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NDC 00487-2784-01 Asthmanefrin 11.25 mg/.5mL Details
Asthmanefrin 11.25 mg/.5mL
Asthmanefrin is a RESPIRATORY (INHALATION) SOLUTION in the HUMAN OTC DRUG category. It is labeled and distributed by Nephron Pharmaceuticals Corporation. The primary component is RACEPINEPHRINE HYDROCHLORIDE.
Product Information
| NDC | 00487-2784 |
|---|---|
| Product ID | 0487-2784_b8a6aed9-a173-f172-e053-2995a90a17a0 |
| Associated GPIs | 44202060012530 |
| GCN Sequence Number | 054686 |
| GCN Sequence Number Description | racepinephrine HCl VIAL-NEB 2.25 % INHALATION |
| HIC3 | A1D |
| HIC3 Description | GENERAL BRONCHODILATOR AGENTS |
| GCN | 22696 |
| HICL Sequence Number | 025002 |
| HICL Sequence Number Description | RACEPINEPHRINE HCL |
| Brand/Generic | Brand |
| Proprietary Name | Asthmanefrin |
| Proprietary Name Suffix | n/a |
| Non-Proprietary Name | racepinephrine hydrochloride |
| Product Type | HUMAN OTC DRUG |
| Dosage Form | SOLUTION |
| Route | RESPIRATORY (INHALATION) |
| Active Ingredient Strength | 11.25 |
| Active Ingredient Units | mg/.5mL |
| Substance Name | RACEPINEPHRINE HYDROCHLORIDE |
| Labeler Name | Nephron Pharmaceuticals Corporation |
| Pharmaceutical Class | n/a |
| DEA Schedule | n/a |
| Marketing Category | OTC MONOGRAPH FINAL |
| Application Number | part341 |
| Listing Certified Through | 2024-12-31 |
Package
Package Images
NDC 00487-2784-01 (00487278401)
| NDC Package Code | 0487-2784-01 |
|---|---|
| Billing NDC | 00487278401 |
| Package | 30 POUCH in 1 CARTON (0487-2784-01) / 1 VIAL, SINGLE-USE in 1 POUCH / .5 mL in 1 VIAL, SINGLE-USE |
| Marketing Start Date | 2012-08-01 |
| NDC Exclude Flag | N |
| Pricing Information | N/A |
Standard Product Labeling (SPL)/Prescribing Information SPL 80480838-832c-4fdd-9f8e-f6f877ae3549 Details
Active ingredient (in each 0.5 ml)
Uses
Warnings
Asthma alert: Because asthma may be life threatening, see a doctor if you:
- Are not better in 20 minutes
- Get worse
- Need more than 12 inhalations in 24 hours
- Use more than 9 inhalations 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.
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 a MAOI, ask a doctor or pharmacist before taking this product.
- If product is brown in color or cloudy
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
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).
Stop use and ask a doctor if:
- Your asthma is getting worse (See Asthma alert)
- You have difficulty sleeping
- You have a rapid heartbeat
- You have tremors, nervousness, or seizure
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.
Directions
- The ingredient is used in an aqueous solution at a concentration equivalent to 1 percent epinephrine.
- Do not use more than directed
- For use in a hand-held rubber bulb nebulizer:
- Add 0.5 mL (contents of one vial) of solution to nebulizer.
- Adults and children 4 years of age and over:
1 to 3 inhalations not more often than every 3 hours.
Do not use more than 12 inhalations in 24 hours.
The use of this product by children should be supervised by an adult. - Children under 4 years of age: ask a doctor.
Other Information
Storage and Handling
- Protect from light. Avoid excessive heat. Protect from freezing.
- Store between 2°C and 25°C (36°F and 77°F).
- How Supplied: Asthmanefrin
® Racepinephrine Inhalation Solution, USP 2.25% is supplied in 0.5 mL sterile vials.
NDC 0487-2784-01 30 vials, each vial in an individual foil pouch.
Questions?
SPL UNCLASSIFIED SECTION
PRINCIPAL DISPLAY PANEL - 0.5 mL Vial Carton
INGREDIENTS AND APPEARANCE
| ASTHMANEFRIN
racepinephrine hydrochloride solution |
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| Labeler - Nephron Pharmaceuticals Corporation (079160190) |
| Registrant - Nephron SC, Inc. (079160190) |
| Establishment | |||
| Name | Address | ID/FEI | Business Operations |
|---|---|---|---|
| Nephron SC, Inc. | 079160190 | analysis(0487-2784) , pack(0487-2784) , manufacture(0487-2784) , label(0487-2784) | |
Revised: 1/2021
Document Id: b8a6aed9-a173-f172-e053-2995a90a17a0
Set id: 80480838-832c-4fdd-9f8e-f6f877ae3549
Version: 8
Effective Time: 20210111