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Drug Facts
The following Structured Product Label (SPL) was submitted to the FDA by Spirit Pharmaceuticals Llc for the product Severe Nighttime Cold And Flu (NDC 68210-4087). 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, sore throat warning, allergy alert, 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
| Active ingredients (in each softgel) | Purposes |
|---|---|
| Acetaminophen 325 mg | Pain reliever/fever reducer |
| Dextromethorphan HBr 10 mg | Cough suppressant |
| Doxylamine succinate 6.25 mg | Antihistamine |
| Phenylephrine HCl 5 mg | Nasal decongestant |
temporarily relieves common cold/flu symptoms:
This product contains acetaminophen. Severe liver damage may occur if you take
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.
Acetaminophen may cause severe skin reactions. Symptoms may include:
If a skin reaction occurs, stop use and seek medical help right away.
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.
Taking more than directed can cause serious health problems. 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.
| adults & children 12 years & over | 2 softgels with water every 4 hours |
| children 4 to under 12 years | ask a doctor |
| children under 4 years | do not use |
D&C Yellow No. 10, FD&C Blue No. 1, gelatin, glycerin, polyethylene glycol 400, povidone K30, propylene glycol, purified water, shellac, sorbitol sorbitan, sodium hydroxide, titanium dioxide
Compare to Vicks® NyQuil® Severe
Cold & Flu active ingredients
NIGHTTIME
Severe Cold & Flu
ACETAMINOPHEN/ PAIN RELIEVER/ FEVER REDUCER
DEXTROMETHORPHAN HBR/ COUGH SUPPRESSANT
DOXYLAMINE SUCCINATE/ ANTIHISTAMINE
PHENYLEPHRINE HCL/ NASAL DECONGESTANT
MAXIMUM STRENGTH
48
SOFTGELS
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