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Drug Facts
The following Structured Product Label (SPL) was submitted to the FDA by Spirit Pharmaceuticals Llc for the product Multi-symptom Daytime (NDC 68210-4149). 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:, sore throat warning:, otc - 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 hydrobromide 10 mg................Cough suppressant
Phenylephrine hydrochloride 5 mg.........................Nasal decongestant
temporarily relieves common cold/flu symptoms:
This product contains acetaminophen. Severe liver
damage may occur if you take
■ more than 10 softgels in 24 hours, which is the maximum daily
amount for this product
■ with other drugs containing acetaminophen
■ 3 or more alcoholic drinks every day while using this product
acetaminophen may cause severe skin reactions. Symptoms may include:
If sore throat is severe, lasts for more than 2 days, occurs with or is followed by fever, headache, rash, nausea, or vomiting, see a doctor promptly.
Do not use:
Ask a doctor or pharmacist before use if you are taking the blood-thinning drug Warfarin.
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 overdose, get medical help or contact a Poison Control Center right away. Quick medical attention is critical for adults and for children, even if you do not notice any signs or symptoms.
■ do not take more than the recommended dose
■ adults and children 12 years and over: take 2 softgels with water
every 4 hours. Do not exceed 10 softgels in 24 hours or as directed
by a doctor.
■ children under 12 years: do not use
FD&C Red No. 40, FD&C Yellow No.6. gelatin, glycerin, polyethylene glycol 400, povidone, propylene glycol, purified water, sorbitol sorbitan, titanium dioxide
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