FDA.reportPublic FDA data

Bronkaid

Manufacturer
Foundation Consumer Healthcare LLC
Effective date
2024-03-14
Label type
HUMAN OTC DRUG LABEL
Version
2
Source
full-release
Hydrated at
2026-06-01 00:09:50

Label at a glance#

ProductBronkaid Max
Active ingredientEPHEDRINE SULFATE
Label structure11 sections

Indications and uses

for temporary relief of mild symptoms of intermittent asthma: wheezing tightness of chest shortness of breath

Dosage and administration

do not take more than directed adults and children 12 years and over: take 1 caplet every 4 hours as needed. Do not take more than 6 caplets in 24 hours or as directed by a doctor. children under 12 years of age: do not use

Storage and handling

store at 20-25°C (68-77°F)

Label contents#

Full prescribing information#

SPL UNCLASSIFIED SECTION

Drug Facts

Active ingredient (in each caplet)

OTC - ACTIVE INGREDIENT SECTION

Ephedrine sulfate 25 mg

Purpose

OTC - PURPOSE SECTION

Bronchodilator

Uses

INDICATIONS & USAGE SECTION

  • for temporary relief of mild symptoms of intermittent asthma:
  • wheezing
  • tightness of chest
  • shortness of breath

Warnings

WARNINGS SECTION

Asthma alert

SPL UNCLASSIFIED SECTION

Because asthma may be life threatening, see a doctor if you

  • are not better in 60 minutes
  • get worse
  • need more than 6 caplets in 24 hours
  • use more than 4 caplets in 24 hours for 3 or more days a week
  • have more than 2 asthma attacks in a week

These may be signs that your asthma is getting worse.

  • This product will not give you asthma relief as quickly as an inhaled bronchodilator.

Do not use

OTC - DO NOT USE SECTION

  • unless a doctor said you have asthma
  • if you are now 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 prescription drug contains an MAOI, ask a doctor or pharmacist before taking this product.
  • if you have ever had an allergic reaction to this product or any of its ingredients

Ask a doctor before use if you have

OTC - ASK DOCTOR SECTION

  • ever been hospitalized for asthma
  • heart disease
  • high blood pressure
  • diabetes
  • thyroid disease
  • seizures
  • narrow angle glaucoma
  • a psychiatric or emotional condition
  • trouble urinating due to an enlarged prostate gland

Ask a doctor or pharmacist before use if you are

OTC - ASK DOCTOR/PHARMACIST SECTION

  • taking prescription drugs for asthma, obesity, weight control, depression, or psychiatric or emotional conditions
  • taking any drug that contains phenylephrine, pseudoephedrine, ephedrine, or caffeine (such as for allergy, cough-cold, or pain)

When using this product

OTC - WHEN USING SECTION

  • your blood pressure or heart rate may go up. This could increase your risk of heart attack or stroke, which may cause death.
  • your risk of heart attack or stroke increases if you:
    • have a history of high blood pressure or heart disease
    • take this product more frequently or take more than the recommended dose
  • avoid foods or beverages that contain caffeine
  • avoid dietary supplements containing ingredients reported or claimed to have a stimulant effect

Stop use and ask a doctor if

OTC - STOP USE SECTION

  • your asthma is getting worse (see Asthma Alert)
  • you have difficulty sleeping
  • you have a rapid heart beat
  • you have tremors, nervousness, or seizure

OTC - PREGNANCY OR BREAST FEEDING SECTION

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

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

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

Directions

DOSAGE & ADMINISTRATION SECTION

  • do not take more than directed
  • adults and children 12 years and over: take 1 caplet every 4 hours as needed. Do not take more than 6 caplets in 24 hours or as directed by a doctor.
  • children under 12 years of age: do not use

Other information

STORAGE AND HANDLING SECTION

  • store at 20-25°C (68-77°F)

Inactive ingredients

INACTIVE INGREDIENT SECTION

dibasic calcium phosphate dihydrate, magnesium stearate, microcrystalline cellulose, polyethylene glycol, polyvinyl alcohol, silicon dioxide, sodium starch glycolate, stearic acid, talc

Questions or comments?

OTC - QUESTIONS SECTION

call 1-855-565-9800 weekdays 9 AM to 5 PM EST

SPL UNCLASSIFIED SECTION

Dist. by: Foundation Consumer Healthcare, LLC.
Pittsburgh, PA 15212

PRINCIPAL DISPLAY PANEL - 24 Caplet Blister Pack Carton

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

NDC 69536-250-24

BRONKAID® MAX

NEW FORMULA

Ephedrine Sulfate 25 mg/
Bronchodilator

STRONGEST FORMULA
available in a 1 caplet dose

✓ Restores
Free Breathing

Relief of Mild
Intermittent
Asthma Symptoms

PHARMACIST
RECOMMENDED BRAND

24
CAPLETS

PRINCIPAL DISPLAY PANEL - 24 Caplet Blister Pack Carton
PRINCIPAL DISPLAY PANEL - 24 Caplet Blister Pack Carton

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
2396449Bronkaid Max 25 MG Oral TabletPSN2
1116194ePHEDrine sulfate 25 MG Oral TabletPSN2
2396449ephedrine sulfate 25 MG Oral Tablet [Bronkaid Max]SBD2
1116194ephedrine sulfate 25 MG Oral TabletSCD2
2396449Bronkaid Max 25 MG Oral TabletSY2

DailyMed Pharmacologic Classes#

Class, Version, Type table
ClassVersionTypeEffective
EPHEDRINE Pharmacologic Class Indexing2Indexing - Pharmacologic Class20180813

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
d1bd959e-e326-44fb-b8ca-8c56a84a2a3dProduct name220251211
f1d178e1-1663-4c63-ae37-62a1b322fba4Product name220251106
f606d3ac-dd63-4b29-bea0-db23753b8ddcProduct name120220118
30254138-2d98-4aa2-8e07-ae82e8b0a389Product name320171103
fee762de-ffd9-404d-8bc6-8c0c208e758dProduct name120170426

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
69536-250-242024-03-14C16284748780-11030e365-4b5b-111a-e063-dadaa90a10e2Bronkaid ® Max
69536-250-602024-03-14C16284748780-11030e365-4b5b-111a-e063-dadaa90a10e2Bronkaid ® Max
69536-250-242024-01-30C16284748780-11030e365-4b5b-111a-e063-dadaa90a10e2Bronkaid ® Max
69536-250-602024-01-30C16284748780-11030e365-4b5b-111a-e063-dadaa90a10e2Bronkaid ® Max

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
69536-250-24Bronkaid Max6 in 1 BLISTER PACKTABLET, COATED62
69536-250-24Bronkaid Max4 in 1 CARTONTABLET, COATED42
69536-250-60Bronkaid Max12 in 1 BLISTER PACKTABLET, COATED122
69536-250-60Bronkaid Max5 in 1 CARTONTABLET, COATED52

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
69536-250BRONKAID MAX (EPHEDRINE SULFATE) TABLET, COATED [FOUNDATION CONSUMER HEALTHCARE LLC]2Current NDC, Legacy NDC, 4 package rows20240316_9a0b792a-caee-41f6-9400-922a5ebd592f.zip

Products#

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

DailyMed product names page 1 of 1 · 12 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
69536-25069536-250-24, 69536-250-60

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 10 matching rows.

Name, UNII, Kind table
NameUNIIKind
EPHEDRINE SULFATEU6X61U5ZEGACTIB
DIBASIC CALCIUM PHOSPHATE DIHYDRATEO7TSZ97GEPIACT
MAGNESIUM STEARATE70097M6I30IACT
MICROCRYSTALLINE CELLULOSEOP1R32D61UIACT
POLYETHYLENE GLYCOL, UNSPECIFIED3WJQ0SDW1AIACT
POLYVINYL ALCOHOL, UNSPECIFIED532B59J990IACT
SILICON DIOXIDEETJ7Z6XBU4IACT
SODIUM STARCH GLYCOLATE TYPE A POTATO5856J3G2A2IACT
STEARIC ACID4ELV7Z65APIACT
TALC7SEV7J4R1UIACT

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
Bronkaid MaxEPHEDRINE SULFATEFoundation Consumer Healthcare LLC9a0b792a-caee-41f6-9400-922a5ebd592f2024-03-14WarningsExact identifier
ndc (package): 69536-250-24
ndc (package): 69536-250-60
ndc (product): 69536-250
ndc11 (package): 69536025024
ndc11 (package): 69536025060
spl id: e406ff56-f8d4-49e8-b5ba-8c94bcf8052f
spl set id: 9a0b792a-caee-41f6-9400-922a5ebd592f

Reported adverse events (FAERS/openFDA)#

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