NIGHTIME COUGH AND BRONCHIAL- aconitum napellus, bryonia alba root, calcium cation, spongia officinalis skeleton, roasted, tin, medicago sativa leaf, oat, arabica coffee bean syrup

Nightime Cough and Bronchial by

Drug Labeling and Warnings

Nightime Cough and Bronchial by is a Homeopathic medication manufactured, distributed, or labeled by Schwabe North America, Schwabe Mexico SA DE CV. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ACTIVE INGREDIENT

Broecke and Tafel Brand

Active Ingredients: 

Acontinum napellus 3X

Alfalfa 1X (medicago sativa leaf)

Coffea cruda 6X (arabica coffee bean)

Avena sativa 1X  (oat)

Bryonia Alba Root 3X

Hepar sulphuris calcareum 6C (calcium)

Spongia tosta 3X (spongia officinalis skeleton roasted)

Stannum metallicum 6C (tin)

Inactive Ingredients: Citrc Acid, Alcohol (10.5%), Malt Extract, Purified Water, Sodium Benzoate, Sucrose

Dosage and Administration Section

Recommendations:

Adults and children 12 years of age and older: 2 teaspoons (tsp) (10mL) 1/2 hour before bedtime.

Dosage may be repeated if necessary.

Children under 12: Ask a doctor.

WARNINGS

Warnings: 

Sore Throat Warning:  Severe or persistent sore throat for more than 2 days or if accompanied by a high fever, headache, nausea, vomiting or rash may be serious.

Consult a physician promptly. 

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).

Keep out of the reach of children

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

OVERDOSE:

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

INDICATIONS and USAGE SECTION

Temporarily relieves coughs due to minor throat and bronchial irritation occurring with a cold.

Helps loosen phlegm (mucus) and thin bronchial secretions to drain bronchial tubes.

Soothes the throat.

OTC PURPOSE SECTION

Temporarily relieves coughs due to minor throat and bronchial irritation occurring with a cold.

Helps loosen phlegm (mucus) and thin bronchial secretions to drain bronchial tubes.

Soothes the throat.

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

NIGHTIME COUGH AND BRONCHIAL 
aconitum napellus, bryonia alba root, calcium cation, spongia officinalis skeleton, roasted, tin, medicago sativa leaf, oat, arabica coffee bean syrup

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 53499-0693
Route of Administration	ORAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
ACONITUM NAPELLUS (UNII: U0NQ8555JD) (ACONITUM NAPELLUS - UNII:U0NQ8555JD)	ACONITUM NAPELLUS	3 [hp_X]  in 118 mL
BRYONIA ALBA ROOT (UNII: T7J046YI2B) (BRYONIA ALBA ROOT - UNII:T7J046YI2B)	BRYONIA ALBA ROOT	3 [hp_X]  in 118 mL
CALCIUM SULFIDE (UNII: 1MBW07J51Q) (CALCIUM SULFIDE - UNII:1MBW07J51Q)	CALCIUM SULFIDE	6 [hp_C]  in 118 mL
SPONGIA OFFICINALIS SKELETON, ROASTED (UNII: 1PIP394IID) (SPONGIA OFFICINALIS SKELETON, ROASTED - UNII:1PIP394IID)	SPONGIA OFFICINALIS SKELETON, ROASTED	3 [hp_X]  in 118 mL
TIN (UNII: 387GMG9FH5) (TIN - UNII:387GMG9FH5)	TIN	6 [hp_C]  in 118 mL
MEDICAGO SATIVA LEAF (UNII: HY3L927V6M) (MEDICAGO SATIVA LEAF - UNII:HY3L927V6M)	MEDICAGO SATIVA LEAF	1 [hp_X]  in 118 mL
OAT (UNII: Z6J799EAJK) (OAT - UNII:Z6J799EAJK)	OAT	1 [hp_X]  in 118 mL
ARABICA COFFEE BEAN (UNII: 3SW678MX72) (ARABICA COFFEE BEAN - UNII:3SW678MX72)	ARABICA COFFEE BEAN	6 [hp_X]  in 118 mL

Inactive Ingredients
Ingredient Name	Strength
ALCOHOL (UNII: 3K9958V90M)
ANHYDROUS CITRIC ACID (UNII: XF417D3PSL)
BARLEY MALT (UNII: R3NBG8914U)
WATER (UNII: 059QF0KO0R)
SODIUM BENZOATE (UNII: OJ245FE5EU)
SUCROSE (UNII: C151H8M554)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 53499-0693-5	1 in 1 CARTON	07/01/2004
1		118 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product
2	NDC: 53499-0693-9	1 in 1 CARTON	07/01/2004
2		237 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
unapproved homeopathic		07/01/2004

Labeler - Schwabe North America (831153908)

Establishment
Name	Address	ID/FEI	Business Operations
Schwabe Mexico SA DE CV		812805901	manufacture(53499-0693)