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

----------

Nighttime Cough and Bronchial

Active Ingredient

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

citric acid

ethyl alcohol

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) 1/2 hour before bedtime. Dose may be repeated if necessary.

Children under 12 years of age: Consult a doctor

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.

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 a 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 symptoms 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 persistent 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.

LBN21900694_A08_BT_NIGHT_COUGH_8OZ_CTN_FNL.jpg

Add image transcription here...

NIGHTIME COUGH AND BRONCHIAL 
aconitum napellus, bryonia root, calcium cation, spongia officinalis skeleton, roasted, tin, medicago sativa leaf, oat, arabica coffee bean syrup
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:53499-1693
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ACONITUM NAPELLUS (UNII: U0NQ8555JD) (ACONITUM NAPELLUS - UNII:U0NQ8555JD) ACONITUM NAPELLUS3 [hp_X]  in 120 mL
BRYONIA ALBA ROOT (UNII: T7J046YI2B) (BRYONIA ALBA ROOT - UNII:T7J046YI2B) BRYONIA ALBA ROOT3 [hp_X]  in 120 mL
CALCIUM SULFIDE (UNII: 1MBW07J51Q) (CALCIUM SULFIDE - UNII:1MBW07J51Q) CALCIUM SULFIDE6 [hp_C]  in 120 mL
SPONGIA OFFICINALIS SKELETON, ROASTED (UNII: 1PIP394IID) (SPONGIA OFFICINALIS SKELETON, ROASTED - UNII:1PIP394IID) SPONGIA OFFICINALIS SKELETON, ROASTED3 [hp_X]  in 120 mL
TIN (UNII: 387GMG9FH5) (TIN - UNII:387GMG9FH5) TIN6 [hp_C]  in 120 mL
MEDICAGO SATIVA LEAF (UNII: HY3L927V6M) (MEDICAGO SATIVA LEAF - UNII:HY3L927V6M) MEDICAGO SATIVA LEAF1 [hp_X]  in 120 mL
OAT (UNII: Z6J799EAJK) (OAT - UNII:Z6J799EAJK) OAT1 [hp_X]  in 120 mL
ARABICA COFFEE BEAN (UNII: 3SW678MX72) (ARABICA COFFEE BEAN - UNII:3SW678MX72) ARABICA COFFEE BEAN6 [hp_X]  in 120 mL
Inactive Ingredients
Ingredient NameStrength
ALCOHOL (UNII: 3K9958V90M)  
ANHYDROUS CITRIC ACID (UNII: XF417D3PSL)  
BARLEY MALT (UNII: R3NBG8914U)  
WATER (UNII: 059QF0KO0R)  
SODIUM BENZOATE (UNII: OJ245FE5EU)  
SUCROSE (UNII: C151H8M554)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:53499-1693-51 in 1 CARTON03/03/2023
1120 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product
2NDC:53499-1693-91 in 1 CARTON03/03/2023
2240 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
unapproved homeopathic03/03/2023
Labeler - Schwabe North America (831153908)
Establishment
NameAddressID/FEIBusiness Operations
Schwabe Mexico SA DE CV812805901manufacture(53499-1693)

Revised: 3/2023
Document Id: aea5fbda-1590-41ee-8f7d-ab074e462d18
Set id: b3899e48-2db8-4deb-b976-eb143b6223dd
Version: 1
Effective Time: 20230303
 
Schwabe North America