EPHEDRINE SULFATE tablet, film coated

Ephedrine Sulfate by

Drug Labeling and Warnings

Ephedrine Sulfate by is a Otc medication manufactured, distributed, or labeled by CVS Pharmacy, Inc. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Drug Facts

Active ingredient (in each caplet)
Ephedrine Sulfate 25 mg

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.

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

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)

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

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

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

Keep out of reach of children.

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

SPL UNCLASSIFIED SECTION

* 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.

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

INGREDIENTS AND APPEARANCE

EPHEDRINE SULFATE 
ephedrine sulfate tablet, film coated

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 69842-922
Route of Administration	ORAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
EPHEDRINE SULFATE (UNII: U6X61U5ZEG) (EPHEDRINE - UNII:GN83C131XS)	EPHEDRINE SULFATE	25 mg

Inactive Ingredients
Ingredient Name	Strength
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)
SODIUM STARCH GLYCOLATE TYPE A POTATO (UNII: 5856J3G2A2)
MAGNESIUM STEARATE (UNII: 70097M6I30)
MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U)
DIBASIC CALCIUM PHOSPHATE DIHYDRATE (UNII: O7TSZ97GEP)
TALC (UNII: 7SEV7J4R1U)
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
HYPROMELLOSES (UNII: 3NXW29V3WO)
MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)
POLYDEXTROSE (UNII: VH2XOU12IE)

Product Characteristics
Color	white	Score	no score
Shape	OVAL	Size	15mm
Flavor		Imprint Code	57;89
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 69842-922-07	5 in 1 CARTON	12/28/2022
1		12 in 1 BLISTER PACK; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part341	12/28/2022

Labeler - CVS Pharmacy, Inc (062312574)