Sudafed PE Head Congestion + Flu Severe Tablets (24 ct.) temporarily relieve cold and flu symptoms, including sinus pressure, headache, sore throat, cough, and chest congestion without causing drowsiness.
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Sudafed PE Sinus Head Congestion + Flu Severe Non-Drowsy Tablets, 24 ct.
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This product is FSA eligible
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Sudafed PE Head Congestion + Flu Severe Tablets (24 ct.) give temporary, non-drowsy relief from coughing, nasal congestion, sore throat, sinus pressure, headache, and minor aches and pains, plus helps loosen phlegm (mucus) and thin bronchial secretions to drain bronchial tubes and make coughs more productive. Take your health to the next level with guaranteed FSA eligible Over-the-Counter Meds.
Each tablet contains:
- 325mg of Acetaminophen , a pain reliever and fever reducer;
- 5mg of phenylephrine HCl, a nasal decongestant
- 100mg of guaifenesin, an expectorant
- 10mg of dextromethorphan HBr, a cough suppressant
- These tablets can be used by adults and children 12 years and over
These tablets can be used by adults and children 12 years and over for temporary, non-drowsy relief from coughing, nasal congestion, sore throat, sinus pressure, headache, and minor aches and pains--plus help loosening phlegm (mucus) and thinning bronchial secretions to drain bronchial tubes and make coughs more productive.
These tablets can be used by adults and children 12 years and over for temporary, non-drowsy relief from coughing, nasal congestion, sore throat, sinus pressure, headache, and minor aches and pains--plus help loosening phlegm (mucus) and thinning bronchial secretions to drain bronchial tubes and make coughs more productive.
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See also Warning section.
Drug interactions may change how your medications work or increase your risk for serious side effects. This document does not contain all possible drug interactions. Keep a list of all the products you use (including prescription/nonprescription drugs and herbal products) and share it with your doctor and pharmacist. Do not start, stop, or change the dosage of any medicines without your doctor's approval.
Taking certain MAO inhibitors with this medication may cause a serious (possibly fatal) drug interaction. Avoid taking isocarboxazid, metaxalone, methylene blue, moclobemide, phenelzine, procarbazine, rasagiline, safinamide, selegiline, or tranylcypromine during treatment with this medication. Most MAO inhibitors should also not be taken for two weeks before treatment with this medication. Ask your doctor when to start or stop taking this medication.
Some products that may interact with this drug are: beta blockers (such as metoprolol, atenolol), guanethidine, ketoconazole, levoketoconazole, methyldopa, rolapitant, tricyclic antidepressants (such as amitriptyline, desipramine).
The ingredients in this product are available in many prescription and nonprescription products. Check the labels on all your medications carefully to make sure you are not taking more than one product with the same ingredient(s). Consult your pharmacist if you are unsure of the ingredients in any of your medications.
Tell your doctor or pharmacist if you are taking other products that cause drowsiness such as opioid pain or cough relievers (such as codeine, hydrocodone), alcohol, marijuana (cannabis), drugs for sleep or anxiety (such as alprazolam, lorazepam, zolpidem), muscle relaxants (such as carisoprodol, cyclobenzaprine), or antihistamines (such as cetirizine, diphenhydramine).
Check the labels on all your medicines (such as allergy or cough-and-cold products) because they may contain ingredients that cause drowsiness. Ask your pharmacist about using those products safely.
Some products have ingredients that could raise your heart rate or blood pressure. Tell your pharmacist what products you are using, and ask how to use them safely (especially cough-and-cold products or diet aids).
This medication may interfere with certain urine lab tests (such as 5-HIAA levels, VMA levels), possibly causing false test results. Make sure lab personnel and all your doctors know you use this drug.
Does Sudafed PE Head Congestion-Flu 5 Mg-10 Mg-325 Mg-100 Mg Tablet Expectorants interact with other drugs you are taking?
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SUDAFED PE HEAD CONGESTION PLUS FLU SEVERE- acetaminophen, dextromethorphan hydrobromide, guaifenesin, and phenylephrine hydrochloride tablet, film coated
Johnson & Johnson Consumer Inc., McNeil Consumer Healthcare Division
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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Acetaminophen 325 mg | Pain reliever/fever reducer |
Dextromethorphan HBr 10 mg | Cough suppressant |
Guaifenesin 100 mg | Expectorant |
Phenylephrine HCl 5 mg | Nasal decongestant |
Uses
- temporarily relieves these symptoms due to the common cold:
- nasal congestion
- headache
- minor aches and pains
- cough
- sore throat
- sinus congestion and pressure
- helps loosen phlegm (mucus) and thin bronchial secretions to drain bronchial tubes and make coughs more productive
- temporarily reduces fever
Warnings
Liver warning
This product contains acetaminophen. The maximum daily dose of this product is 10 tablets (3,250 mg acetaminophen) in 24 hours. Severe liver damage may occur if you take
- more than 4,000 mg of acetaminophen in 24 hours
- with other drugs containing acetaminophen
- 3 or more alcoholic drinks every day while using this product
Allergy alert: acetaminophen may cause severe skin reactions. Symptoms may include:
- skin reddening
- blisters
- rash
If a skin reaction occurs, stop use and seek medical help right away.
Sore throat warning
If sore throat is severe, persists for more than 2 days, is accompanied or followed by fever, headache, rash, nausea, or vomiting, consult a doctor promptly.
Do not use
- with any other drug containing acetaminophen (prescription or nonprescription). If you are not sure whether a drug contains acetaminophen, ask a doctor or pharmacist.
- if you are now taking a prescription monoamine oxidase inhibitor (MAOI) (certain drugs 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.
- if you have ever had an allergic reaction to this product or any of its ingredients
Ask a doctor before use if you have
- liver disease
- heart disease
- high blood pressure
- thyroid disease
- diabetes
- trouble urinating due to an enlarged prostate gland
- persistent or chronic cough such as occurs with smoking, asthma, chronic bronchitis, or emphysema
- cough that occurs with too much phlegm (mucus)
Ask a doctor or pharmacist before use if you are taking the blood thinning drug warfarin
When using this product do not exceed recommended dose
Stop use and ask a doctor if
- nervousness, dizziness, or sleeplessness occur
- pain, cough or nasal congestion gets worse or lasts more than 7 days
- fever gets worse or lasts more than 3 days
- redness or swelling is present
- new symptoms occur
- cough comes back or occurs with rash or headache that lasts
These could be signs of a serious condition.
If pregnant or breast-feeding, ask a health professional before use.
Keep out of reach of children.
Overdose warning
In case of overdose, get medical help or contact a Poison Control Center right away. (1-800-222-1222) Quick medical attention is critical for adults as well as for children even if you do not notice any signs or symptoms.
Directions
- do not use more than directed (see overdose warning)
adults and children 12 years and over |
|
children under 12 years | ask a doctor |
Other information
- contains FD&C yellow no. 5 aluminum lake (tartrazine) as a color additive
- store between 20-25°C (68-77°F)
- do not use if carton or blister unit is opened or broken
Inactive ingredients
carnauba wax, croscarmellose sodium, FD&C yellow no. 5 aluminum lake (tartrazine), FD&C yellow no. 6 aluminum lake, hydroxypropyl cellulose, hypromellose, magnesium stearate, microcrystalline cellulose, polyethylene glycol, polysorbate 80, pregelatinized starch, titanium dioxide
Questions or comments?
call 1-888-217-2117 (toll-free) or 215-273-8755 (collect)
PRINCIPAL DISPLAY PANEL
PREVIOUSLY SUDAFED PE ® PRESSURE + PAIN + COLD
NDC 50580-450-01
SUDAFED PE®
HEAD CONGESTION
+ FLU SEVERE
Acetaminophen, Dextromethorphan HBr, Guaifenesin,
Phenylephrine HCl, Pain Reliever/Fever Reducer,
Cough Suppressant, Expectorant, Nasal Decongestant
actual
size
- SINUS PRESSURE
- HEADACHE
- SORE THROAT
- COUGH
- CHEST CONGESTION
24 TABLETS
NON-DROWSY