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Drug Facts
The following Structured Product Label (SPL) was submitted to the FDA by Topco Associates Llc for the product Cold And Flu Severe Daytime (NDC 36800-986). 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, 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 |
| Guaifenesin 200 mg | Expectorant |
| Phenylephrine HCl 5 mg | Nasal decongestant |
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, 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; taking sedatives or tranquilizers.
When using this product, do not use more than directed.
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.
| adults & children 12 yrs & over | 2 softgels with water every 4 hours |
| children 4 to under 12 yrs | ask a doctor |
| children under 4 yrs | do not use |
FD&C yellow #6, gelatin, glycerin, polyethylene glycol, povidone K30, propylene glycol, purified water, sorbitol sorbitan solution, titanium dioxide
Call toll free: 1-888-423-0139
NDC: 36800-826-24
*Compare to the active ingredients
in Vicks® Dayquil™ Severe Cold & Flu
MULTI-SYMPTOM RELIEF
Day Time
Cold & Flu Relief
SEVERE
PAIN RELIEVER-FEVER REDUCER - ACETAMINOPHEN
COUGH SUPPRESSANT - DEXTROMETHORPHAN HBr
EXPECTORANT - GUAIFENESIN
NASAL DECONGESTANT - PHENYLEPHRINE HCl
• Headache, Fever, Sore Throat, Minor Aches & Pains
• Sinus Congestion & Pressure
• Nasal Congestion • Cough
Alcohol Free
Antihistamine Free
Non-Drowsy
24 SOFTGELS
actual size
* Please review the disclaimer below.