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

Bronchial and Breathing Aide by

Drug Labeling and Warnings

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

Drug Details [pdf]

ACTIVE INGREDIENT

ACTIVE INGREDIENTS:

Aconitum napellus 3X

Hepar sulphuris calcareum (Calcium Sulfide) 12X

Spongia tosta 3X

Stannum metallicum (Tin) 12X

INACTIVE INGREDIENT

INACTIVE INGREDIENTS

Lactose monohydrate

Magnesium stearate

Microcrystalline cellulose

PURPOSE

PURPOSE:

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

DOSAGE & ADMINISTRATION

Directions: Sublingual medication.

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

Adults and children 12 years of age and older: 2 tablets every two hours until relieved.

Children under 12 years of age: Consult a doctor.

INDICATIONS & USAGE

NDICATIONS AND USAGE:

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

WARNINGS

WARNINGS:

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.

PREGNANCY OR BREAST FEEDING

Pregnancy or Breast Feeding:

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

KEEP OUT OF REACH OF CHILDREN

Children:

Keep out of the reach of children.

ASK DOCTOR

Ask a doctor before use if you have :

a persisient or chronic cough that lasts, is chronic such as occurs with smoking, asthma, chronic bronchitis, or emplysema or is accompanied by excessive phlegm (mucus).

Stop use and ask a doctor if new symptons 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 a rash or persistent headache.

These could be signs of a serious condition.

OVERDOSAGE

Overdosage:

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

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

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: 68466-4098
Route of Administration	SUBLINGUAL, SUBLINGUAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
ACONITUM NAPELLUS (UNII: U0NQ8555JD) (ACONITUM NAPELLUS - UNII:U0NQ8555JD)	ACONITUM NAPELLUS	3 [hp_X]
CALCIUM SULFIDE (UNII: 1MBW07J51Q) (CALCIUM SULFIDE - UNII:1MBW07J51Q)	CALCIUM SULFIDE	12 [hp_X]
SPONGIA OFFICINALIS SKELETON, ROASTED (UNII: 1PIP394IID) (SPONGIA OFFICINALIS SKELETON, ROASTED - UNII:1PIP394IID)	SPONGIA OFFICINALIS SKELETON, ROASTED	3 [hp_X]
Tin (UNII: 387GMG9FH5) (TIN - UNII:387GMG9FH5)	Tin	12 [hp_X]

Inactive Ingredients
Ingredient Name	Strength
LACTOSE MONOHYDRATE (UNII: EWQ57Q8I5X)
MAGNESIUM STEARATE (UNII: 70097M6I30)
CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)

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	Marketing Start Date	Marketing End Date
1	NDC: 68466-4098-1	1 in 1 BOX	04/01/2017
1		100 in 1 BOTTLE, GLASS; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
unapproved homeopathic		04/01/2017

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(68466-4098)