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Drug Facts
Dist. by: Bayer HealthCare LLC
Whippany, NJ 07981
The following Structured Product Label (SPL) was submitted to the FDA by Bayer Healthcare Llc. for the product Alka Seltzer Cold Cold Flu And Congestion Severe Fast Hot Liquid Day (NDC 0280-8273). 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, warnings, liver warning, sore throat warning, do not use, ask a doctor before use if you have, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Drug Facts
Dist. by: Bayer HealthCare LLC
Whippany, NJ 07981
| Active ingredients (in each packet) | Purposes |
|---|---|
| Acetaminophen 500 mg | Pain reliever/fever reducer |
| Dextromethorphan hydrobromide 20 mg | Cough suppressant |
| Guaifenesin 400 mg | Expectorant |
| Phenylephrine hydrochloride 10 mg | Nasal decongestant |
.
This product contains acetaminophen. Severe liver damage may occur if you take
Allergy alert: 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.
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.
Ask a doctor or pharmacist before use if you are taking the blood thinning drug warfarin
When using this product do not exceed recommended dosage
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.
acesulfame potassium, anhydrous citric acid, compressible sugar, D&C yellow #10, dental-type silica, FD&C red #40, flavors, maltodextrin, povidone, pregelatinized starch, silicon dioxide, sodium citrate, stearic acid, sucralose, tartaric acid, tribasic calcium phosphate
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