FDA.reportPublic FDA data

Broncolito Children’s Honey (Apta)

Manufacturer
Pharmadel LLC
Effective date
2026-06-23
Label type
HUMAN OTC DRUG LABEL
Version
2
Source
weekly-update
Hydrated at
2026-07-17 21:41:48

Label at a glance#

ProductBroncolito Children
Active ingredientGUAIFENESIN, PHENYLEPHRINE HYDROCHLORIDE, DEXTROMETHORPHAN HYDROBROMIDE
Label structure10 sections

Indications and uses

Temporarily relieves common cold symptoms: stuffy nose nasal congestion cough due to minor throat and bronchial irritation helps loosen phlegm (mucus) and thin bronchial secretions to make coughs more productive

Dosage and administration

only use the dosage cup included do not exceed 6 doses in 24 hours Age Dose children 6 to under 12 years take 5 mL every 4 hours children 2 to under 6 years take 2.5 mL every 4 hours children under 2 years consult a doctor

Label contents#

Full prescribing information#

Drug Facts

SPL UNCLASSIFIED SECTION

.

Active ingredients & Purposes

OTC - ACTIVE INGREDIENT SECTION

.

OTC - PURPOSE SECTION

Active ingredients (in each 2.5 mL) Purposes

Dextromethorphan HBr 5 mg......................Cough suppressant

Guaifenesin 50 mg...............................................Expectorant

Phenylephrine HCI 2.5 mg........................Nasal decongestant

Uses

INDICATIONS & USAGE SECTION

Temporarily relieves common cold symptoms:

  • stuffy nose
  • nasal congestion
  • cough due to minor throat and bronchial irritation
  • helps loosen phlegm (mucus) and thin bronchial secretions to make coughs more productive

Warnings

WARNINGS SECTION

.

Do not use

OTC - DO NOT USE SECTION

  • in a child who is taking a prescription monoamine oxidase inhibitor (MAOI) (certain drugs for depression, psychiatric or emotional conditions, or Parkinson's disease), or for 2 weeks after stopping the MAOI drug. If you do not know if your child’s prescription drug contains an MAOI, ask a doctor or pharmacist before taking this product.

Ask a doctor before use if your child has

OTC - ASK DOCTOR SECTION

  • heart disease high blood pressure
  • thyroid disease
  • diabetes
  • a cough that is accompanied by excessive phlegm (mucus)
  • a persistent or chronic cough such as occurs with smoking, asthma

When using this product

OTC - WHEN USING SECTION

do not exceed recommended dosage

Stop use and ask a doctor if your child has

OTC - STOP USE SECTION

  • nervousness, dizziness, or sleeplessness occur
  • a persistent cough or symptoms do not improve within 7 days, tends to recur, or is accompanied by fever, rash, or persistent headache. These could be signs of a serious condition.

Keep out of reach of children.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

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

Directions

DOSAGE & ADMINISTRATION SECTION

  • only use the dosage cup included
  • do not exceed 6 doses in 24 hours
AgeDose
children 6 to under 12 yearstake 5 mL every 4 hours
children 2 to under 6 yearstake 2.5 mL every 4 hours
children under 2 yearsconsult a doctor

Other information

OTHER SAFETY INFORMATION

  • each 2.5 mL contains: sodium 1.5 mg
  • store between 68-77°F (20-25°C)

Inactive ingredients

INACTIVE INGREDIENT SECTION

anhydrous citric acid, FD&C yellow #6, flavor, glycerin, honey, propylene glycol, purified water, sodium benzoate, sorbitol solution, sucralose, xanthan gum

Questions?

OTC - QUESTIONS SECTION

+1-866-359-3478 (M-F) 9 AM - 5 PM EST or www.pharmadel.com

Dist by/ por:

SPL UNCLASSIFIED SECTION

PHARMADEL LLC

New Castle, DE 19720

Principal Display Panel

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

PDP BroncolitoPDP Broncolito

Products#

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

DailyMed product names page 1 of 1 · 17 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
55758-52055758-520-08

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
ANHYDROUS CITRIC ACIDXF417D3PSLIACT
HONEYY9H1V576FHIACT
SUCRALOSE96K6UQ3ZD4IACT
XANTHAN GUMTTV12P4NEEIACT
SORBITOL SOLUTION8KW3E207O2IACT
FD&C YELLOW NO. 6H77VEI93A8IACT
GLYCERINPDC6A3C0OXIACT
PROPYLENE GLYCOL6DC9Q167V3IACT
SODIUM BENZOATEOJ245FE5EUIACT
WATER059QF0KO0RIACT
GUAIFENESIN495W7451VQACTIB
PHENYLEPHRINE HYDROCHLORIDE04JA59TNSJACTIB
DEXTROMETHORPHAN HYDROBROMIDE9D2RTI9KYHACTIB

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
Broncolito ChildrenDEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, AND PHENYLEPHRINE HYDROCHLORIDEPharmadel LLC509f5b72-9894-ef44-e063-6394a90a6d072026-06-23WarningsExact identifier
ndc (package): 55758-520-08
ndc (product): 55758-520
ndc11 (package): 55758052008
spl id: 54ec4c3c-358a-2601-e063-6294a90afcf8
spl set id: 509f5b72-9894-ef44-e063-6394a90a6d07

Reported adverse events (FAERS/openFDA)#

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