PRIMATENE- ephedrine hcl, guaifenesin tablet 
GlaxoSmithKline Consumer Healthcare Holdings (US) LLC

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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Drug Facts

ACTIVE INGREDIENTS (IN EACH TABLET)

Ephedrine HCl, USP 12.5 mg

Guaifenesin, USP 200 mg

PURPOSES

Bronchodilator

Expectorant

USES

for temporary relief of mild symptoms of intermittent asthma:
wheezing
tightness of chest
shortness of breath
helps loosen phlegm (mucus) and thin bronchial secretions to rid bronchial passageways of bothersome mucus, and to make coughs more productive

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

do not take more than directed
agedose

adults and children 12 years of age and over

oral 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 age

ask a doctor

OTHER INFORMATION

store at 20-25°C (68-77°F)

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

NDC 0573-2952-20

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 DRUGItem Code (Source)NDC:0573-2952
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
EPHEDRINE HYDROCHLORIDE (UNII: NLJ6390P1Z) (EPHEDRINE - UNII:GN83C131XS) EPHEDRINE HYDROCHLORIDE12.5 mg
GUAIFENESIN (UNII: 495W7451VQ) (GUAIFENESIN - UNII:495W7451VQ) GUAIFENESIN200 mg
Inactive Ingredients
Ingredient NameStrength
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
CROSPOVIDONE (15 MPA.S AT 5%) (UNII: 68401960MK)  
D&C YELLOW NO. 10 (UNII: 35SW5USQ3G)  
FD&C YELLOW NO. 6 (UNII: H77VEI93A8)  
MAGNESIUM STEARATE (UNII: 70097M6I30)  
MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U)  
POVIDONE, UNSPECIFIED (UNII: FZ989GH94E)  
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 CARTON01/06/2004
112 in 1 BLISTER PACK; Type 0: Not a Combination Product
2NDC:0573-2952-205 in 1 CARTON01/06/2004
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 FINALpart34101/06/2004
Labeler - GlaxoSmithKline Consumer Healthcare Holdings (US) LLC (079944263)
Establishment
NameAddressID/FEIBusiness Operations
Wyeth Pharmaceuticals Company829390975ANALYSIS(0573-2952) , LABEL(0573-2952) , MANUFACTURE(0573-2952) , PACK(0573-2952)

Revised: 11/2020
Document Id: da19db5a-0f16-4f3b-905b-ec7146ddc275
Set id: 9005482c-25ae-d365-33d1-29269532c74d
Version: 6
Effective Time: 20201112
 
GlaxoSmithKline Consumer Healthcare Holdings (US) LLC