Bronchial and Breathing Aide: Homeopathic Product Information

BRONCHIAL AND BREATHING AIDE- aconitum napellus, calcium sulfide, spongia officinalis skeleton, roasted and tin tablet
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.

Active Ingredients

Aconitum napellus 3X

Hepar sulphuris calcareum (Calcium Sulfide) 12X

Spongia tosta 3X

Stannum metallicum (Tin) 12X

Inactive Ingredients

Cellulose

Lactose monohydrate

Magnesium stearate

Purpose

Helps loosen phlegm (mucus) and thins bronchial secretions, relieves bronchial congestion

Indications & Usage

Helps loosen phlegm (mucus) and thins bronchial secretions, relieves bronchial congestion.

Dosage & Administration

Directions: 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

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

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

Stope 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

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

Keep out of reach of children

Keep out of the reach of children.

Overdosage

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

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BRONCHIAL AND BREATHING AIDE
aconitum napellus, calcium sulfide, spongia officinalis skeleton, roasted, tin tablet
Product Information
Product Type HUMAN OTC DRUG Item Code (Source) NDC:53499-9498
Route of Administration SUBLINGUAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
ACONITUM NAPELLUS (ACONITUM NAPELLUS) ACONITUM NAPELLUS 3 [hp_X]
CALCIUM SULFIDE (CALCIUM SULFIDE) CALCIUM SULFIDE 12 [hp_X]
SPONGIA OFFICINALIS SKELETON, ROASTED (SPONGIA OFFICINALIS SKELETON, ROASTED) SPONGIA OFFICINALIS SKELETON, ROASTED 3 [hp_X]
Tin (TIN) Tin 12 [hp_X]
Inactive Ingredients
Ingredient Name Strength
LACTOSE MONOHYDRATE
MAGNESIUM STEARATE
CELLULOSE, MICROCRYSTALLINE
Product Characteristics
Color white (B;T) Score no score
Shape ROUND (BT) Size 8mm
Flavor Imprint Code B;T
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:53499-9498-2 1 BOTTLE, GLASS in 1 BOX contains a BOTTLE, GLASS
1 100 TABLET in 1 BOTTLE, GLASS This package is contained within the BOX (53499-9498-2)
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
unapproved homeopathic 04/01/2017
Labeler — Schwabe North America, Inc (831153908)
Establishment
Name Address ID/FEI Operations
Schwabe Mexico SA DE CV 812805901 manufacture (53499-9498)

Revised: 10/2020 Schwabe North America, Inc

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