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Drug Facts
The following Structured Product Label (SPL) was submitted to the FDA by Puracap Pharmaceutical Llc for the product Ultra Concentrated Daytime Cold And Flu (NDC 51013-667). 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, active ingredients (in each softgel), purpose, uses, warnings, do not use, ask a doctor before use if you have, otc - ask doctor/pharmacist, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Drug Facts
Acetaminophen 325 mg
Dextromethorphan HBr 10 mg
Pain reliever/fever reducer
Cough suppressant
Liver warning
This product contains acetaminophen. Severe liver damage may occur if you take
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.
Allergy alert:Acetaminophen may cause severe skin reactions. Symptoms may include:
If a skin reaction occurs, stop use and seek medical help right away.
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.
FD&C red #40, FD&C yellow #6, gelatin, glycerin, polyethylene glycol, povidone, propylene glycol, purified water, sorbitol special, white edible ink
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