BRONCOLIN

Manufacturer
BRONCOLIN, S.A. de C.V.
Effective date
2022-10-14
Label type
HUMAN OTC DRUG LABEL
Version
2
Source
legacy-cache
Hydrated at
2026-08-01 21:51:34

Label at a glance#

ProductBRONCOLIN Honey Lemon
Active ingredientMENTHOL
Label structure11 sections

Indications and uses

temporarily relieves •Cough due to minor and bronchial irritation occurring with a cold or inhaled irritants •occasional minor irritation and sore throat

Dosage and administration

• adults and children 6 years and older: dissolve 1 drop slowly in the mouth. May be repeated every hour as needed or as directed by a doctor • children under 6 years: ask a doctor.

Label contents#

Full prescribing information#

Active Ingredient

OTC - ACTIVE INGREDIENT SECTION

Menthol 7.5mg

Purpose

OTC - PURPOSE SECTION

Cough Suppressant/Oral Anesthetic

Uses

INDICATIONS & USAGE SECTION

temporarily relieves •Cough due to minor and bronchial irritation occurring with a cold or inhaled irritants •occasional minor irritation and sore throat

Warnings

WARNINGS SECTION

Sore throat warning: If sore throat is severe •persists for more than 2 days • is accompanied or followed by fever, headache, rash, swelling, nausea, or vomiting, consult a doctor promptly. These symptoms may be serious.

Ask a doctor before use if you have

OTC - ASK DOCTOR SECTION

•persistent or chronic cough such as occurs with smoking, asthma, or emphysema •cough accompanied by excessive phlegm (mucus)

When using this product

OTC - WHEN USING SECTION

•do not exceed recommended dosage

Stop use and ask a doctor if

OTC - STOP USE SECTION

•cough persists for more than 7 days, tends to recur, or is accompanied by fever, rash, or persistent headache. These could be signs of a serious condition. •sore throat is severe or irritation, pain, or redness lasts or worsens •sore mouth does not improve in 7 days.

Keep out of reach of children

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

if pregnant or breast feeding ask a Health Professional before using

Directions

DOSAGE & ADMINISTRATION SECTION

• adults and children 6 years and older: dissolve 1 drop slowly in the mouth. May be repeated every hour as needed or as directed by a doctor • children under 6 years: ask a doctor.

Inactive Ingredients

INACTIVE INGREDIENT SECTION

Citric Acid, Elderberry flower extract, Eucalyptus leaf extract, Eucalyptus oil leaf extract, Glucose, Honey, Mullein flower extract, Sugar, artificial flavor, contains FD&C Yellow No. 5 (tartrazine) as a color additive and FD&C Blue No.1

Package Label

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Package LabelPackage Label

Products#

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NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
62583-01062583-010-22

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 11 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
1ce93198-902b-e4f5-e063-6294a90a32947ad0b87a-b797-9800-e053-2991aa0a7bdc2024-07-10WarningsExact identifier
spl set id: 7ad0b87a-b797-9800-e053-2991aa0a7bdc

Reported adverse events (FAERS/openFDA)#

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