Other
DAYTIME SEVERE COLD AND FLU RELIEF
Drug Facts
NIGHTTIME SEVERE COLD AND FLU RELIEF
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/nighttime (NDC 36800-746). 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.
DAYTIME SEVERE COLD AND FLU RELIEF
Drug Facts
NIGHTTIME SEVERE COLD AND FLU RELIEF
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 |
| 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 |
This product contains acetaminophen. Severe liver damage may occur if you take
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.
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.
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.
These could be signs of a serious condition.
If pregnant or breast-feeding, ask a health professional before use.
If pregnant or breast-feeding, ask a health professional before use.
In case of overdose, get medical help or contact a Poison Control Center right away.
In case of overdose, get medical help or contact a Poison Control Center right away.
| adults & children 12 yrs and over | 2 softgels with water every 4 hrs |
| children 4 to under 12 yrs | ask a doctor |
| children under 4 yrs | do not use |
| adults & children 12 yrs and over | 2 softgels with water every 4 hrs |
| 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
D&C yellow #10, FD&C blue #1, gelatin, glycerin, polyethylene glycol, povidone K30, propylene glycol, purified water, sodium hydroxide, sorbitol sorbitan solution, titanium dioxide
1-888-423-0139
1-888-423-0139
NDC 36800-829-24
*Compare to the active ingredients
in Vicks® DayQuil™ Severe
MULTI-SYMPTOM RELIEF
DayTime
Cold & Flu Relief
SEVERE
Acetaminophen - Pain reliever/Fever reducer
Dextromethorphan HBr - Cough suppressant
Guaifenesin - Expectorant
Phenylephrine HCl - Nasal decongestant
Non-drowsy
Alcohol free
Antihistamine free
actual size
12 SOFTGELS
*Compare to the active ingredients
in Vicks® NyQuil™ Severe
MULTI-SYMPTOM RELIEF
NightTime
Cold & Flu Relief
SEVERE
Acetaminophen - Pain reliever/Fever reducer
Dextromethorphan HBr - Cough suppressant
Doxylamine succinate - Antihistamine
Phenylephrine HCl - Nasal decongestant
actual size
12 SOFTGELS
TOTAL 24
SOFTGELS
* Please review the disclaimer below.