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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ACTIVE INGREDIENTS (IN EACH TABLET)
Ephedrine HCl, USP 12.5 mg
Guaifenesin, USP 200 mg
PURPOSES
Bronchodilator
Expectorant
USES
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- for temporary relief of mild symptoms of intermittent asthma:
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- wheezing
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- tightness of chest
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- shortness of breath
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- 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
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- are not better in 60 minutes
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- get worse
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- need more than 12 tablets in 24 hours
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- use more than 8 tablets in 24 hours for 3 or more days a week
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- have more than 2 asthma attacks in a week
These may be signs that your asthma is getting worse
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- This product will not give you asthma relief as quickly as an inhaled bronchodilator
Do not use
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- unless a doctor said you have asthma
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- 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
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- ever been hospitalized for asthma
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- heart disease
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- high blood pressure
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- diabetes
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- thyroid disease
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- seizures
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- narrow angle glaucoma
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- a psychiatric or emotional condition
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- trouble urinating due to an enlarged prostate gland
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- cough that occurs with too much phlegm (mucus)
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- 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
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- taking prescription drugs for asthma, obesity, weight control, depression, or psychiatric or emotional conditions
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- 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
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- your asthma is getting worse (see Asthma alert)
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- you have difficulty sleeping
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- you have a rapid heart beat
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- you have tremors, nervousness, or seizure
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- 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
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-
your blood pressure or heart rate may go up. This could increase your risk of heart attack or stroke, which may cause death.
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-
your risk of heart attack or stroke increases if you:
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-
have a history of high blood pressure or heart disease
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-
take this product more frequently or take more than the recommended dose
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- avoid foods or beverages that contain caffeine
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- 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
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- 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