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

Disclaimer: This drug has not been found by FDA to be safe and effective, and this labeling has not been approved by FDA. For further information about unapproved drugs, click here.

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Children's Cough and Bronchial Syrup

Active Ingredients

Antimonium sulphuratum aureum 6X

Bryonia 3X

Drosera 4X

Eucalyptus globulus 3X

Illicium anisatum 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: 2 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.

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 & 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.

Warnings

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

Ask Doctor

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

Stop Use

Stope use and ask a doctor if new symptoms occur, symptoms worsen or do not get better within 7 days. if couhg is acompanied by a fever, rash or persistent headache. These could be signs of a serious condition.

Pregnancy or Breast Feeding

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

Keep out of reach of children.

Overdose

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

21900393_C01 BT Children Cough Sryup.jpg

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

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
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

Ingredient Name	Strength
Inactive Ingredients
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

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:53499-8393-5	1 in 1 BOX	04/18/2017	03/31/2024
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	03/31/2024
2		237 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
unapproved drug other		04/18/2017	03/31/2024

Labeler - Schwabe North America, Inc (831153908)

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

Revised: 5/2022

Document Id: 3922f494-e1e9-4a08-96a2-89440ac163ae

Set id: 0509aa3a-027b-4226-a48a-9254b402aaad

Version: 8

Effective Time: 20220525

Schwabe North America, Inc