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

Cough and Bronchial Nighttime Syrup by

Drug Labeling and Warnings

Cough and Bronchial Nighttime Syrup by is a Homeopathic medication manufactured, distributed, or labeled by Schwabe Mexico S.A. DE C.V.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ACTIVE INGREDIENT

Broecke and Tafel Brand

Active Ingredients:

Acontinum napellus 3X

Alfalfa 1X 

Coffea cruda 6X 

Avena sativa 1X 

Bryonia 3X

Hepar sulphuris calcareum 6C 

Spongia tosta 3X 

Stannum metallicum 6C 

INACTIVE INGREDIENT

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

DOSAGE & ADMINISTRATION

Directions:

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 physician.

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 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.

PREGNANCY OR BREAST FEEDING

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

INDICATIONS & USAGE

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.

PURPOSE

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

COUGH AND BRONCHIAL NIGHTTIME SYRUP 
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: 68466-0009
Route of Administration	ORAL, 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: 68466-0009-5	1 in 1 CARTON	07/01/2004
1		120 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product
2	NDC: 68466-0009-9	1 in 1 CARTON	07/01/2004
2		240 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 Mexico S.A. DE C.V. (812805901)

Establishment
Name	Address	ID/FEI	Business Operations
Schwabe Mexico S.A. DE C.V.		812805901	manufacture(68466-0009)