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
Active Ingredient
Acetaminophen 650 mg
Dextromethorphan HBr 20 mg
Doxylamine succinate 12.5 mg
Phenylephrine HCl 10 mg
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
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 |
Other Information
-
•each 30 mL contains: sodium 77 mg
-
•Store at room temperature.
-
•Do not refrigerate.
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.
Description
Drug Facts Active ingredients (in each 30 mL)
Questions?
1-866-467-2748
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
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.
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
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.
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
Active Ingredient (55106-9)
Acetaminophen 650 mg
Dextromethorphan HBr 20 mg
Doxylamine succinate 12.5 mg
Phenylephrine HCl 10 mg
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
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 |
Other Information (Other information)
-
•each 30 mL contains: sodium 77 mg
-
•Store at room temperature.
-
•Do not refrigerate.
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.
Questions?
1-866-467-2748
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
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.
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
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.
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
All Sections (JSON)
Additional Information
Back to search View SPL set listing Open on DailyMed ↗
Source: dailymed · Ingested: 2026-02-15T12:01:02.463939 · Updated: 2026-03-14T23:01:15.754566