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Drug Facts
The following Structured Product Label (SPL) was submitted to the FDA by R J General Corporation for the product Alka-seltzer Plus Severe Cold And Flu Powerfast Fizz (NDC 70264-016). 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 - purpose, uses, liver warning:, allergy alert:, otc - do not use, ask a doctor before use if you have, ask a doctor or pharmacist before use if you are, 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 250 mg | Pain reliever/fever reducer |
| Chlorpheniramine maleate 2 mg | Antihistamine |
| Dextromethorphan hydrobromide 10 mg | Cough suppressant |
| Phenylephrine hydrochloride 5 mg | Nasal decongestant |
This product contains acetaminophen. Severe liver damage may occur if you take
Acetaminophen may cause severe skin or severe allergic reactions. Symptoms may include:
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
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.
anhydrous citric acid, calcium silicate, dimethicone, FDC red #40, FDC yellow #6, flavors, magnesium stearate, maltodextrin, mannitol, potassium bicarbonate, povioone, sodium bicarbonate, sucralose.
Alka-
Seltzer
PLUS
®
Acetaminophen / Pain reliever/fever reducer
Chlorpheniramine maleate / Antihistamine
Dextromethorphan hydrobromide / Cough suppressant
Phenylephrine hydrochloride / Nasal decongestant
COLD
FORMULA
SPARKLING
ORIGINAL
Nasal Congestion • Runny Nose
Headache & Body Ache
Sore Throat • Sinus Pressure
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