FDA Label for Ephedrine Hydrochloride
View Indications, Usage & Precautions
- DRUG FACTS
- OTC - PURPOSE
- USE
- WARNINGS
- OTC - DO NOT USE
- OTC - ASK DOCTOR
- OTC - ASK DOCTOR/PHARMACIST
- OTC - WHEN USING
- OTC - STOP USE
- OTC - PREGNANCY OR BREAST FEEDING
- OTC - KEEP OUT OF REACH OF CHILDREN
- OVERDOSAGE
- DIRECTIONS
- OTHER INFORMATION
- INACTIVE INGREDIENT
- QUESTIONS OR COMMENTS?
- OTHER
- PACKAGE LABEL.PRINCIPAL DISPLAY PANEL
Ephedrine Hydrochloride Product Label
The following document was submitted to the FDA by the labeler of this product Walgreen Company. The document includes published materials associated whith this product with the essential scientific information about this product as well as other prescribing information. Product labels may durg indications and usage, generic names, contraindications, active ingredients, strength dosage, routes of administration, appearance, warnings, inactive ingredients, etc.
Drug Facts
Active ingredient (in each tablet)
Ephedrine Hydrochloride 12.5 mg
Otc - Purpose
Purpose
Bronchodilator
Use
for temporary relief of mild symptoms of intermittent asthma: wheezing tightness of chest shortness of breath
Warnings
Asthma alert: 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
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
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
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
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
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
If pregnant or breast-feeding, ask a health professional before use.
Otc - Keep Out Of Reach Of Children
Keep out of the reach of children.
Overdosage
In case of overdose, get medical help or contact a Poison Control Center right away.
Directions
- do not take more than directed
adults and children 12 years of age 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 Ask a doctor
Other Information
- store in a dry place at 15° – 30°C (59° – 86°F).
Inactive Ingredient
crospovidone, D&C yellow #10 lake, magnesium stearate, microcrystalline cellulose, silicon dioxide, stearic acid.
Questions Or Comments?
Call 1-800-925-4733
Other
TAMPER EVIDENT: DO NOT USE IF CARTON HAS BEEN OPENED OR BLISTER UNITS ARE TORN OR BROKEN
RETAIN THIS CARTON FOR COMPLETE PRODUCT INFORMATION
DISTRIBUTED BY: WALGREEN CO.
200 WILMOT RD., DEERFIELD, IL 60015
†Our pharmacists recommend the Walgreens brand. We invite you to compare to national brands.
††This product is not manufactured or distributed by ARMSTRONG PHARMACEUTICALS, INC., owner of the registered trademark Primatene®.
Package Label.Principal Display Panel
Walgreens
Compare to the active ingredient in Primatene®††
Asthma Relief
EPHEDRINE HCl 12.5 mg / BRONCHODILATOR
• Relief of mild intermittent asthma symptoms
• Restores free breathing
60 Tablets
* Please review the disclaimer below.