PRIMATENE- ephedrine hcl, guaifenesin tablet

PRIMATENE by

Drug Labeling and Warnings

PRIMATENE by is a Otc medication manufactured, distributed, or labeled by GlaxoSmithKline Consumer Healthcare Holdings (US) LLC, Wyeth Pharmaceuticals Company. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

SPL UNCLASSIFIED SECTION

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

age	dose
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 - 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

INGREDIENTS AND APPEARANCE

PRIMATENE 
ephedrine hcl, guaifenesin tablet

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 0573-2952
Route of Administration	ORAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
EPHEDRINE HYDROCHLORIDE (UNII: NLJ6390P1Z) (EPHEDRINE - UNII:GN83C131XS)	EPHEDRINE HYDROCHLORIDE	12.5 mg
GUAIFENESIN (UNII: 495W7451VQ) (GUAIFENESIN - UNII:495W7451VQ)	GUAIFENESIN	200 mg

Inactive Ingredients
Ingredient Name	Strength
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
Color	YELLOW (Light yellow color)	Score	no score
Shape	ROUND	Size	8mm
Flavor		Imprint Code	P;in;circle;engraved;bisect
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 0573-2952-10	2 in 1 CARTON	01/06/2004
1		12 in 1 BLISTER PACK; Type 0: Not a Combination Product
2	NDC: 0573-2952-20	5 in 1 CARTON	01/06/2004
2		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	01/06/2004

Labeler - Wyeth Consumer Healthcare LLC (828831730)

Establishment
Name	Address	ID/FEI	Business Operations
Wyeth Pharmaceuticals Company		829390975	ANALYSIS(0573-2952) , LABEL(0573-2952) , MANUFACTURE(0573-2952) , PACK(0573-2952)