Nightime Cough and Bronchial

Manufacturer
Schwabe North America | Schwabe Mexico SA DE CV
Effective date
2025-12-04
Label type
HUMAN OTC DRUG LABEL
Version
4
Source
full-release
Hydrated at
2026-06-01 02:35:38

Label at a glance#

ProductNightime Cough and Bronchial
Active ingredientACONITUM NAPELLUS, BRYONIA ALBA ROOT, CALCIUM SULFIDE, SPONGIA OFFICINALIS SKELETON, ROASTED, TIN, MEDICAGO SATIVA LEAF, OAT, ARABICA COFFEE BEAN
Label structure12 sections

Label contents#

Full prescribing information#

Active Ingredient

OTC - ACTIVE INGREDIENT SECTION

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 INGREDIENT SECTION

citric acid

ethyl alcohol

malt extract

purified water

sodium benzoate

sucrose

Dosage & Administration

DOSAGE & ADMINISTRATION SECTION

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 

INDICATIONS & USAGE SECTION

Temporarily relieves coughs 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

OTC - PURPOSE SECTION

Temporarily relieves coughs 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

WARNINGS SECTION

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

OTC - ASK DOCTOR SECTION

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

OTC - STOP USE SECTION

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

OTC - PREGNANCY OR BREAST FEEDING SECTION

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

Keep out of reach of children

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Keep out of reach of children.

Overdose

OVERDOSAGE SECTION

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

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

LBN21900694_A08_BT_NIGHT_COUGH_8OZ_CTN_FNL.jpgLBN21900694_A08_BT_NIGHT_COUGH_8OZ_CTN_FNL.jpg

Product Linked Resources#

Resource, Code type, Value table
ResourceCode typeValueEquivalent identifiersSource image
BarcodeEAN-130308079006948GTIN-13: 0308079006948
EAN-13: 0308079006948
GTIN-12: 308079006948
UPC-A: 308079006948
GTIN storage (14 digits): 00308079006948
LBN21900694_A08_BT_NIGHT_COUGH_8OZ_CTN_FNL.jpg

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
53499-1693-5Nightime Cough and Bronchial1 in 1 CARTONSYRUP14
53499-1693-5Nightime Cough and Bronchial120 mL in 1 BOTTLE, PLASTICSYRUP1204
53499-1693-9Nightime Cough and Bronchial1 in 1 CARTONSYRUP14
53499-1693-9Nightime Cough and Bronchial240 mL in 1 BOTTLE, PLASTICSYRUP2404

Products#

Every source-derived product name is available through these pages.

DailyMed product names page 1 of 1 · 16 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
53499-169353499-1693-5, 53499-1693-9

Ingredients#

Every source-derived ingredient row is available through these pages.

DailyMed ingredient rows page 1 of 1 · 14 matching rows.

Source Document#

Source XML

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Nightime Cough and BronchialACONITUM NAPELLUS, BRYONIA ROOT, CALCIUM CATION, SPONGIA OFFICINALIS SKELETON, ROASTED, TIN, MEDICAGO SATIVA LEAF, OAT, ARABICA COFFEE BEANSchwabe North Americab3899e48-2db8-4deb-b976-eb143b6223dd2025-12-04WarningsExact identifier
ndc (package): 53499-1693-5
ndc (package): 53499-1693-9
ndc (product): 53499-1693
ndc11 (package): 53499169309
ndc11 (package): 53499169305
spl id: b1e89f9d-53fc-4469-b950-a341e3b43463
spl set id: b3899e48-2db8-4deb-b976-eb143b6223dd

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.