Bronchial and Breathing Aide

Manufacturer
Schwabe North America, Inc | Schwabe Mexico SA DE CV
Effective date
2022-07-26
Label type
HUMAN OTC DRUG LABEL
Version
7
Source
full-release
Hydrated at
2026-06-01 02:17:53

Label at a glance#

ProductBronchial and Breathing Aide
Active ingredientACONITUM NAPELLUS, CALCIUM SULFIDE, SPONGIA OFFICINALIS SKELETON, ROASTED, Tin
Label structure12 sections

Label contents#

Full prescribing information#

Active Ingredients

OTC - ACTIVE INGREDIENT SECTION

Aconitum napellus 3X

Hepar sulphuris calcareum 12X 

Spongia tosta 3X

Stannum metallicum 12X

Inactive Ingredients

INACTIVE INGREDIENT SECTION

Cellulose

Lactose monohydrate

Magnesium stearate

Purpose

OTC - PURPOSE SECTION

Loosen phlegm (mucus),

thins bronchial secretions,

relieves bronchial congestion

Indications & Usage

INDICATIONS & USAGE SECTION

Loosen phlegm (mucus),

thins bronchial secretions,

relieves bronchial congestion

Dosage & Administration

DOSAGE & ADMINISTRATION SECTION

Sublingual mediation.

Place tablet under tonge at least 15 minutes before or 30 minutes after eating, brushing teeth or drinking anything except water.

Adults & Children 12 years of age and over: Take 2 tablets every 2 hours until relieved

Children under 12 years of age: Consult a doctor

Warning

WARNINGS SECTION

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 serious.

Consult a physician promptly.

Ask Doctor

OTC - ASK DOCTOR SECTION

Ask a doctor before use if you have a persistent or chronic cough that 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

Stop use and ask a doctor if new symptoms occur, symptoms worsen or do not get better within 7 days for adults or 5 days for children, 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 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 the reach of children.

Overdosage

OVERDOSAGE SECTION

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

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Bronchial_Breathing_Aide_21814098_04.jpgBronchial_Breathing_Aide_21814098_04.jpg

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
53499-9498-2Bronchial and Breathing Aide1 in 1 BOXTABLET17
53499-9498-2Bronchial and Breathing Aide100 in 1 BOTTLE, GLASSTABLET1007

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
53499-9498BRONCHIAL AND BREATHING AIDE (ACONITUM NAPELLUS, CALCIUM SULFIDE, SPONGIA OFFICINALIS SKELETON, ROASTED, TIN) TABLET [SCHWABE NORTH AMERICA, INC]7Current NDC, Legacy NDC, 2 package rows20220728_9cd140ec-8723-4635-8cec-646b61f0552e.zip

Products#

Every source-derived product name is available through these pages.

DailyMed product names page 1 of 1 · 9 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
53499-949853499-9498-2

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 7 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
Bronchial and Breathing AideACONITUM NAPELLUS, CALCIUM SULFIDE, SPONGIA OFFICINALIS SKELETON, ROASTED, TINSchwabe North America, Inc9cd140ec-8723-4635-8cec-646b61f0552e2022-07-26WarningsExact identifier
ndc (package): 53499-9498-2
ndc (product): 53499-9498
ndc11 (package): 53499949802
spl id: cacfe331-1c06-4471-8121-580d03a528a9
spl set id: 9cd140ec-8723-4635-8cec-646b61f0552e

Reported adverse events (FAERS/openFDA)#

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