5789 - Walgreen

5789 - Walgreen
SPL v4
SPL
SPL Set ID dc0072f9-7111-1af0-e053-2a95a90aed56
Route
ORAL
Published
Effective Date 2025-09-04
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Ephedrine (25 mg)
Inactive Ingredients
Silicon Dioxide Microcrystalline Cellulose Polydextrose Calcium Phosphate, Dibasic, Dihydrate Titanium Dioxide Magnesium Stearate Sodium Starch Glycolate Type A Potato Hypromelloses Talc Medium-chain Triglycerides

Identifiers & Packaging

Pill Appearance
Imprint: 57;89 Shape: oval Color: white Size: 15 mm Score: 1
Marketing Status
OTC MONOGRAPH DRUG Active Since 2022-07-22

Description

Active ingredient (in each caplet) Ephedrine Sulfate 25 mg


Medication Information

Warnings and Precautions

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.

Description

Active ingredient (in each caplet) Ephedrine Sulfate 25 mg

Use

 for temporary relief of mild symptoms of intermittent asthma:

 wheezing  tightness of chest  shortness of breath

Section 34088-5

In case of overdose, get medical help or contact a Poison Control Center right away.

Section 42229-5

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.

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®.

Section 50565-1

Keep out of reach of children.

Section 50566-9

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

Section 50567-7

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

Section 50568-5

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)

Section 50569-3

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

Section 50570-1

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

Section 51727-6

dibasic calcium phosphate dihydrate, hypromellose, magnesium stearate, medium chain triglycerides, microcrystalline cellulose, polydextrose, silicon dioxide, sodium starch glycolate type A, talc, titanium dioxide.

Section 51945-4

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

Section 53414-9

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

Section 55105-1

Purpose

Bronchodilator

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

Drug Facts

Active ingredient (in each caplet)

Ephedrine Sulfate 25 mg

Other Information
  • each caplet contains: calcium 20 mg
  • store in a dry place at 15° – 30°C (59° – 86°F)
Questions Or Comments?

Call 1-800-925-4733


Structured Label Content

Use

 for temporary relief of mild symptoms of intermittent asthma:

 wheezing  tightness of chest  shortness of breath

Warnings and Precautions (34071-1)

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.

Section 34088-5 (34088-5)

In case of overdose, get medical help or contact a Poison Control Center right away.

Section 42229-5 (42229-5)

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.

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®.

Section 50565-1 (50565-1)

Keep out of reach of children.

Section 50566-9 (50566-9)

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

Section 50567-7 (50567-7)

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

Section 50568-5 (50568-5)

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)

Section 50569-3 (50569-3)

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

Section 50570-1 (50570-1)

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

Section 51727-6 (51727-6)

dibasic calcium phosphate dihydrate, hypromellose, magnesium stearate, medium chain triglycerides, microcrystalline cellulose, polydextrose, silicon dioxide, sodium starch glycolate type A, talc, titanium dioxide.

Section 51945-4 (51945-4)

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

Section 53414-9 (53414-9)

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

Section 55105-1 (55105-1)

Purpose

Bronchodilator

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

Drug Facts

Active ingredient (in each caplet)

Ephedrine Sulfate 25 mg

Other Information (Other information)
  • each caplet contains: calcium 20 mg
  • store in a dry place at 15° – 30°C (59° – 86°F)
Questions Or Comments? (Questions or comments?)

Call 1-800-925-4733


Advanced Ingredient Data


Raw Label Data

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