Label: EPHEDRINE SULFATE tablet, film coated
- NDC Code(s): 0363-5789-07
- Packager: Walgreen Company
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: OTC monograph final
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.
Drug Label Information
Updated September 22, 2022
If you are a consumer or patient please visit this version.
- Download DRUG LABEL INFO: PDF XML
- Official Label (Printer Friendly)
- Drug Facts
Asthma alert: Because asthma may be life threatening, see a doctor if you
are not better in 60 minutes
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
high blood pressure
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
- Other information
- INACTIVE INGREDIENT
- Questions or comments?
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 ©2022 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
INGREDIENTS AND APPEARANCE
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 final part341 07/22/2022 Labeler - Walgreen Company (008965063) Registrant - Contract Pharmacal Corp. (057795122)