1298p-walgreen

1298p-walgreen
SPL v3
SPL
SPL Set ID bcb81dc1-d854-30c0-e053-2a95a90a9fc7
Route
ORAL
Published
Effective Date 2023-12-14
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Ephedrine (12.5 mg)
Inactive Ingredients
D&c Yellow No. 10 Aluminum Lake Magnesium Stearate Microcrystalline Cellulose Silicon Dioxide Stearic Acid Crospovidone

Identifiers & Packaging

Pill Appearance
Imprint: 1298 Shape: round Color: yellow Size: 6 mm Score: 1
Marketing Status
OTC MONOGRAPH DRUG Active Since 2021-12-02

Description

Active ingredient (in each tablet) Ephedrine Hydrochloride 12.5 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 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

Description

Active ingredient (in each tablet) Ephedrine Hydrochloride 12.5 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

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®.

Section 50565-1

Keep out of the 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

crospovidone, D&C yellow #10 lake, magnesium stearate, microcrystalline cellulose, silicon dioxide, stearic acid.

Section 51945-4

Walgreens

NDC 0363-9812-07

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

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 1-2 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

Drug Facts

Active ingredient (in each tablet)

Ephedrine Hydrochloride 12.5 mg

Other Information
  • 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 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

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)

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®.

Section 50565-1 (50565-1)

Keep out of the 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)

crospovidone, D&C yellow #10 lake, magnesium stearate, microcrystalline cellulose, silicon dioxide, stearic acid.

Section 51945-4 (51945-4)

Walgreens

NDC 0363-9812-07

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

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 1-2 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

Drug Facts

Active ingredient (in each tablet)

Ephedrine Hydrochloride 12.5 mg

Other Information (Other information)
  • 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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