FDA.reportPublic FDA data

Primatene

Manufacturer
Foundation Consumer Brands
Effective date
2024-11-07
Label type
HUMAN OTC DRUG LABEL
Version
2
Source
full-release
Hydrated at
2026-06-01 00:35:21

Label at a glance#

ProductPrimatene
Active ingredientEPHEDRINE HYDROCHLORIDE
Label structure11 sections

Dosage and administration

do not take more than directed adults and children 12 years and over: take 1-2 tablets every 4 hours as needed. Do not take more than 12 tablets in 24 hours. 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 tablet)

OTC - ACTIVE INGREDIENT SECTION

Ephedrine HCl 12.5 mg

Purpose

OTC - PURPOSE SECTION

Bronchodilator

Use

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 12 tablets in 24 hours
  • use more than 8 tablets 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.

OTC - DO NOT USE SECTION

Do not use

  • unless a doctor said you have asthma
  • if you are now taking a prescription monoamine oxidase inhibitor (MAOI) (certain drugs taken 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

OTC - ASK DOCTOR SECTION

Ask a doctor before use if you have

  • 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

OTC - ASK DOCTOR/PHARMACIST SECTION

Ask a doctor or pharmacist before use if you are

  • 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)

OTC - WHEN USING SECTION

When using this product

  • 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

OTC - STOP USE SECTION

Stop use and ask a doctor if

  • 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 1-2 tablets every 4 hours as needed. Do not take more than 12 tablets in 24 hours.
  • 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

D&C yellow #10 aluminum lake, dibasic calcium phosphate dihydrate, FD&C yellow #6 aluminum lake, magnesium stearate, microcrystalline cellulose, silicon dioxide, sodium starch glycolate, stearic acid

Questions or comments?

OTC - QUESTIONS SECTION

Call 1-800-535-0026weekdays 9 AM to 5 PM EST

SPL UNCLASSIFIED SECTION

Distributed by:
Foundation Consumer Brands, LLC
Pittsburgh, PA 15212

PRINCIPAL DISPLAY PANEL - 12.5 mg Tablet Blister Pack Carton

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

NEW FORMULA

Primatene ®
TABLETS

Ephedrine HCl 12.5 mg • Bronchodilator

For the Temporary Relief of Mild Symptoms of
INTERMITTENT ASTHMA

24 TABLETS

PRINCIPAL DISPLAY PANEL - 12.5 mg Tablet Blister Pack Carton
PRINCIPAL DISPLAY PANEL - 12.5 mg Tablet Blister Pack Carton

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
2534871ePHEDrine HCl 12.5 MG Oral TabletPSN2
2591390Primatene with ePHEDrine 12.5 MG Oral TabletPSN2
2591390ephedrine hydrochloride 12.5 MG Oral Tablet [Primatene with ephedrine]SBD2
2534871ephedrine hydrochloride 12.5 MG Oral TabletSCD2
2534871ephedrine HCl 12.5 MG Oral TabletSY2
2591390Primatene with ephedrine 12.5 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

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
80070-600-24Primatene2 in 1 CARTONTABLET22
80070-600-24Primatene12 in 1 BLISTER PACKTABLET122
80070-600-60Primatene12 in 1 BLISTER PACKTABLET122
80070-600-60Primatene5 in 1 CARTONTABLET52

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
80070-600PRIMATENE (EPHEDRINE HYDROCHLORIDE) TABLET [FOUNDATION CONSUMER BRANDS]2Current NDC, Legacy NDC, 4 package rows20241109_2170f081-c03f-47e8-bc63-4052c5e653fa.zip

Products#

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

DailyMed product names page 1 of 1 · 11 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
80070-60080070-600-24, 80070-600-60

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 9 matching rows.

Name, UNII, Kind table
NameUNIIKind
SILICON DIOXIDEETJ7Z6XBU4IACT
DIBASIC CALCIUM PHOSPHATE DIHYDRATEO7TSZ97GEPIACT
D&C YELLOW NO. 10 ALUMINUM LAKECQ3XH3DET6IACT
FD&C YELLOW NO. 6H77VEI93A8IACT
MAGNESIUM STEARATE70097M6I30IACT
MICROCRYSTALLINE CELLULOSEOP1R32D61UIACT
SODIUM STARCH GLYCOLATE TYPE A POTATO5856J3G2A2IACT
STEARIC ACID4ELV7Z65APIACT
EPHEDRINE HYDROCHLORIDENLJ6390P1ZACTIB

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
PrimateneEPHEDRINE HYDROCHLORIDEFoundation Consumer Brands2170f081-c03f-47e8-bc63-4052c5e653fa2024-11-07WarningsExact identifier
ndc (package): 80070-600-60
ndc (package): 80070-600-24
ndc (product): 80070-600
ndc11 (package): 80070060024
ndc11 (package): 80070060060
spl id: 2657d074-46cb-bc95-e063-6294a90aeec8
spl set id: 2170f081-c03f-47e8-bc63-4052c5e653fa

Reported adverse events (FAERS/openFDA)#

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