PRIMATENE- ephedrine hydrochloride and guaifenesin tablet 
Pfizer Consumer Healthcare

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® Tablets

DRUG FACTS

ACTIVE INGREDIENTS (IN EACH TABLET)

Ephedrine HCl, USP 12.5 mg

Guaifenesin, USP 200 mg

PURPOSES

Bronchodilator

Expectorant

USES

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.

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
  • cough that occurs with too much phlegm (mucus)
  • cough that lasts or is chronic such as occurs with smoking, asthma, chronic bronchitis, or emphysema

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)

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
  • cough lasts more than 7 days, comes back, or is accompanied by fever, rash, or persistent headache. These could be signs of a serious condition.

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

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

agedose
adults and children 12 years of age and overoral dose is 1-2 tablets (12.5 to 25 mg) every 4 hours as needed. Do not take more than 12 tablets (150 mg) in 24 hours
children under 12 years of ageask a doctor

OTHER INFORMATION

INACTIVE INGREDIENTS

colloidal silicon dioxide, crospovidone, D&C yellow no. 10 aluminum lake, FD&C yellow no. 6 aluminum lake, magnesium stearate, microcrystalline cellulose, povidone

QUESTIONS OR COMMENTS?

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

For most recent product information, visit www.PrimateneTablets.com

PRINCIPAL DISPLAY PANEL - 60 Tablet Carton

Primatene®
TABLETS

Ephedrine HCl, Bronchodilator/Guaifenesin, Expectorant
Helps Loosen Phlegm (Mucus)

For the Temporary Relief of Mild Symptoms of
INTERMITTENT ASTHMA

60 TABLETS

Principal Display Panel - 60 Tablet Carton
PRIMATENE 
ephedrine hcl, guaifenesin tablet
Product Information
Product TypeHUMAN OTC DRUG LABELItem Code (Source)NDC:0573-2952
Route of AdministrationORALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
EPHEDRINE HYDROCHLORIDE (EPHEDRINE) EPHEDRINE HYDROCHLORIDE12.5 mg
GUAIFENESIN (GUAIFENESIN) GUAIFENESIN200 mg
Inactive Ingredients
Ingredient NameStrength
SILICON DIOXIDE 
CROSPOVIDONE 
D&C YELLOW NO. 10 
FD&C YELLOW NO. 6 
MAGNESIUM STEARATE 
CELLULOSE, MICROCRYSTALLINE 
POVIDONES 
Product Characteristics
ColorYELLOW (Light yellow color) Scoreno score
ShapeROUNDSize8mm
FlavorImprint Code P;in;circle;engraved;bisect
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:0573-2952-102 in 1 CARTON
112 in 1 BLISTER PACK
2NDC:0573-2952-205 in 1 CARTON
212 in 1 BLISTER PACK
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC MONOGRAPH FINALpart34101/06/2004
Labeler - Pfizer Consumer Healthcare (828831730)
Establishment
NameAddressID/FEIBusiness Operations
Wyeth Pharmaceuticals Company, Consumer Site829390975ANALYSIS(0573-2952), LABEL(0573-2952), MANUFACTURE(0573-2952), PACK(0573-2952)

Revised: 2/2013
Document Id: 983b7623-b288-48db-961c-64dcc6a758c1
Set id: 9005482c-25ae-d365-33d1-29269532c74d
Version: 4
Effective Time: 20130204
 
Pfizer Consumer Healthcare