	10/14/2021	03/31/2024
1		118 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product
2	NDC: 68466-2010-9	1 in 1 BOX	10/14/2021	03/31/2024
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		10/14/2021	03/31/2024

Labeler - Schwabe Mexico S.A. de C.V. (812805901)

Establishment
Name	Address	ID/FEI	Business Operations
Schwabe Mexico S.A. de C.V.		812805901	manufacture(68466-2010)

Revised: 5/2022

Document Id: bf4b13c0-c299-45a2-b503-8850e0f275d3

34390-5

Set id: 30011ddd-81b6-4f32-a5a9-bd936c135f8e

Version: 2

Effective Time: 20220525