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Drug Facts
The following Structured Product Label (SPL) was submitted to the FDA by Humanwell Puracap Pharmaceuticals (wuhan) Co., Ltd for the product Daytime Cold And Flu (NDC 53345-056). 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, liver warning, allergy alert, sore throat warning, do not use, 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
Temporarily relieves common cold/flu symptoms:
This product contains acetaminophen. Severe liver damage may occur if you take
Acetaminophen may cause severe skin reactions. Symptoms may include:
If a skin reaction occurs, stop use and seek medical help right away
If sore throat is severe, lasts for more than 2 days, is accompanied or followed by fever, headache, rash, nausea, or vomiting, consult a doctor promptly.
When using this product do not exceed recommended dose.
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.
In case of accidental overdose, seek professional assistance or contact a Poison Control Center immediately.
Prompt medical attention is critical for adults as well as for children even if you do not notice any signs or symptoms.
| adults and children 12 years and over | 2 softgels with water every 4 hours |
| children 4 to under 12 years | consult a doctor |
| children under 4 years | do not use |
FD&C Red # 40, FD&C Yellow # 6, Gelatin, Glycerin, Polyethylene Glycol 400, Povidone K12, Propylene Glycol, Purified water, Sorbitol Sorbitan Solution, White ink.
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