FDA.reportPublic FDA data

Walgreens NightTime Cold and Flu

Manufacturer
WALGREEN COMPANY | SPIRIT PHARMACEUTICALS LLC
Effective date
2020-12-09
Label type
HUMAN OTC DRUG LABEL
Version
3
Source
full-release
Hydrated at
2026-05-31 23:34:51

Label at a glance#

ProductWalgreens NightTime Cold and Flu
Active ingredientACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATE
Label structure10 sections

Indications and uses

temporarily relieves common cold/flu symptoms: cough due to minor throat and bronchial irritation sore throat headache minor aches/pains fever runny nose and sneezing

Dosage and administration

Take only as recommended—see Overdose warning . do not exceed 4 doses per 24 hours adults and children 12 years of age and over swallow 2 softgels with water every 6 hours children 4 to under 12 years of age ask a doctor children under 4 years of age do not use When using other Daytime or Nighttime products, carefully read each label to ensure correct dosing

Storage and handling

store at room temperature 15°-30°C (59°-86°F) and avoid excessive heat

Label contents#

Full prescribing information#

SPL UNCLASSIFIED SECTION

Drug Facts

OTC - ACTIVE INGREDIENT SECTION

OTC - PURPOSE SECTION

Active ingredients (in each softgel)Purpose
Acetaminophen 325 mgPain reliever/fever reducer
Dextromethorphan Hydrobromide 15 mgCough suppressant
Doxylamine Succinate 6.25 mgAntihistamine

Uses

INDICATIONS & USAGE SECTION

temporarily relieves common cold/flu symptoms:

  • cough due to minor throat and bronchial irritation
  • sore throat
  • headache
  • minor aches/pains
  • fever
  • runny nose and sneezing

Warnings

WARNINGS SECTION

Liver warning

SPL UNCLASSIFIED SECTION

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

Sore throat warning

SPL UNCLASSIFIED SECTION

If sore throat is severe, lasts for more than 2 days, or occurs with or is followed by fever, headache, rash, nausea, or vomiting, see a doctor promptly.

Do not use

OTC - DO NOT USE SECTION

  • 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

OTC - ASK DOCTOR SECTION

Ask a doctor before use if you have

  • liver disease
  • 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

OTC - ASK DOCTOR/PHARMACIST SECTION

Ask a doctor or 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
  • excitability may occur especially in children
  • marked drowsiness may occur
  • avoid alcoholic drinks
  • be careful with 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

  • pain 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

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.

Overdose warning

SPL UNCLASSIFIED SECTION

Taking more than the recommended dose can cause serious health problems. 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.

Directions

DOSAGE & ADMINISTRATION SECTION

  • Take only as recommended—see Overdose warning.
  • do not exceed 4 doses per 24 hours
    adults and children 12 years of age and overswallow 2 softgels with water every 6 hours
    children 4 to under 12 years of ageask a doctor
    children under 4 years of agedo not use

When using other Daytime or Nighttime products, carefully read each label to ensure correct dosing

Other information

STORAGE AND HANDLING SECTION

  • store at room temperature 15°-30°C (59°-86°F) and avoid excessive heat

Inactive ingredients

INACTIVE INGREDIENT SECTION

D&C Yellow No. 10, FD&C Blue No. 1, gelatin, glycerin, polyethylene glycol 400, povidone, propylene glycol, purified water, sorbitol sorbitan, titanium dioxide

Questions or comments?

OTC - QUESTIONS SECTION

1-888-333-9792

SPL UNCLASSIFIED SECTION

DISTRIBUTED BY: WALGREEN CO.
200 WILMOT RD., DEERFIELD, IL 60015

PRINCIPAL DISPLAY PANEL 

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Walgreens

Cold & Flu

COMPARE TO ACTIVE INGREDIENTS IN
VICKS ® NYQUIL ® LiquiCaps® active ingredients††

MULTI-SYMPTOM

NIGHTTIME COLD & FLU

  • Acetaminophen 325mg/ ACHES/ FEVER/ SORE THROAT
  • Dextromethorphan HBr 15mg/ COUGH
  • Doxylamine Succinate 6.25mg/ SNEEZING/ RUNNY NOSE

Relieves aches, fever, sore throat,
cough, sneezing & runny nose

Actual Size

16 LIQUID CAPS

†††† This product is not manufactured or distributed by
Procter & Gamble, owner of the registered
trademarks Vicks® NyQuil® LiquiCaps®

image descriptionimage description

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
1094549acetaminophen 325 MG / dextromethorphan HBr 15 MG / doxylamine succinate 6.25 MG Oral CapsulePSN3
1094549acetaminophen 325 MG / dextromethorphan hydrobromide 15 MG / doxylamine succinate 6.25 MG Oral CapsuleSCD3
1094549APAP 325 MG / dextromethorphan hydrobromide 15 MG / doxylamine succinate 6.25 MG Oral CapsuleSY3

DailyMed Pharmacologic Classes#

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

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
0363-1168-162022-01-28C16284748780-1d6a99b39-65db-a426-e053-dadaa90af4c2Walgreens NightTime Cold and Flu

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
0363-1168-16Walgreens NightTime Cold and Flu2 in 1 CARTONCAPSULE, LIQUID FILLED23
0363-1168-16Walgreens NightTime Cold and Flu8 in 1 BLISTER PACKCAPSULE, LIQUID FILLED83

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0363-1168WALGREENS NIGHTTIME COLD AND FLU (ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, AND DOXYLAMINE SUCCINATE) CAPSULE, LIQUID FILLED [WALGREEN COMPANY]3Legacy NDC, 2 package rows20201210_a4001791-4c35-4c2c-862b-6d031bffb51b.zip

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0363-1168-16EA - Each0363-1168d26b52cb-bcc1-45d0-928c-4db2baaffa8212022-06-06

Products#

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

DailyMed product names page 1 of 1 · 17 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
0363-11680363-1168-16

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 13 matching rows.

Name, UNII, Kind table
NameUNIIKind
D&C YELLOW NO. 1035SW5USQ3GIACT
FD&C BLUE NO. 1H3R47K3TBDIACT
GELATIN2G86QN327LIACT
GLYCERINPDC6A3C0OXIACT
POLYETHYLENE GLYCOL 400B697894SGQIACT
POVIDONE, UNSPECIFIEDFZ989GH94EIACT
PROPYLENE GLYCOL6DC9Q167V3IACT
WATER059QF0KO0RIACT
SORBITOL506T60A25RIACT
TITANIUM DIOXIDE15FIX9V2JPIACT
ACETAMINOPHEN362O9ITL9DACTIB
DEXTROMETHORPHAN HYDROBROMIDE9D2RTI9KYHACTIB
DOXYLAMINE SUCCINATEV9BI9B5YI2ACTIB

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
b60b24a6-fdb6-244f-e053-2a95a90a3c4da4001791-4c35-4c2c-862b-6d031bffb51b2020-12-09WarningsExact identifier
spl id: b60b24a6-fdb6-244f-e053-2a95a90a3c4d
spl set id: a4001791-4c35-4c2c-862b-6d031bffb51b

Reported adverse events (FAERS/openFDA)#

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