Ephed Asthma

Manufacturer
Dickey Consumer Products DBA DMD | Ultratab Laboratories, Inc. | Ultra Seal Corp.
Effective date
2019-03-28
Label type
HUMAN OTC DRUG LABEL
Version
3
Source
full-release
Hydrated at
2026-05-31 22:59:02

Label at a glance#

ProductEphed Asthma
Active ingredientEPHEDRINE HYDROCHLORIDE, GUAIFENESIN
Label structure9 sections

Label contents#

Full prescribing information#

OTC - ACTIVE INGREDIENT SECTION

Active Ingredient(In Each Tablet): Ephedrine HCl 25 mg, Guaifenesin 200 mg

OTC - PURPOSE SECTION

Purposes - Bronchodilator, Expectorant

INDICATIONS & USAGE SECTION

• for temporary relief of mild symptoms of intermittent asthma: • wheezing • tightness of chest • shortness of breath. Helps loosen phlegm (mucus) and thin bronchial secretions to rid bronchial passageways of bothersome mucus, and to make coughs more productive.

WARNINGS SECTION

Asthma Alert:  because asthma may be life threatening, see a doctor if you: • Are not better in 60 minutes • get worse • need more than 6 tablets in 24 hours • use more than 4 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 relief as quickly as an inhaled bronchodilator

Do not use: • 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.

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 • cough that occurs with too much phlegm (mucus) • cough that lasts or is chronic such as occurs with smoking, asthma, chronic bronchitis, or emphysema.

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)

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 food or beverages that contain caffeine • Avoid dietary supplements containing ingredients reported or claim to have a stimulant effect.  

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 seizures • cough lasts more than 1 week, comes back , or occurs with fever, rash, or persistent headache.  These could be signs of a serious condition.

OTC - PREGNANCY OR BREAST FEEDING SECTION

If pregnant or breast feeding, ask a health proffessional 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.

DOSAGE & ADMINISTRATION SECTION

• do not take more than directed • adults and children 12 years of age and over: 1 tablet every 4 hours as needed, do not take more than 6 tablets in 24 hours • children under 12 years of age: do not use

INACTIVE INGREDIENT SECTION

Inactive Ingredients: Maltodextrin, Microcrystalline Cellulose, Povidone, Sodium Starch Glycolate,Stearic Acid

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Ephed Plus EP225 24ctEphed Plus EP225 24ctEphed Plus EP225 24ctEphed Plus EP225 24ctEphed Plus EP225 24ctEphed Plus EP225 24ctEphed Plus EP225 24ctEphed Plus EP225 24ct

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
1116145ePHEDrine HCl 25 MG / guaiFENesin 200 MG Oral TabletPSN3
1116145ephedrine hydrochloride 25 MG / guaifenesin 200 MG Oral TabletSCD3

DailyMed Pharmacologic Classes#

Class, Version, Type table
ClassVersionTypeEffective
EPHEDRINE Pharmacologic Class Indexing2Indexing - Pharmacologic Class20180813
GUAIFENESIN Pharmacologic Class Indexing1Indexing - Pharmacologic Class20211129

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
4fe95224-f543-4dbb-9445-8cca122b48c8Product name120150609
e8718272-64cb-4436-969b-176c3067c8f4Product name120150609
106ff02a-57e1-4c4c-a307-fd582ff4e311Product name120150212

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
65193-320-242023-01-30C16284748780-1f386c64a-4268-0266-e053-dadaa90a7c1aDRUG FACTS

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
65193-320-24Ephed Asthma24 in 1 BLISTER PACKTABLET243

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
65193-320EPHED ASTHMA (EPHEDRINE HYDROCHLORIDE, GUAIFENESIN) TABLET [DICKEY CONSUMER PRODUCTS DBA DMD]3Legacy NDC, 1 package rows20190402_172e970d-6773-4796-a280-3370e2f46c69.zip

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIISPL versionUploaded
EPHEDRINE HYDROCHLORIDEACTIVE INGREDIENTNLJ6390P1Z1
GUAIFENESINACTIVE INGREDIENT495W7451VQ1
EPHEDRINEACTIVE MOIETYGN83C131XS1
GUAIFENESINACTIVE MOIETY495W7451VQ1

Products#

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

DailyMed product names page 1 of 1 · 10 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
65193-32065193-320-24

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 7 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
2b062522-4db6-4a2a-8d01-9ca8b8722790172e970d-6773-4796-a280-3370e2f46c692019-03-28WarningsExact identifier
spl id: 2b062522-4db6-4a2a-8d01-9ca8b8722790
spl set id: 172e970d-6773-4796-a280-3370e2f46c69

Reported adverse events (FAERS/openFDA)#

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