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Drug Facts
The following Structured Product Label (SPL) was submitted to the FDA by Bayer Healthcare Llc. for the product Alka-seltzer Plus Maximum Strength Sinus Congestion And Pain Powerfast Fizz (NDC 0280-0055). This document serves as the official prescribing information, containing essential scientific data and clinical materials required for healthcare providers and patients.
This specific version of the label includes detailed information regarding other, otc - active ingredient, uses, warnings, otc - do not use, otc - ask doctor/pharmacist, otc - when using, otc - stop use, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Drug Facts
Active ingredients (in each tablet) Purposes
Acetaminophen 325 mg…………….………...Pain reliever/fever reducer
Chlorpheniramine maleate 2 mg……………………..……..Antihistamine
Dextromethorphan hydrobromide 10 mg……………Cough suppressant
Phenylephrine hydrochloride 5 mg………………….Nasal decongestant
temporarily relieves these symptoms due to a cold or flu:
temporarily reduces fever
Liver warning: This product contains acetaminophen. 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 or severe
allergic reactions. Symptoms may include:
· skin reddening · blisters · rash · hives
· facial swelling · asthma (wheezing) · shock
If a skin or general allergic 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 to sedate children.
Do not use
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 or pharmacist before use if you are
When using this product
Stop use and ask a doctor if
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. Quick medical attention is critical for adults as well as for children even if you do not notice any signs or symptoms.
Directions
Other information
each tablet contains: potassium 78 mg; sodium 356 mg
store at room temperature. Avoid excessive heat.
Inactive ingredients anhydrous citric acid, calcium silicate, dimethicone, flavors, magnesium stearate, maltodextrin, mannitol, potassium bicarbonate, povidone, sodium bicarbonate, sucralose
Questions or comments? 1-800-986-0369 (Mon-Fri 9AM - 5PM EST)
Alka-Seltzer Plus®
MAXIMUM STRENGTH
Sinus
Congestion
& Pain
PowerFast Fizz™
Berry
New!
Actaminophen/Pain Reliever-Fever Reducer
Chlorpheniramine Maleate/Antihistamine
Dextromethorphan HBr/Cough Supressant
Phenylephrine Hydrochloride/Nasal Decongestant
20 EFFERVESCENT TABLETS
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