Children's Cough and Bronchial Syrup

Manufacturer
Schwabe North America, Inc | Schwabe Mexico S.A. de C.V.
Effective date
2022-05-25
Label type
HUMAN OTC DRUG LABEL
Version
8
Source
legacy-cache
Hydrated at
2026-08-01 22:00:28

Label at a glance#

ProductChildrens Cough and Bronchial
Active ingredientANTIMONY PENTASULFIDE, BRYONIA ALBA ROOT, DROSERA ROTUNDIFOLIA FLOWERING TOP, EUCALYPTUS GLOBULUS LEAF, IPECAC, ILLICIUM ANISATUM WHOLE
Label structure9 sections

Label contents#

Full prescribing information#

Active Ingredients

OTC - ACTIVE INGREDIENT SECTION

Antimonium sulphuratum aureum 6X

Bryonia 3X

Drosera 4X

Eucalyptus globulus 3X

Illicium anisatum 3X

Ipecacuanha 4X

Inactive Ingredients

INACTIVE INGREDIENT SECTION

Aronia Juice

Citric Acid

Ethyl Alcohol

Fructose

Natural flavor

Potassium Sorbate

Purified Water

Dosage & Administration

DOSAGE & ADMINISTRATION SECTION

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

OTC - PURPOSE SECTION

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

INDICATIONS & USAGE SECTION

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

WARNINGS SECTION

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

OTC - ASK DOCTOR SECTION

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

OTC - STOP USE SECTION

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

OTC - PREGNANCY OR BREAST FEEDING SECTION

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

Keep out of reach of children.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Keep out of reach of children.

Overdose

OVERDOSAGE SECTION

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

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

21900393_C01 BT Children Cough Sryup.jpg21900393_C01 BT Children Cough Sryup.jpg

Products#

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NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
53499-839353499-8393-5, 53499-8393-9

Ingredients#

Every source-derived ingredient row is available through these pages.

DailyMed ingredient rows page 1 of 1 · 12 matching rows.

Source Document#

Source XML · Source PDF

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
3922f494-e1e9-4a08-96a2-89440ac163ae0509aa3a-027b-4226-a48a-9254b402aaad2022-05-25WarningsExact identifier
spl id: 3922f494-e1e9-4a08-96a2-89440ac163ae
spl set id: 0509aa3a-027b-4226-a48a-9254b402aaad

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.