EPHEDRINE SULFATE tablet, film coated

Ephedrine Sulfate by

Drug Labeling and Warnings

Ephedrine Sulfate by is a Otc medication manufactured, distributed, or labeled by Walgreen Company, Contract Pharmacal Corp.. 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 1-800-925-4733

SPL UNCLASSIFIED SECTION

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: WALGREEN CO.
200 WILMOT RD., DEERFIELD, IL 60015
walgreens.com ©2023 Walgreen Co.
PRODUCT OF INDIA MANUFACTURED AND PACKAGED IN THE U.S.A. USING DOMESTIC AND IMPORTED INGREDIENTS

††This product is not manufactured or distributed by Foundation Consumer Healthcare, LLC., owner of the registered trademark Bronkaid®.

PRINCIPAL DISPLAY PANEL

NDC: 0363-5789-07

Walgreens

Compare to the active ingredient in Bronkaid® Max††

Asthma Relief

Ephedrine Sulfate 25 mg/ Bronchodilator

Restores free breathing Relief of mild intermittent asthma symptoms

60 Caplets

INGREDIENTS AND APPEARANCE

EPHEDRINE SULFATE 
ephedrine sulfate tablet, film coated

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 0363-5789
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
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U)
POLYDEXTROSE (UNII: VH2XOU12IE)
CALCIUM PHOSPHATE, DIBASIC, DIHYDRATE (UNII: O7TSZ97GEP)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)
MAGNESIUM STEARATE (UNII: 70097M6I30)
SODIUM STARCH GLYCOLATE TYPE A POTATO (UNII: 5856J3G2A2)
HYPROMELLOSES (UNII: 3NXW29V3WO)
TALC (UNII: 7SEV7J4R1U)
MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)

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: 0363-5789-07	5 in 1 CARTON	07/22/2022
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 Drug	M012	07/22/2022

Labeler - Walgreen Company (008965063)

Registrant - Contract Pharmacal Corp. (057795122)