Nighttime Severe Cold & Fluactive Ingredients (In Each 30 Ml)
Acetaminophen 650 mg
Dextromethorphan HBr 20 mg
Doxylamine succinate 12.5 mg
Phenylephrine HCl 10 mg
The following Structured Product Label (SPL) was submitted to the FDA by Cvs Pharmacy for the product Severe Daytime (NDC 59779-603). 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 nighttime severe cold & fluactive ingredients (in each 30 ml), purpose, uses, warnings, do not use, ask a doctor before use if you have, ask a doctor or pharmacist before use if you are, when using this product, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Acetaminophen 650 mg
Dextromethorphan HBr 20 mg
Doxylamine succinate 12.5 mg
Phenylephrine HCl 10 mg
Pain reliever/fever reducer
Cough suppressant
Antihistamine
Nasal decongestant
Pain reliever/fever reducer
Cough suppressant
Expectorant
Nasal decongestant
temporarily relieves common cold/flu symptoms:
temporarily relieves common cold/flu symptoms:
Liver warning: This product contains acetaminophen. Severe liver damage may occur if you take
Allergy alert: Acetaminophen may cause severe skin reactions. Symptoms may include:
If a skin reaction occurs, stop use and seek medical help right away.
Sore throat warning: 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.
Liver warning: This product contains acetaminophen. Severe liver damage may occur if
Allergy alert: Acetaminophen may cause severe skin reactions. Symptoms may include:
If a skin reaction occurs, stop use and seek medical help right away.
Sore throat warning: 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.
taking the blood thinning drug warfarin
do not use more than directed
ask a health professional before use.
ask a health professional before use.
Overdose warning: In case of overdose, get medical help or contact a Poison Control Center right away (1-800-222-1222). Quick medical attention is critical for adults as well as for children even if you do not notice any signs or symptoms.
Overdose warning: In case of overdose, get medical help or contact a Poison Control Center right away (1-800-222-1222). 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 yrs & over | 30 mL every 4 hrs |
children 4 to under 12 yrs | ask a doctor |
children under 4 yrs | do not use |
adults & children 12 yrs & over | 30 mL every 4 hrs |
children 6 to under 12 yrs | 15 mL every 4 hrs |
children 4 to under 6 yrs | ask a doctor |
children under 4 yrs | do not use |
butylated hydroxyanisole, edetate disodium, FD&C blue #1, FD&C red #40, flavor, glycerin, monobasic sodium phosphate, polyethylene glycol, propylene glycol, purified water, saccharin sodium, sucrose, xanthan gum
butylated hydroxyanisole, edetate disodium, FD&C yellow #6, flavor, glycerin, menthol, monobasic sodium phosphate, polyethylene glycol, propylene glycol, purified water, saccharin sodium, sucrose, xanthan gum
1-800-719-9260
1-800-719-9260
Acetaminophen 325 mg
Dextromethorphan HBr 10 mg
Guaifenesin 200 mg
Phenylephrine HCl 5 mg
TWIN PACK
Compare to the active ingredients in Vicks® DayQuil® Severe
Severe
Non-Drowsy
Daytime
COLD & FLU RELIEF
ACETAMINOPHEN – Pain reliever; Fever reducer
DEXTROMETHORPHAN HBr – Cough suppressant
GUAIFENESIN – Expectorant
PHENYLEPHRINE HCl – Nasal decongestant
MAXIMUM STRENGTH
Relieves:
Aches; Fever; Cough; Nasal congestion; Sore throat; Chest congestion
Alcohol free
Antihistamine free
See New Warnings
TOTAL 24 FL OZ (1.5 PT) (710 mL)
TWIN PACK
Compare to the active ingredients in Vicks® NyQuil® Severe
Severe
Nighttime
COLD & FLU RELIEF
ACETAMINOPHEN – Pain reliever; Fever reducer
DEXTROMETHORPHAN HBr – Cough suppressant
DOXYLAMINE SUCCINATE – Antihistamine
PHENYLEPHRINE HCl – Nasal decongestant
MAXIMUM STRENGTH
Relieves:
Aches; Fever; Sore throat; Cough; Sneezing; Runny nose; Nasal/sinus congestion & Sinus pressure
Berry Flavor
Alcohol free
See New Warnings
TWO 12 FL OZ (355 mL) UNITS
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