EPHEDRINE SULFATE- ephedrine sulfate capsule 
Hikma Pharmaceuticals USA Inc.

Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

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Ephedrine Sulfate Capsules, USP

Boxed Warning

FOR YOUR PROTECTION, DO NOT USE IF SEAL OVER MOUTH OF BOTTLE IS BROKEN OR MISSING.  CAPUSLES ARE SEALED WITH A RED GELATIN BAND

Active ingredient

(in each capsule)

Ephedrine Sulfate USP, 25 mg

Purpose

Bronchodilator

Indications

For temporary relief of shortness of breath, tightness of chest, and wheezing due to bronchial asthma.  For the temporary relief of bronchial asthma.  Eases breathing for asthma patients by reducing spasms of bronchial muscles.

Warnings

Do not use this product unless a diagnosis of asthma has been made by a doctor.  Do not use this product if you have heart disease, high blood pressure, thyroid disease, diabetes, or difficulty in urination due to enlargement of the prostate gland unless directed by a doctor.  Do not use this product if you have ever been hospitalized for asthma or if you are taking and prescription drug for asthma or if you are taking and prescription drug for asthma unless directed by a doctor.

Drug Interaction precaution

Do not use if you are now taking a prescription monoamine oxidase inhibitor (MAOI) (certain drugs 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 of pharmacist before taking this product.

Ask a doctor before use if you have

heart disease
high blood pressure
thyroid disease
diabetes
trouble urinating due to an enlarged prostate gland

When using this product

Do not use more than directed.  Nervousness, tremor, sleeplessness, nausea or loss of appetite may occur.  Do not continue to use this product, but seek medical assistance immediately if symptoms are not relieved within 1 hour or become worse, consult your doctor.

Stop use and ask a doctor if

Symptoms are not relieved within 1 hour or become worse.  Nervousness, tremor or sleeplessness become worse.  Some users of this product may experience nervousness, tremor, sleeplessness, nausea, and loss of appetite.  If these symptoms persist or become worse, consult your doctor.

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

Adults and children 12 years of age and over:

   

Oral dosage is 12.5 to 25 milligrams every 4 hours, not to exceed 150 milligrams in 24 hours, or as directed by a doctor.  Do not exceed recommended dose unless directed by a doctor.

     
 Children under 12 years of age:    Consult a doctor.

Other information

Store at 20-25°C (68-77°F) [See USP Controlled Room Temperature].  Protect from light and moisture.  Dispense in a tight, light-resistant container as defined in the USP using a child-resistant closure.  You may report side effects to FDA at 1-800-FDA-1088.

Inactive ingredients

Colloidal Silicon Dioxide, Corn Starch, Magnesium Stearate. Capsule shell contains: FD&C Red #3 and Gelatin.

Manufactured by

West-ward Pharmaceutical Corp.
Eatontown, N.J. 07724

Label

Front

Ephedrine Sulfate Capsules 25mg 100s, front of label

Back

Ephedrine Sulfate Capsules, 25mg 100s back of label
EPHEDRINE SULFATE 
ephedrine sulfate capsule
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:0143-3145
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
EPHEDRINE SULFATE (UNII: U6X61U5ZEG) (EPHEDRINE - UNII:GN83C131XS) EPHEDRINE SULFATE25 mg
Inactive Ingredients
Ingredient NameStrength
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
STARCH, CORN (UNII: O8232NY3SJ)  
MAGNESIUM STEARATE (UNII: 70097M6I30)  
FD&C RED NO. 3 (UNII: PN2ZH5LOQY)  
GELATIN (UNII: 2G86QN327L)  
Product Characteristics
ColorPINKScoreno score
ShapeCAPSULESize15mm
FlavorImprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:0143-3145-01100 in 1 BOTTLE; Type 0: Not a Combination Product09/01/199312/31/2015
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC MONOGRAPH FINALpart34609/01/199312/31/2015
Labeler - Hikma Pharmaceuticals USA Inc. (001230762)
Establishment
NameAddressID/FEIBusiness Operations
Hikma Pharmaceuticals USA Inc.001230762MANUFACTURE(0143-3145)

Revised: 11/2019
 
Hikma Pharmaceuticals USA Inc.