BRONCHIAL AND BREATHING AIDE- aconitum napellus, calcium sulfide, spongia officinalis skeleton, roasted, tin tablet 
Schwabe Mexico S.A. de C.V

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.

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Bronchial and Breathing Aide

ACTIVE INGREDIENTS:

Aconitum napellus 3X

Hepar sulphuris calcareum (Calcium Sulfide) 12X

Spongia tosta 3X

Stannum metallicum (Tin) 12X

INACTIVE INGREDIENTS

Lactose monohydrate

Magnesium stearate

Microcrystalline cellulose

PURPOSE:

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

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.

NDICATIONS AND USAGE:

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

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:

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

Children:

Keep out of the reach of children.

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:

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

Bronchial_Breathing_Aide_21814098_04.jpgBronchial_Breathing_Aide_21814098_04.jpg

BRONCHIAL AND BREATHING AIDE 
aconitum napellus, calcium sulfide, spongia officinalis skeleton, roasted, tin tablet
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:68466-4098
Route of AdministrationSUBLINGUAL, SUBLINGUAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ACONITUM NAPELLUS (UNII: U0NQ8555JD) (ACONITUM NAPELLUS - UNII:U0NQ8555JD) ACONITUM NAPELLUS3 [hp_X]
CALCIUM SULFIDE (UNII: 1MBW07J51Q) (CALCIUM SULFIDE - UNII:1MBW07J51Q) CALCIUM SULFIDE12 [hp_X]
SPONGIA OFFICINALIS SKELETON, ROASTED (UNII: 1PIP394IID) (SPONGIA OFFICINALIS SKELETON, ROASTED - UNII:1PIP394IID) SPONGIA OFFICINALIS SKELETON, ROASTED3 [hp_X]
Tin (UNII: 387GMG9FH5) (TIN - UNII:387GMG9FH5) Tin12 [hp_X]
Inactive Ingredients
Ingredient NameStrength
LACTOSE MONOHYDRATE (UNII: EWQ57Q8I5X)  
MAGNESIUM STEARATE (UNII: 70097M6I30)  
CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)  
Product Characteristics
Colorwhite (B;T) Scoreno score
ShapeROUND (BT) Size8mm
FlavorImprint Code B;T
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:68466-4098-11 in 1 BOX04/01/2017
1100 in 1 BOTTLE, GLASS; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
unapproved homeopathic04/01/2017
Labeler - Schwabe Mexico S.A. de C.V (812805901)
Establishment
NameAddressID/FEIBusiness Operations
Schwabe Mexico S.A. de C.V.812805901manufacture(68466-4098)

Revised: 11/2019
Document Id: 3fc37db7-ee7b-4d41-a012-73f0bebf97e8
Set id: 96feb2ec-e051-4bb9-bd43-70ad103cef5a
Version: 3
Effective Time: 20191111
 
Schwabe Mexico S.A. de C.V