PRIMATENE
Dosage form: tablet
Ingredients: EPHEDRINE HYDROCHLORIDE 12.5mg, GUAIFENESIN 200mg
Labeler: Pfizer Consumer Healthcare
NDC Code: 0573-2952
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.
DRUG FACTS
Ephedrine HCl, USP 12.5 mg
Guaifenesin, USP 200 mg
Bronchodilator
Expectorant
- 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
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
- 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.
- 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
- 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)
- 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.
- 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.
- 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 |
- store at 20-25°C (68-77°F)
colloidal silicon dioxide, crospovidone, D&C yellow no. 10 aluminum lake, FD&C yellow no. 6 aluminum lake, magnesium stearate, microcrystalline cellulose, povidone
Call weekdays from 9 AM to 5 PM EST at 1-800-535-0026
For most recent product information, visit www.PrimateneTablets.com
Primatene®
TABLETS
Ephedrine HCl, Bronchodilator/Guaifenesin, Expectorant
Helps Loosen Phlegm (Mucus)
For the Temporary Relief of Mild Symptoms of
INTERMITTENT ASTHMA
60 TABLETS
| PRIMATENE
ephedrine hcl, guaifenesin tablet |
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| Labeler - Pfizer Consumer Healthcare (828831730) |
| Establishment | |||
| Name | Address | ID/FEI | Operations |
| Wyeth Pharmaceuticals Company, Consumer Site | 829390975 | ANALYSIS(0573-2952), LABEL(0573-2952), MANUFACTURE(0573-2952), PACK(0573-2952) | |
Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date, and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or drug combination in no way should be construed to indicate that the drug or drug combination is safe, effective or appropriate for any given patient. If you have questions about the drugs you are taking, check with your doctor, nurse or pharmacist.
