FDA Label for Ephedrine Sulfate
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 Sulfate Product Label
The following document was submitted to the FDA by the labeler of this product Cvs Pharmacy, Inc. 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 caplet)
Ephedrine Sulfate 25 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 6 caplets in 24 hours
use more than 4 caplets 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 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 caplet every 4 hours as needed.
Do not take more than 6 caplets in 24 hours or as directed by a doctor. |
children under 12
years of age | do not use |
Other Information
each caplet contains: calcium 20 mg
store in a dry place at 15° – 30°C (59° – 86°F)
Inactive Ingredient
dibasic calcium phosphate dihydrate, hypromellose, magnesium stearate, medium chain triglycerides, microcrystalline cellulose, polydextrose, silicon dioxide, sodium starch glycolate type A, talc, titanium dioxide.
Questions Or Comments?
Call 1-800-231-4670
Other
* This product is not manufactured or distributed by Foundation Consumer Healthcare, LLC., owner of the registered trademark
Bronkaid®.
RETAIN OUTER CARTON FOR COMPLETE PRODUCT INFORMATION
TAMPER EVIDENT: DO NOT USE IF CARTON HAS BEEN OPENED OR BLISTER UNITS ARE TORN OR BROKEN
Distributed by: CVS Pharmacy, Inc.
One CVS Drive, Woonsocket, RI 02895
© 2022 CVS/pharmacy
CVS.com® 1-800-SHOP CVS
Product of India. Manufactured and packaged in the U.S.A. using domestic and imported ingredients.
Package Label.Principal Display Panel
Compare to the active ingredient in Bronkaid® Max*
MAXIMUM STRENGTH**
Asthma Relief
EPHEDRINE SULFATE CAPLETS, 25 mg Bronchodilator
**STRONGEST 1 CAPLET DOSE AVAILABLE WITHOUT
A PRESCRIPTION
Relieves mild, intermittent asthma
symptoms & restores free breathing
60 Caplets
* Please review the disclaimer below.