FDA.reportPublic FDA data

Cough and Bronchial Daytime

Manufacturer
Schwabe North America, Inc.
Effective date
2026-05-14
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-06-01 02:38:36

Label at a glance#

ProductCough and Bronchial Daytime
Active ingredientACONITUM NAPELLUS, BRYONIA ALBA ROOT, CALCIUM SULFIDE, SPONGIA OFFICINALIS SKELETON, ROASTED, TIN
Label structure12 sections

Label contents#

Full prescribing information#

Active Ingredient

OTC - ACTIVE INGREDIENT SECTION

Aconitum napellus 3X

Bryonia 3X

Hepar sulphuris calcareum 6C

Spongia tosta 3X

Stannum metallicum 6C

Inactive Ingredients

INACTIVE INGREDIENT SECTION

Citric Acid

Ethyl Alcohol

Glycerin

Lactose Monohydrate

Oat Extract

Potassium Sorbate

Purified Water

Sorbitol

Dosage & Administration

DOSAGE & ADMINISTRATION SECTION

Directions:

Shake well before each use.

Adults & children 12 years of age and older: Take 2 teaspoons (tsp) (10mL) every 2 hours. For severe coughs, repeat every 20 minutes for first hour, then every 2 hours. Do not exceed 8 servings per day.

Children under 12 years of age: Consult a doctor.

Indications & Usage

INDICATIONS & USAGE SECTION

Temporarily relieves cough 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 cough 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 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 symptons 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 persisitent 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

LBN16251_B01_BT_DAY_COUGH_8oz_CTN_FNL.jpgLBN16251_B01_BT_DAY_COUGH_8oz_CTN_FNL.jpg

LN16251_B01_BT_DAY_COUGH_8oz_LBL_FNL.jpgLN16251_B01_BT_DAY_COUGH_8oz_LBL_FNL.jpg

LBN16252_B01_DAY_COUGH_4oz_CTN_FNL.jpgLBN16252_B01_DAY_COUGH_4oz_CTN_FNL.jpg

LN16252_B01_DAY_COUGH_4oz_LBL_FNL.jpgLN16252_B01_DAY_COUGH_4oz_LBL_FNL.jpg

Product Linked Resources#

Resource, Code type, Value table
ResourceCode typeValueEquivalent identifiersSource image
BarcodeEAN-130359800162518GTIN-13: 0359800162518
EAN-13: 0359800162518
GTIN-12: 359800162518
UPC-A: 359800162518
GTIN storage (14 digits): 00359800162518		LBN16251_B01_BT_DAY_COUGH_8oz_CTN_FNL.jpg
BarcodeEAN-130359800162525GTIN-13: 0359800162525
EAN-13: 0359800162525
GTIN-12: 359800162525
UPC-A: 359800162525
GTIN storage (14 digits): 00359800162525		LBN16252_B01_DAY_COUGH_4oz_CTN_FNL.jpg

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
53499-1625-4Cough and Bronchial Daytime1 in 1 CARTONSYRUP11
53499-1625-4Cough and Bronchial Daytime120 mL in 1 BOTTLE, PLASTICSYRUP1201
53499-1625-8Cough and Bronchial Daytime1 in 1 CARTONSYRUP11
53499-1625-8Cough and Bronchial Daytime240 mL in 1 BOTTLE, PLASTICSYRUP2401

Products#

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

DailyMed product names page 1 of 1 · 15 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
53499-162553499-1625-4, 53499-1625-8

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 13 matching rows.

Name, UNII, Kind table
NameUNIIKind
ACONITUM NAPELLUSU0NQ8555JDACTIB
CITRIC ACID MONOHYDRATE2968PHW8QPIACT
ALCOHOL3K9958V90MIACT
GLYCERINPDC6A3C0OXIACT
LACTOSE MONOHYDRATEEWQ57Q8I5XIACT
OATZ6J799EAJKIACT
POTASSIUM SORBATE1VPU26JZZ4IACT
WATER059QF0KO0RIACT
SORBITOL506T60A25RIACT
BRYONIA ALBA ROOTT7J046YI2BACTIB
CALCIUM SULFIDE1MBW07J51QACTIB
SPONGIA OFFICINALIS SKELETON, ROASTED1PIP394IIDACTIB
TIN387GMG9FH5ACTIB

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 DaytimeACONITUM NAPELLUS, BRYONIA ALBA ROOT, CALCIUM SULFIDE, SPONGIA OFFICINALIS SKELETON, ROASTED, TINSchwabe North America, Inc.ab0a4fd6-2311-4dd4-a146-949b86bfb4e72026-05-14WarningsExact identifier
ndc (package): 53499-1625-8
ndc (package): 53499-1625-4
ndc (product): 53499-1625
ndc11 (package): 53499162504
ndc11 (package): 53499162508
spl id: 495817a1-a080-46ea-a5fb-14ca9b261fe5
spl set id: ab0a4fd6-2311-4dd4-a146-949b86bfb4e7

Reported adverse events (FAERS/openFDA)#

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