Prime Asthma Relief

Manufacturer
DRNATURALHEALING | Star Health and Beauty LLC
Effective date
2014-06-19
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-05-31 22:40:02

Label at a glance#

ProductPRIME ASTHMA RELIEF
Active ingredientEPINEPHRINE
Label structure11 sections

Dosage and administration

do not use more than directed adults and children 4 years of age and over: 1 capsule is for one inhalation at one time inhalation 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 1) The active ingredient in a dry powder is 0.22 mg per capsule (the concentration is 1% epi...

Storage and handling

Protect from light Place in a dry area Avoid excessive heat Store between 2°C and 24°C (36°F and 75°F)

Label contents#

Full prescribing information#

ACTIVE INGREDIENT

OTC - ACTIVE INGREDIENT SECTION

Epinephrine, USP 0.22 mg per capsule/dose

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

  • are not better in 20 minutes
  • get worse
  • need more than 6 inhalations in 24 hours
  • use more than 4 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

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 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.

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 doctor if

OTC - STOP USE SECTION

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

PREGNANCY OR BREAST FEEDING

OTC - PREGNANCY OR BREAST FEEDING SECTION

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

KEEP OUT OF REACH OF CHILDREN

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 use more than directed
  • adults and children 4 years of age and over: 1 capsule is for one inhalation at one time
  • inhalation 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

1) The active ingredient in a dry powder is 0.22 mg per capsule (the concentration is 1% epinephrine in the total weight of the dry powder)

2) For use in a dry powder inhaler for holding the No. 3 capsule.

3) Should orally inhale at least two times after the capsule is pierced to make sure all dry powder is inhaled into the lung

4) Instructions for Inhalation:
A. Inhaler parts: image of inhalerimage of inhaler

B. Instructions for using the dry powder inhaler:
Wash and dry your hands completely before touching the inhaler and capsule.
image of capimage of cap (1) Remove the cap.
image of capimage of cap (2) Hold the inhaler at base and turn the mouthpiece in direction of the arrow.
image of blister packimage of blister pack (3) Obtain 1 capsule from the blister package just prior to use.
image of inhalerimage of inhaler (4) Open inhaler by turning mouthpiece as indicated. Load 1 capsule in the capsule-chamber of the inhaler. Do not put the capsule directly into the top of the mouthpiece. Twist the mouthpiece to the closed position.
image of inhalerimage of inhaler (5) Hold the inhaler upright, push/click two blue buttons inwards all the way. Let go of the blue buttons. Do not press the blue buttons more than 1 time. The chances of the capsule breaking into pieces will be increased if the capsule is accidentally pierced more than once.
(6) With the inhaler away from your mouth, prepare by breathing out (exhaling) all the way. Do not blow or exhale into the mouthpiece.
image of inhalerimage of inhaler (7) Hold the inhaler horizontally. Place your mouth over the mouthpiece and close your lips tightly around it. Inhale quickly and deeply.
(8) Hold your breath for count of ten, or as long as is comfortable. Breathe out gently. You will need to inhale at least twice from one capsule in order to get the full dose.
(9) After the dose, open the mouthpiece, remove the used capsule, and take a look at the used capsule. It should be pierced and empty. If so, dispose of it properly. If the capsule does not look pierced, put the capsule back into the device capsule-chamber, repeat steps 7, 8 and 9.
(10) Cover the mouthpiece and dust cap for storage.
(11) After your Inhalation, throw away the empty capsule properly as it is bio-degradable. Do not store the capsule in the inhaler. Put the mouthpiece back to your inhaler device and twist the mouthpiece in a clockwise direction until it is tight. Do not over-tighten.

HOW SUPPLIED

HOW SUPPLIED SECTION

  1. Epinephrine Inhalation is a dry powder, USP 0.22 mg, in one number 3 capsule.
  2. NDC 15343-104-20, each dose is in an individual capsule. Twenty capsules are packed in one blister. The dry powder in the capsule is in a ready-to-inhale form.

STORAGE AND HANDLING

STORAGE AND HANDLING SECTION

  1. Protect from light
  2. Place in a dry area
  3. Avoid excessive heat
  4. Store between 2°C and 24°C (36°F and 75°F)

INACTIVE INGREDIENT

INACTIVE INGREDIENT SECTION

Lactose

REGULATORY STATUS

SPL UNCLASSIFIED SECTION

OTC Monograph 2013, 21 CFR Part 341.16 and 341.76 Bronchodilator

COMMENTS AND QUESTIONS

OTC - QUESTIONS SECTION

1-888-658-8108
Monday through Friday, 8:00 a.m. to 5:00 p.m. (Eastern Standard Time)

Manufactured for: DrNaturalHealing, Inc. 111 McCoy Street Milford, DE 19963, USA Info@DrNaturalHealing.com

Principal Display Panel

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

image of carton
image of carton
image of carton
image of carton
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DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
1546217EPINEPHrine 0.22 MG Inhalation PowderPSN1
1546217epinephrine 0.22 MG Inhalation PowderSCD1

DailyMed Pharmacologic Classes#

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

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
0b4ec9ca-d305-43fc-88dd-7a510313efe0Product name120260105
bb209f42-a85f-4fee-9d3d-c9dded168625Product name120251208
49628fc7-2031-4c28-bd31-0ef3aa8f44a3Product name320251118
cbf85893-59ef-423f-87d4-a573c000a8b9Product name820250731
b5b1095b-40cd-8a9e-b111-502545045b07Product name420250325
e190029e-423b-473c-8e04-2ada59b5b711Product name120250314
e0031c74-3853-42bc-8e10-86dbbe83992eProduct name220231116
f7046b89-2016-499a-adc6-78479172abc6Product name120230425
2686d634-e712-4007-8dbf-3d37c6c4d71fProduct name120181121
fa8b5901-e681-426f-82fe-54f6d81ec698Product name420180619
bd49bb86-2d32-4a7a-a594-eeda2e29af42Product name120180118
c08ab52f-2fc8-4409-9d9f-ed8edc0bd070Product name120171221
3becbe78-12d9-4ad2-9b4c-1e36f8d1303aProduct name120170815

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
15343-104-202019-11-27C16284748780-19855e2a2-3b64-60a7-e053-dbdaa90a05bd6d5af590-59f6-4f34-95ff-226a2996f985
15343-105-402019-11-27C16284748780-19855e2a2-3b64-60a7-e053-dbdaa90a05bd6d5af590-59f6-4f34-95ff-226a2996f985

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
15343-104-20Prime Asthma Relief1 in 1 CARTONKIT11
15343-105-40PRIME ASTHMA RELIEF1 in 1 CARTONCAPSULE11
15343-105-40PRIME ASTHMA RELIEF40 in 1 BLISTER PACKCAPSULE401

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
15343-104PRIME ASTHMA RELIEF (EPINEPHRINE) CAPSULE PRIME ASTHMA RELIEF (EPINEPHRINE) KIT [DRNATURALHEALING]1Legacy NDC, 1 package rows20140821_6d5af590-59f6-4f34-95ff-226a2996f985.zip
15343-105PRIME ASTHMA RELIEF (EPINEPHRINE) CAPSULE PRIME ASTHMA RELIEF (EPINEPHRINE) KIT [DRNATURALHEALING]1Legacy NDC, 2 package rows20140821_6d5af590-59f6-4f34-95ff-226a2996f985.zip

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIISPL versionUploaded
EPINEPHRINEACTIVE INGREDIENTYKH834O4BH1
EPINEPHRINEACTIVE MOIETYYKH834O4BH1
LACTOSEINACTIVE INGREDIENTJ2B2A4N98G1

Products#

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

DailyMed product names page 1 of 1 · 3 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
15343-10415343-104-20
15343-10515343-105-40

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 4 matching rows.

Name, UNII, Kind table
NameUNIIKind
EPINEPHRINEYKH834O4BHACTIB
LACTOSEJ2B2A4N98GIACT
EPINEPHRINEYKH834O4BHACTIB
LACTOSEJ2B2A4N98GIACT

Source Document#

Source XML

Inactive ingredient matches#

Inactive Ingredient Database values describe FDA-listed use contexts. The match method and ambiguity count are shown because ingredient names, routes, and dosage forms are not always unique. Browse recovered IID releases and source provenance.

Inactive ingredient links page 1 of 1 · 36 matching rows.

DailyMed ingredient, IID ingredient, UNII table
DailyMed ingredientIID ingredientUNIIDosage form / routePotencyMaximum daily exposureMatch
LACTOSELACTOSEJ2B2A4N98GCAPSULE, COATED, EXTENDED RELEASE / ORALNAExact identifier — unii candidate
36 equally ranked IID candidates
LACTOSELACTOSEJ2B2A4N98GOINTMENT / TOPICALNAExact identifier — unii candidate
36 equally ranked IID candidates
LACTOSELACTOSEJ2B2A4N98GINJECTION, SOLUTION / INTRAVENOUS0.45 %w/vExact identifier — unii candidate
36 equally ranked IID candidates
LACTOSELACTOSEJ2B2A4N98GSOLUTION / RECTAL8 %w/vExact identifier — unii candidate
36 equally ranked IID candidates
LACTOSELACTOSEJ2B2A4N98GTABLET, SUGAR COATED / ORALNAExact identifier — unii candidate
36 equally ranked IID candidates
LACTOSELACTOSEJ2B2A4N98GCAPSULE, EXTENDED RELEASE / ORAL120 mgExact identifier — unii candidate
36 equally ranked IID candidates
LACTOSELACTOSEJ2B2A4N98GFILM, EXTENDED RELEASE / TRANSDERMAL675 mgExact identifier — unii candidate
36 equally ranked IID candidates
LACTOSELACTOSEJ2B2A4N98GINJECTION, POWDER, LYOPHILIZED, FOR SOLUTION / INTRACAVITARY193.8 mgExact identifier — unii candidate
36 equally ranked IID candidates
LACTOSELACTOSEJ2B2A4N98GCAPSULE / RESPIRATORY (INHALATION)44.4 mgExact identifier — unii candidate
36 equally ranked IID candidates
LACTOSELACTOSEJ2B2A4N98GPOWDER / RESPIRATORY (INHALATION)90 mgExact identifier — unii candidate
36 equally ranked IID candidates
LACTOSELACTOSEJ2B2A4N98GINJECTION / INTRAMUSCULAR203.5 mgExact identifier — unii candidate
36 equally ranked IID candidates
LACTOSELACTOSEJ2B2A4N98GINJECTION, POWDER, FOR SOLUTION / INTRAVENOUS133 mgExact identifier — unii candidate
36 equally ranked IID candidates
LACTOSELACTOSEJ2B2A4N98GGRANULE, FOR SUSPENSION / ORAL512.5 mg/5mlExact identifier — unii candidate
36 equally ranked IID candidates
LACTOSELACTOSEJ2B2A4N98GPOWDER, FOR SOLUTION / ORALNAExact identifier — unii candidate
36 equally ranked IID candidates
LACTOSELACTOSEJ2B2A4N98GTABLET / ORAL2500 mgExact identifier — unii candidate
36 equally ranked IID candidates
LACTOSELACTOSEJ2B2A4N98GSUPPOSITORY / VAGINALNAExact identifier — unii candidate
36 equally ranked IID candidates
LACTOSELACTOSEJ2B2A4N98GINJECTION, POWDER, FOR SOLUTION / INTRAMUSCULAR133 mgExact identifier — unii candidate
36 equally ranked IID candidates
LACTOSELACTOSEJ2B2A4N98GCREAM / VAGINAL3 %w/wExact identifier — unii candidate
36 equally ranked IID candidates
LACTOSELACTOSEJ2B2A4N98GTABLET / BUCCAL296.7 mgExact identifier — unii candidate
36 equally ranked IID candidates
LACTOSELACTOSEJ2B2A4N98GPOWDER / VAGINAL430 mgExact identifier — unii candidate
36 equally ranked IID candidates
LACTOSELACTOSEJ2B2A4N98GTABLET, FILM COATED / ORAL590 mgExact identifier — unii candidate
36 equally ranked IID candidates
LACTOSELACTOSEJ2B2A4N98GTABLET, EFFERVESCENT / ORAL96.5 mgExact identifier — unii candidate
36 equally ranked IID candidates
LACTOSELACTOSEJ2B2A4N98GTABLET / SUBLINGUAL352 mgExact identifier — unii candidate
36 equally ranked IID candidates
LACTOSELACTOSEJ2B2A4N98GTABLET, COATED / ORAL332.05 mgExact identifier — unii candidate
36 equally ranked IID candidates
LACTOSELACTOSEJ2B2A4N98GTABLET / RECTAL20 mgExact identifier — unii candidate
36 equally ranked IID candidates
LACTOSELACTOSEJ2B2A4N98GTABLET, FILM COATED, EXTENDED RELEASE / ORAL620 mgExact identifier — unii candidate
36 equally ranked IID candidates
LACTOSELACTOSEJ2B2A4N98GINJECTION, POWDER, FOR SOLUTION / SUBCUTANEOUS133 mgExact identifier — unii candidate
36 equally ranked IID candidates
LACTOSELACTOSEJ2B2A4N98GTABLET, CHEWABLE / ORAL1412 mgExact identifier — unii candidate
36 equally ranked IID candidates
LACTOSELACTOSEJ2B2A4N98GSOLUTION / ORAL1682 mg/15mlExact identifier — unii candidate
36 equally ranked IID candidates
LACTOSELACTOSEJ2B2A4N98GTABLET, EXTENDED RELEASE / ORAL400 mgExact identifier — unii candidate
36 equally ranked IID candidates
LACTOSELACTOSEJ2B2A4N98GCAPSULE / ORAL530 mgExact identifier — unii candidate
36 equally ranked IID candidates
LACTOSELACTOSEJ2B2A4N98GCAPSULE, DELAYED RELEASE / ORAL231.84 mgExact identifier — unii candidate
36 equally ranked IID candidates
LACTOSELACTOSEJ2B2A4N98GTABLET, DELAYED RELEASE / ORAL160 mgExact identifier — unii candidate
36 equally ranked IID candidates
LACTOSELACTOSEJ2B2A4N98GCONCENTRATE / ORALNAExact identifier — unii candidate
36 equally ranked IID candidates
LACTOSELACTOSEJ2B2A4N98GINJECTION / INTRAVENOUS203.5 mgExact identifier — unii candidate
36 equally ranked IID candidates
LACTOSELACTOSEJ2B2A4N98GCAPSULE, COATED PELLETS / ORAL135.2 mgExact identifier — unii candidate
36 equally ranked IID candidates

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
d577c12a-e6b8-4660-ada0-2b62cf8e852a6d5af590-59f6-4f34-95ff-226a2996f9852014-06-19WarningsExact identifier
spl id: d577c12a-e6b8-4660-ada0-2b62cf8e852a
spl set id: 6d5af590-59f6-4f34-95ff-226a2996f985

Reported adverse events (FAERS/openFDA)#

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