Daytime Cold and Flu

Manufacturer
Walgreen Company
Effective date
2020-03-06
Label type
HUMAN OTC DRUG LABEL
Version
4
Source
legacy-cache
Hydrated at
2026-08-01 23:39:41

Label at a glance#

ProductDaytime Cold and Flu Non Drowsy
Active ingredientACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, PHENYLEPHRINE HYDROCHLORIDE
Label structure10 sections

Indications and uses

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

Dosage and administration

take only as directed - see Overdose warning do not exceed 4 doses in 24 hours Adults and children 12 years and over 2 capsules with water every 4 hours children 4 to under 12 years ask a doctor children under 4 yrs do not use When using other Daytime or Nighttime products, carefully read each label to ensure correct dosing

Storage and handling

store at controlled room temperature 15°C to 30°C (59°F to 86°F) see end flap for expiration date and lot number

Label contents#

Full prescribing information#

SPL PRODUCT DATA ELEMENTS SECTION

SPL UNCLASSIFIED SECTION

Active ingredients (in each liquid cap)

OTC - ACTIVE INGREDIENT SECTION

Acetaminophen 325 mg

Dextromethorphan HBr 10 mg

Phenylephrine HCl 5 mg

Purpose

OTC - PURPOSE SECTION

Pain reliever/fever reducer

Cough suppressant

Nasal decongestant

Uses

INDICATIONS & USAGE SECTION

temporarily relieves common cold/flu symptoms:

  • nasal congestion
  • cough due to minor throat and bronchial irritation
  • sore throat
  • headache
  • minor aches and pains
  • fever

Warnings

WARNINGS SECTION

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 daily while using this product

Sore throat warning: If sore throat is severe, persists for more than 2 days, 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.

Ask a doctor before use if you have

OTC - ASK DOCTOR SECTION

  • liver disease
  • heart disease
  • thyroid disease
  • diabetes
  • high blood pressure
  • trouble urinating due to an enlarged prostate gland
  • cough that occurs with too much phlegm (mucus)
  • persistent or chronic cough as occurs with smoking, asthma or emphysema

Ask a doctor or pharmacist before use if you are

OTC - ASK DOCTOR/PHARMACIST SECTION

taking the blood thinning drug warfarin

When using this product,

OTC - WHEN USING SECTION

do not use more than directed.

Stop use and ask a doctor if

OTC - STOP USE SECTION

  • you get nervous, dizzy or sleepless.
  • symptoms get worse or last more than 5 days (children) or 7 days (adults)
  • 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.

If pregnant or breast-feeding,

OTC - PREGNANCY OR BREAST FEEDING SECTION

 ask a health professional before use.

Keep out of reach of children.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Overdose warning: Taking more than directed 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 and for children even if you do not notice any signs or symptoms.

Directions

DOSAGE & ADMINISTRATION SECTION

  • take only as directed - see Overdose warning
  • do not exceed 4 doses in 24 hours
    Adults and children 12 years and over2 capsules with water every 4 hours
    children 4 to under 12 yearsask a doctor
    children under 4 yrsdo 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 controlled room temperature 15°C to 30°C (59°F to 86°F)
  • see end flap for expiration date and lot number

Inactive ingredients

INACTIVE INGREDIENT SECTION

FD&C red #40, FD&C yellow #6*, gelatin, glycerin, polyethylene glycol, povidone, propylene glycol, purified water, sorbitol sorbitan solution, white ink 

Questions or comments?

OTC - QUESTIONS SECTION

1-800-706-5575

Principal Display Panel

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

MULTI SYMPTOM

NONDROWSY • DAYTIME

Cold & Flu

Acetaminophen/

Aches/ Fever/ Sore throat

Dextromethorphan HBr/ Cough

Phenylephrine/ Nasal Congestion

16 Liquid Caps

Compare to Vicks® DayQuil® LiquiCaps® active ingedients‡

daytime-16ct-ctndaytime-16ct-ctn

 

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0363-1140-01EA - Each0363-11403c125216-5e8f-4e9c-9cba-5100689ae19612020-04-20
0363-1140-02EA - Each0363-114061292bef-6f86-448f-8bf8-eb17c3a6163712020-04-20

Products#

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

DailyMed product names page 1 of 1 · 16 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
0363-11400363-1140-01, 0363-1140-02

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 12 matching rows.

Source Document#

Source XML · Source PDF

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
3622f92e-fd59-f01f-292b-806c62e20bc7bc90482e-bee0-7ee5-9fa0-cd137bb37e1d2020-03-06WarningsExact identifier
spl id: 3622f92e-fd59-f01f-292b-806c62e20bc7
spl set id: bc90482e-bee0-7ee5-9fa0-cd137bb37e1d

Reported adverse events (FAERS/openFDA)#

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