Cough and Bronchial: Homeopathic Product Information

COUGH AND BRONCHIAL- aconitum napellus, bryonia alba root, calcium sulfide, spongia officinalis skeleton, roasted and tin syrup
Schwabe North America

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 Ingredient

ACONITUM NAPELLUS 3X

BRYONIA 3X

HEPAR SULPHURIS CALCAREUM 6C

SPONGIA TOSTA 3X

STANNUM METALLICUM 6C

Inactive Ingredient

Citric acid

Ethyl Alcohol

Gum Arabic

Malt Extract

Purified Water

Sodium Benzoate

Sucrose

Dosage & Administration

Directions:

Shake well before each use.

Adults & children 12 years of age and older: Take 2 teaspoons (tsp) (10mL) every 2 hours. F or severe coughs, repeat every 20 minutes for first hour, then every 2 hours. Do not exceed 8 servings per day.

Children under 12 years of age: Consult a doctor.

Indications & Usage

Temporarily relieves cough due to minor throat and bronchial irritation as may occur with a cold.
Helps loosen phlegm (mucus) and thin bronchial secretions to drain bronchial tubes.
Soothes the throat.

Purpose

Temporarily relieves cough due to minor throat and bronchial irritation as may occur with a cold.
Helps loosen phlegm (mucus) and thin bronchial secretions to drain bronchial tubes.
Soothes the throat.

Warnings

Sore throat warning: if sore throat is severe, persists more than 2 days, is accompanied or followed by a fever, headache, rash, nausea, or vomiting, consult a doctor promptly.

Ask Doctor

Ask a doctor before use if you have a persistent or chronic cough such as occurs with smoking, asthma, chronic bronchitis, or emphysema, a cough that is accompanied by excessive phlegm (mucus), been taking any medications.

Stop Use

Stop use and ask a doctor if new symptons occur, symptoms get worse or last more than 7 days, fever worsens or lasts more than 3 days, cough lasts more than 7 days or occurs with rash or persisitent 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 reach of children

Overdose

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

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COUGH AND BRONCHIAL
aconitum napellus, bryonia alba root, calcium cation, spongia officinalis skeleton, roasted, tin syrup
Product Information
Product Type HUMAN OTC DRUG Item Code (Source) NDC:53499-1293
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
ACONITUM NAPELLUS (ACONITUM NAPELLUS) ACONITUM NAPELLUS 3 [hp_X] in 120 mL
BRYONIA ALBA ROOT (BRYONIA ALBA ROOT) BRYONIA ALBA ROOT 3 [hp_X] in 120 mL
CALCIUM SULFIDE (CALCIUM SULFIDE) CALCIUM SULFIDE 6 [hp_C] in 120 mL
SPONGIA OFFICINALIS SKELETON, ROASTED (SPONGIA OFFICINALIS SKELETON, ROASTED) SPONGIA OFFICINALIS SKELETON, ROASTED 3 [hp_X] in 120 mL
TIN (TIN) TIN 6 [hp_C] in 120 mL
Inactive Ingredients
Ingredient Name Strength
ACACIA
BARLEY MALT
WATER
SODIUM BENZOATE
SUCROSE
CITRIC ACID MONOHYDRATE
ALCOHOL
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:53499-1293-5 1 BOTTLE, PLASTIC in 1 CARTON contains a BOTTLE, PLASTIC
1 120 mL in 1 BOTTLE, PLASTIC This package is contained within the CARTON (53499-1293-5)
2 NDC:53499-1293-9 1 BOTTLE, PLASTIC in 1 CARTON contains a BOTTLE, PLASTIC
2 240 mL in 1 BOTTLE, PLASTIC This package is contained within the CARTON (53499-1293-9)
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
unapproved homeopathic 02/08/2023
Labeler — Schwabe North America (831153908)
Establishment
Name Address ID/FEI Operations
Schwabe Mexico, S.A. de C.V. 812805901 manufacture (53499-1293)

Revised: 09/2023 Schwabe North America

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