Night Time Severe Cold and Flu

Manufacturer
Walgreen Company | AptaPharma Inc.
Effective date
2023-12-29
Label type
HUMAN OTC DRUG LABEL
Version
3
Source
full-release
Hydrated at
2026-06-01 00:06:02

Label at a glance#

ProductNight Time Severe Cold and Flu
Active ingredientACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATE, PHENYLEPHRINE HYDROCHLORIDE
Label structure17 sections

Label contents#

Full prescribing information#

SPL UNCLASSIFIED SECTION

Drug Facts

OTC - ACTIVE INGREDIENT SECTION

Active ingredients
(in each 30 mL dose cup or 2 tablespoons)
Acetaminophen 650 mg 
Dextromethorphan HBr 20 mg
Doxylamine Succinate 12.5 mg
Phenylephrine HCl 10 mg

OTC - PURPOSE SECTION

Purpose
Acetaminophen ...................Pain reliever/Fever reducer
Dextromethorphan HBr........Cough suppressant
Doxylamine Succinate .........Antihistamine
Phenylephrine HCl ...............Nasal decongestant

INDICATIONS & USAGE SECTION

Uses Temporarily relieves cold/flu symptoms: ■ nasal
congestion ■ sinus congestion & pressure ■ sore throat
■ headache ■ minor aches and pain ■ runny nose and
sneezing ■ temporarily reduces fever ■ cough due to
minor throat and bronchial irritation ■ promotes nasal
and/or sinus drainage

WARNINGS SECTION

Warnings 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 ■ with other drugs containing
acetaminophen ■ 3 or more alcoholic drinks daily while
using this product. 

SPL UNCLASSIFIED SECTION

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.

SPL UNCLASSIFIED SECTION

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.

OTC - DO NOT USE SECTION

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 ■ to make a child sleep.

OTHER SAFETY INFORMATION

Ask a doctor before use if you have ■ a sodium
restricted diet. liver disease ■ heart disease ■
glaucoma ■ high blood pressure ■ thyroid disease
■ diabetes. 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.

OTC - ASK DOCTOR/PHARMACIST SECTION

Ask a doctor of pharmacist before use if you are ■ taking sedatives or

tranquilizers ■ taking the blood thinning drug warfarin.

OTC - WHEN USING SECTION

When using this product ■ do not use more than directed ■ avoid
alcoholic drinks ■ marked drowsiness may occur ■ excitability may occur,
especially in children, ■ be careful when driving a motor vehicle or operating
machinery ■ alcohol, sedatives, and tranquilizers may increase drowsiness.

OTC - STOP USE SECTION

Stop use and ask a doctor if ■ you get nervous, dizzy or sleepless ■ redness
or swelling is present ■ pain, nasal congestion, or cough gets worse or lasts more
than 7 days ■ fever gets worse or lasts more than 3 days ■ new symptoms occur
■ cough comes back or occurs with rash or headache that lasts. These could be
signs of a serious condition.

OTC - PREGNANCY OR BREAST FEEDING SECTION

If pregnant or breast-feeding, ask a health professional before use.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Keep out of reach of children. In case of overdose, get medical help or contact a Poison
Control Center right away. Quick medical attention is critical for adults as well as
for children even if you do not notice any signs or symptoms.

DOSAGE & ADMINISTRATION SECTION

Directions

■ take only as recommended.  See Warnings

■ use dose cup or tablespoon (TBSP)

■ do not exceed 4 doses per 24 hours

                         Age               Dose
 Adults & children 12 years & over 30 mL (2 TBSP) every 4 hours
 Children 4 to under 12 years Ask a doctor
 Children under 4 years Do not use

■ do not exceed 4 doses per 24 hours

OTHER SAFETY INFORMATION

Other information
■ each 30 mL contains: sodium 45 mg
■ store at room temperature

INACTIVE INGREDIENT SECTION

Inactive ingredients  anhydrous citric acid, dextrose, D&C Yellow # 10, FD&C Green
# 3, FD&C Yellow # 6, flavor, glycerin, propylene glycol, purified water,
saccharin sodium, sodium benzoate, sodium chloride, sorbitol, xanthan gum

OTC - QUESTIONS SECTION

Questions? Call weekdays from 9:30 AM to 4:30 PM EST at 1-877-798-5944.

Product Label

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Walgreens

Compare to Vicks® NyQuil™
Severe Nighttime Cold & 
Flu Relief active ingredients††

                         NDC 0363-0331-26

NIGHTTIME

Severe Cold & Flu

ACETAMINOPHEN / FEVER REDUCER
DEXTROMETHORPHAN HBr / COUGH SUPPRESSANT
DOXYLAMINE SUCCINATE / ANTIHISTAMINE
PHENYLPHRINE HCl / NASAL DECONGESTANT

AMAXIMUM STRENGTH

• Pain reliever, fever reducer,
   cough suppressant, antihistamine
   & nasal decongestant

ORIGINAL

FLAVOR

8 FL OZ (237 mL)

DO NOT USE IF IMPRINTED SHRINK BAND IS MISSING OR TORN

DISTRIBUTED BY WALGREEN CO., 200 WILMONT RD., DEERFIELD, IL 60015

100 % SATISFACTION GUARANTEED walgreens.com@2020WalgreenVo.

LR-151

ORG1020-F

0331-26.jpg0331-26.jpg

res

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
1431245acetaminophen 650 MG / dextromethorphan HBr 20 MG / doxylamine succinate 12.5 MG / phenylephrine HCl 10 MG in 30 mL Oral SolutionPSN3
1431245acetaminophen 21.7 MG/ML / dextromethorphan hydrobromide 0.667 MG/ML / doxylamine succinate 0.417 MG/ML / phenylephrine hydrochloride 0.333 MG/ML Oral SolutionSCD3
1431245acetaminophen 325 MG / dextromethorphan HBr 10 MG / doxylamine succinate 6.25 MG / phenylephrine HCl 5 MG per 15 ML Oral SolutionSY3
1431245acetaminophen 650 MG / dextromethorphan HBr 20 MG / doxylamine succinate 12.5 MG / phenylephrine HCl 10 MG per 30 ML Oral SolutionSY3
1431245APAP 21.7 MG/ML / Dextromethorphan Hydrobromide 0.667 MG/ML / doxylamine succinate 0.417 MG/ML / Phenylephrine Hydrochloride 0.333 MG/ML Oral SolutionSY3

DailyMed Pharmacologic Classes#

Class, Version, Type table
ClassVersionTypeEffective
DEXTROMETHORPHAN Pharmacologic Class Indexing2Indexing - Pharmacologic Class20180813
DOXYLAMINE Pharmacologic Class Indexing2Indexing - Pharmacologic Class20180813
PHENYLEPHRINE Pharmacologic Class Indexing2Indexing - Pharmacologic Class20180813

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
59361619-24d9-b610-eca6-5a7f25ed5e03Product name520240909
f4368033-af8c-41bf-a84b-ff77392b8522Product name120161229

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
0363-0331-26Night Time Severe Cold and Flu237 mL in 1 BOTTLELIQUID2373

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0363-0331NIGHT TIME SEVERE COLD AND FLU (ACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE, PHENYLEPHRINE HCL) LIQUID [WALGREEN COMPANY]3Current NDC, Legacy NDC, 1 package rows20231230_de2b2e34-62a5-451f-ab68-531d1c9d4d82.zip

Products#

Every source-derived product name is available through these pages.

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NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
0363-03310363-0331-26

Ingredients#

Every source-derived ingredient row is available through these pages.

DailyMed ingredient rows page 1 of 1 · 16 matching rows.

Source Document#

Source XML

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Night Time Severe Cold and FluACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE, PHENYLEPHRINE HCLWalgreen Companyde2b2e34-62a5-451f-ab68-531d1c9d4d822023-12-29WarningsExact identifier
ndc (package): 0363-0331-26
ndc (product): 0363-0331
ndc11 (package): 00363033126
spl id: 6e90a856-b1f6-4a6e-bf4c-b341d3e1cee7
spl set id: de2b2e34-62a5-451f-ab68-531d1c9d4d82

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.