OTC - ACTIVE INGREDIENT SECTION
Active Ingredient(In Each Tablet): Ephedrine HCl 25 mg, Guaifenesin 200 mg
Active Ingredient(In Each Tablet): Ephedrine HCl 25 mg, Guaifenesin 200 mg
Purposes - Bronchodilator, Expectorant
• 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.
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.
If pregnant or breast feeding, ask a health proffessional before use
Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center right away.
• 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 Ingredients: Maltodextrin, Microcrystalline Cellulose, Povidone, Sodium Starch Glycolate,Stearic Acid
| Class | Version | Type | Effective |
|---|---|---|---|
| EPHEDRINE Pharmacologic Class Indexing | 2 | Indexing - Pharmacologic Class | 20180813 |
| GUAIFENESIN Pharmacologic Class Indexing | 1 | Indexing - Pharmacologic Class | 20211129 |
| Product concept | Relation | Version | Effective |
|---|---|---|---|
| d1bd959e-e326-44fb-b8ca-8c56a84a2a3d | Product name | 2 | 20251211 |
| f1d178e1-1663-4c63-ae37-62a1b322fba4 | Product name | 2 | 20251106 |
| f606d3ac-dd63-4b29-bea0-db23753b8ddc | Product name | 1 | 20220118 |
| 30254138-2d98-4aa2-8e07-ae82e8b0a389 | Product name | 3 | 20171103 |
| fee762de-ffd9-404d-8bc6-8c0c208e758d | Product name | 1 | 20170426 |
| 4fe95224-f543-4dbb-9445-8cca122b48c8 | Product name | 1 | 20150609 |
| e8718272-64cb-4436-969b-176c3067c8f4 | Product name | 1 | 20150609 |
| 106ff02a-57e1-4c4c-a307-fd582ff4e311 | Product name | 1 | 20150212 |
| NDC | Effective | Action | Document | Indexing SPL | Related label |
|---|---|---|---|---|---|
| 65193-320-24 | 2023-01-30 | C162847 | 48780-1 | f386c64a-4268-0266-e053-dadaa90a7c1a | DRUG FACTS |
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 65193-320-24 | Ephed Asthma | 24 in 1 BLISTER PACK | TABLET | 24 | 3 |
| Ingredient | Type | UNII | SPL version | Uploaded |
|---|---|---|---|---|
| EPHEDRINE HYDROCHLORIDE | ACTIVE INGREDIENT | NLJ6390P1Z | 1 | |
| GUAIFENESIN | ACTIVE INGREDIENT | 495W7451VQ | 1 | |
| EPHEDRINE | ACTIVE MOIETY | GN83C131XS | 1 | |
| GUAIFENESIN | ACTIVE MOIETY | 495W7451VQ | 1 |
Every source-derived product name is available through these pages.
| Product NDC | Package NDC |
|---|---|
| 65193-320 | 65193-320-24 |
Every source-derived ingredient row is available through these pages.
| Name | UNII | Kind |
|---|---|---|
| EPHEDRINE HYDROCHLORIDE | NLJ6390P1Z | ACTIB |
| GUAIFENESIN | 495W7451VQ | ACTIB |
| POVIDONE K30 | U725QWY32X | IACT |
| STEARIC ACID | 4ELV7Z65AP | IACT |
| CELLULOSE, MICROCRYSTALLINE | OP1R32D61U | IACT |
| SODIUM STARCH GLYCOLATE TYPE A POTATO | 5856J3G2A2 | IACT |
| MALTODEXTRIN | 7CVR7L4A2D | IACT |
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.
| Brand | Generic | Manufacturer | SPL set ID | Effective date | Available safety fields | Join |
|---|---|---|---|---|---|---|
| 2b062522-4db6-4a2a-8d01-9ca8b8722790 | 172e970d-6773-4796-a280-3370e2f46c69 | 2019-03-28 | Warnings | 2b062522-4db6-4a2a-8d01-9ca8b8722790 172e970d-6773-4796-a280-3370e2f46c69 |
Adverse event summaries are temporarily unavailable. Other product information remains available.