EPHEDRINE HYDROCHLORIDE tablet

Ephedrine Hydrochloride by

Drug Labeling and Warnings

Ephedrine Hydrochloride by is a Otc medication manufactured, distributed, or labeled by Walgreen Company. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Drug Facts

Active ingredient (in each tablet)
Ephedrine Hydrochloride 12.5 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 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

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 the 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 1-2 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

Other information

• store in a dry place at 15° – 30°C (59° – 86°F).

INACTIVE INGREDIENT

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

Questions or comments?

Call 1-800-925-4733

SPL UNCLASSIFIED SECTION

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®.

PRINCIPAL DISPLAY PANEL

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

INGREDIENTS AND APPEARANCE

EPHEDRINE HYDROCHLORIDE 
ephedrine hydrochloride tablet

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 0363-9812
Route of Administration	ORAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
EPHEDRINE HYDROCHLORIDE (UNII: NLJ6390P1Z) (EPHEDRINE - UNII:GN83C131XS)	EPHEDRINE HYDROCHLORIDE	12.5 mg

Inactive Ingredients
Ingredient Name	Strength
D&C YELLOW NO. 10 ALUMINUM LAKE (UNII: CQ3XH3DET6)
MAGNESIUM STEARATE (UNII: 70097M6I30)
MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U)
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
STEARIC ACID (UNII: 4ELV7Z65AP)
CROSPOVIDONE (UNII: 2S7830E561)

Product Characteristics
Color	yellow	Score	no score
Shape	ROUND	Size	6mm
Flavor		Imprint Code	1298
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 0363-9812-07	4 in 1 CARTON	12/02/2021
1		15 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	12/02/2021

Labeler - Walgreen Company (008965063)