Cough and Bronchial Nighttime Syrup

Manufacturer
Schwabe Mexico S.A. DE C.V.
Effective date
2025-12-04
Label type
HUMAN OTC DRUG LABEL
Version
3
Source
full-release
Hydrated at
2026-06-01 02:35:38

Label at a glance#

ProductCough and Bronchial Nighttime Syrup
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 last 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 the reach of children

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Keep out of the 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 Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
e2db08c6-133f-4f4f-afb4-e90a2418d6f6Product name120230320
c6f86816-7da6-43ea-8c25-ac9758311cc5Product name120220118
3c386306-c48a-413e-bb69-70cb268496f3Product name120210727
ce6d5c06-3ae0-18a6-d5b3-8cd3cc0f8906Product name720210625
f52be47f-7aa7-46c0-b1fa-50c18dd50206Product name120201029
11ed6f83-cdd2-4637-8379-b1a1d3ae3cdeProduct name120181101
7792dadb-52b6-46b6-8fdf-80b1171065b5Product name120180810
86c45a79-b9f0-4476-a27c-6e10db098497Product name120180125
252e11b6-1a9a-4283-a242-df2c129c496dProduct name320170717
d5e51f11-ad28-caa4-4b49-4143974782adProduct name120150831

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
68466-1009-5Cough and Bronchial Nighttime Syrup120 mL in 1 BOTTLE, PLASTICSYRUP1203
68466-1009-5Cough and Bronchial Nighttime Syrup1 in 1 CARTONSYRUP13
68466-1009-9Cough and Bronchial Nighttime Syrup1 in 1 CARTONSYRUP13
68466-1009-9Cough and Bronchial Nighttime Syrup240 mL in 1 BOTTLE, PLASTICSYRUP2403

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
68466-100968466-1009-5, 68466-1009-9

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
Cough and Bronchial Nighttime SyrupACONITUM NAPELLUS, BRYONIA ROOT, CALCIUM CATION, SPONGIA OFFICINALIS SKELETON, ROASTED, TIN, MEDICAGO SATIVA LEAF, OAT, ARABICA COFFEE BEANSchwabe Mexico S.A. DE C.V.00d38f6f-dbab-4bbd-84b5-9807ea9073f82025-12-04WarningsExact identifier
ndc (package): 68466-1009-5
ndc (package): 68466-1009-9
ndc (product): 68466-1009
ndc11 (package): 68466100905
ndc11 (package): 68466100909
spl id: 07539805-19f1-4b88-9520-1d462925b215
spl set id: 00d38f6f-dbab-4bbd-84b5-9807ea9073f8

Reported adverse events (FAERS/openFDA)#

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