PRIMATENE- ephedrine hydrochloride tablet 
Foundation Consumer Brands

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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Primatene®

Drug Facts

Active ingredient (in each tablet)

Ephedrine HCl 12.5 mg

Purpose

Bronchodilator

Use

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

Directions

Other information

Inactive ingredients

D&C yellow #10 aluminum lake, dibasic calcium phosphate dihydrate, FD&C yellow #6 aluminum lake, magnesium stearate, microcrystalline cellulose, silicon dioxide, sodium starch glycolate, stearic acid

Questions or comments?

Call 1-800-535-0026 weekdays 9 AM to 5 PM EST

Distributed by:
Foundation Consumer Brands, LLC
Pittsburgh, PA 15212

PRINCIPAL DISPLAY PANEL - 12.5 mg Tablet Blister Pack Carton

NEW FORMULA

Primatene®
TABLETS

Ephedrine HCl 12.5 mg • Bronchodilator

For the Temporary Relief of Mild Symptoms of
INTERMITTENT ASTHMA

24 TABLETS

PRINCIPAL DISPLAY PANEL - 12.5 mg Tablet Blister Pack Carton
PRIMATENE 
ephedrine hydrochloride tablet
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:80070-600
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
EPHEDRINE HYDROCHLORIDE (UNII: NLJ6390P1Z) (EPHEDRINE - UNII:GN83C131XS) EPHEDRINE HYDROCHLORIDE12.5 mg
Inactive Ingredients
Ingredient NameStrength
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
DIBASIC CALCIUM PHOSPHATE DIHYDRATE (UNII: O7TSZ97GEP)  
D&C YELLOW NO. 10 ALUMINUM LAKE (UNII: CQ3XH3DET6)  
FD&C YELLOW NO. 6 (UNII: H77VEI93A8)  
MAGNESIUM STEARATE (UNII: 70097M6I30)  
MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U)  
SODIUM STARCH GLYCOLATE TYPE A POTATO (UNII: 5856J3G2A2)  
STEARIC ACID (UNII: 4ELV7Z65AP)  
Product Characteristics
ColorYELLOW (Light yellow color) Scoreno score
ShapeROUNDSize8mm
FlavorImprint Code PT;in;circle;engraved
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:80070-600-242 in 1 CARTON01/22/2021
112 in 1 BLISTER PACK; Type 0: Not a Combination Product
2NDC:80070-600-605 in 1 CARTON01/22/2021
212 in 1 BLISTER PACK; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC MONOGRAPH FINALpart34101/22/2021
Labeler - Foundation Consumer Brands (117603632)

Revised: 1/2021
Document Id: 36209716-0092-4824-9aaa-aa2c582d3b63
Set id: 2170f081-c03f-47e8-bc63-4052c5e653fa
Version: 1
Effective Time: 20210125
 
Foundation Consumer Brands