Severe Nighttime Cold & Flu Relief
484fb43b-8a97-4725-9ea7-aa56fb3610bc
34390-5
HUMAN OTC DRUG LABEL
Drug Facts
Composition & Product
Identifiers & Packaging
Description
Drug Facts Active ingredients (in each 30 mL)
Medication Information
Description
Drug Facts Active ingredients (in each 30 mL)
Uses
temporarily relieves common cold/flu symptoms:
-
•nasal congestion
-
•sinus congestion & pressure
-
•cough due to minor throat & bronchial irritation
-
•cough to help you sleep
-
•minor aches & pains
-
•headache
-
•fever
-
•sore throat
-
•runny nose & sneezing
-
•reduces swelling of nasal passages
-
•temporarily restores freer breathing through the nose
-
•promotes nasal and/or sinus drainage
Section 42229-5
Drug Facts
Active ingredients (in each 30 mL)
Section 50565-1
Keep out of reach of children.
Section 53414-9
If pregnant or breast-feeding, ask a health professional before use.
Section 55105-1
Pain reliever/fever reducer
Cough suppressant
Antihistamine
Nasal decongestant
Section 55106-9
Acetaminophen 650 mg
Dextromethorphan HBr 20 mg
Doxylamine succinate 12.5 mg
Phenylephrine HCl 10 mg
Directions
-
•take only as directed
-
•only use the dose cup provided
-
•do not exceed 4 doses per 24 hrs
|
adults & children 12 yrs & over |
30 mL every 4 hrs |
|
children 4 to under 12 yrs |
ask a doctor |
|
children under 4 years |
do not use |
Do Not Use
-
•with any other drug containing acetaminophen (prescription or nonprescription). If you are not sure whether a drug contains acetaminophen, ask a doctor or pharmacist.
-
•if you are now taking a prescription monoamine oxidase inhibitor (MAOI) (certain drugs for depression, psychiatric or emotional conditions, or Parkinson's disease), or for 2 weeks after stopping the MAOI drug. If you do not know if your prescription drug contains an MAOI, ask a doctor or pharmacist before taking this product.
Questions?
1-866-467-2748
Liver Warning
This product contains acetaminophen. Severe liver damage may occur if you take
-
•more than 4 doses 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
Allergy Alert:
Acetaminophen may cause severe skin reactions. Symptoms may include:
-
•Skin reddening
-
•Blisters
-
•Rash
If a skin reaction occurs, stop use and seek medical help right away
Other Information
-
•each 30 mL contains: sodium 77 mg
-
•Store at room temperature.
-
•Do not refrigerate.
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.
Inactive Ingredients
Anhydrous citric acid, disodium edetate, FD&C Red No. 40, FD&C Blue No. 1, flavors, glycerin, propylene glycol, propyl gallate, purified water, sodium benzoate, sodium chloride, sodium citrate dihydrate, sorbitol, sucralose, xanthan gum.
When Using This Product
-
•do not use more than directed
-
•excitability may occur, especially in children
-
•marked drowsiness may occur
-
•avoid alcoholic drinks
-
•be careful when driving a motor vehicle or operating machinery
-
•alcohol, sedatives, and tranquilizers may increase drowsiness
Stop Use and Ask A Doctor If
-
•you get nervous, dizzy or sleepless
-
•pain, nasal congestion, or cough gets worse or lasts more than 7 days
-
•fever gets worse or lasts more than 3 days
-
•redness or swelling is present
-
•new symptoms occur
-
•cough comes back or occurs with rash or headache that lasts.
These could be signs of a serious condition.
Ask A Doctor Before Use If You Have
-
•liver disease
-
•heart disease
-
•high blood pressure
-
•thyroid disease
-
•diabetes
-
•glaucoma
-
•cough that occurs with too much phlegm (mucus)
-
•a breathing problem or chronic cough that lasts or as occurs with smoking, asthma, chronic bronchitis, or emphysema
-
•trouble urinating due to enlarged prostate gland
-
•a sodium-restricted diet
Principal Display Panel 354ml Bottle Label
*Compare to the active ingredients inVICKS® NyQuil™ Severe Cold & Flu
NDC 55319-681-08
Severe
NightTime
Cold & Flu
Relief
Acetaminophen- Pain reliever/Fever reducer
Phenylephrine HCl – Nasal decongestant
Doxylamine Succinate - Antihistamine
Dextromethorphan HBr – Cough suppressant
-
•Headache, Fever, Sore Throat,
Minor Aches & Pains
-
•Nasal Congestion & Sinus Pressure
-
•Sneezing, Runny Nose
-
•Cough
Mixed Berry Flavor
Naturally and Artificially Flavored
8 FL OZ (236 ml)
Ask A Doctor Or Pharmacist Before Use If You Are
-
•taking sedatives or tranquilizers
-
•taking the blood thinning drug warfarin
Structured Label Content
Uses
temporarily relieves common cold/flu symptoms:
-
•nasal congestion
-
•sinus congestion & pressure
-
•cough due to minor throat & bronchial irritation
-
•cough to help you sleep
-
•minor aches & pains
-
•headache
-
•fever
-
•sore throat
-
•runny nose & sneezing
-
•reduces swelling of nasal passages
-
•temporarily restores freer breathing through the nose
-
•promotes nasal and/or sinus drainage
Section 42229-5 (42229-5)
Drug Facts
Active ingredients (in each 30 mL)
Section 50565-1 (50565-1)
Keep out of reach of children.
Section 53414-9 (53414-9)
If pregnant or breast-feeding, ask a health professional before use.
Section 55105-1 (55105-1)
Pain reliever/fever reducer
Cough suppressant
Antihistamine
Nasal decongestant
Section 55106-9 (55106-9)
Acetaminophen 650 mg
Dextromethorphan HBr 20 mg
Doxylamine succinate 12.5 mg
Phenylephrine HCl 10 mg
Directions
-
•take only as directed
-
•only use the dose cup provided
-
•do not exceed 4 doses per 24 hrs
|
adults & children 12 yrs & over |
30 mL every 4 hrs |
|
children 4 to under 12 yrs |
ask a doctor |
|
children under 4 years |
do not use |
Do Not Use (Do not use)
-
•with any other drug containing acetaminophen (prescription or nonprescription). If you are not sure whether a drug contains acetaminophen, ask a doctor or pharmacist.
-
•if you are now taking a prescription monoamine oxidase inhibitor (MAOI) (certain drugs for depression, psychiatric or emotional conditions, or Parkinson's disease), or for 2 weeks after stopping the MAOI drug. If you do not know if your prescription drug contains an MAOI, ask a doctor or pharmacist before taking this product.
Questions?
1-866-467-2748
Liver Warning (Liver warning)
This product contains acetaminophen. Severe liver damage may occur if you take
-
•more than 4 doses 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
Allergy Alert:
Acetaminophen may cause severe skin reactions. Symptoms may include:
-
•Skin reddening
-
•Blisters
-
•Rash
If a skin reaction occurs, stop use and seek medical help right away
Other Information (Other information)
-
•each 30 mL contains: sodium 77 mg
-
•Store at room temperature.
-
•Do not refrigerate.
Sore Throat Warning (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.
Inactive Ingredients (Inactive ingredients)
Anhydrous citric acid, disodium edetate, FD&C Red No. 40, FD&C Blue No. 1, flavors, glycerin, propylene glycol, propyl gallate, purified water, sodium benzoate, sodium chloride, sodium citrate dihydrate, sorbitol, sucralose, xanthan gum.
When Using This Product (When using this product)
-
•do not use more than directed
-
•excitability may occur, especially in children
-
•marked drowsiness may occur
-
•avoid alcoholic drinks
-
•be careful when driving a motor vehicle or operating machinery
-
•alcohol, sedatives, and tranquilizers may increase drowsiness
Stop Use and Ask A Doctor If (Stop use and ask a doctor if)
-
•you get nervous, dizzy or sleepless
-
•pain, nasal congestion, or cough gets worse or lasts more than 7 days
-
•fever gets worse or lasts more than 3 days
-
•redness or swelling is present
-
•new symptoms occur
-
•cough comes back or occurs with rash or headache that lasts.
These could be signs of a serious condition.
Ask A Doctor Before Use If You Have (Ask a doctor before use if you have)
-
•liver disease
-
•heart disease
-
•high blood pressure
-
•thyroid disease
-
•diabetes
-
•glaucoma
-
•cough that occurs with too much phlegm (mucus)
-
•a breathing problem or chronic cough that lasts or as occurs with smoking, asthma, chronic bronchitis, or emphysema
-
•trouble urinating due to enlarged prostate gland
-
•a sodium-restricted diet
Principal Display Panel 354ml Bottle Label (PRINCIPAL DISPLAY PANEL - 354mL Bottle Label)
*Compare to the active ingredients inVICKS® NyQuil™ Severe Cold & Flu
NDC 55319-681-08
Severe
NightTime
Cold & Flu
Relief
Acetaminophen- Pain reliever/Fever reducer
Phenylephrine HCl – Nasal decongestant
Doxylamine Succinate - Antihistamine
Dextromethorphan HBr – Cough suppressant
-
•Headache, Fever, Sore Throat,
Minor Aches & Pains
-
•Nasal Congestion & Sinus Pressure
-
•Sneezing, Runny Nose
-
•Cough
Mixed Berry Flavor
Naturally and Artificially Flavored
8 FL OZ (236 ml)
Ask A Doctor Or Pharmacist Before Use If You Are (Ask a doctor or pharmacist before use if you are)
-
•taking sedatives or tranquilizers
-
•taking the blood thinning drug warfarin
Advanced Ingredient Data
Raw Label Data
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Additional Information
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Source: dailymed · Ingested: 2026-02-15T12:01:02.463939 · Updated: 2026-03-14T23:01:15.754566