Cold and Flu

Manufacturer
Walgreen Company | LNK International, Inc.
Effective date
2021-12-09
Label type
HUMAN OTC DRUG LABEL
Version
2
Source
legacy-cache
Hydrated at
2026-08-01 22:23:59

Label at a glance#

ProductCold and Flu Daytime, Nighttime
Active ingredientACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, PHENYLEPHRINE HYDROCHLORIDE, DOXYLAMINE SUCCINATE
Label structure13 sections

Indications and uses

temporarily relieves common cold and flu symptoms: fever headache sore throat minor aches and pains cough due to minor throat and bronchial irritation nasal congestion (Daytime only) runny nose and sneezing (Nighttime only)

Dosage and administration

do not take more than directed do not take more than 8 capsules per 24 hours adults and children 12 years and over: take 2 capsules with water every 4 hours children under 12 years: ask a doctor

Storage and handling

TAMPER EVIDENT: DO NOT USE IF OUTER PACKAGE IS OPENED OR BLISTER IS TORN OR BROKEN store at 25ºC (77ºF); excursions permitted between 15º-30ºC (59º-86ºF) protect from light, heat and moisture see end flap for expiration date and lot number

Label contents#

Full prescribing information#

Active ingredients (in each liquid-filled capsule) (Daytime Cold & Flu)

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

Active ingredients (in each liquid-filled capsule) (Nighttime Cold & Flu)

OTC - ACTIVE INGREDIENT SECTION

Acetaminophen 325 mg
Dextromethorphan HBr 15 mg
Doxylamine succinate 6.25 mg

Purpose

OTC - PURPOSE SECTION

Pain reliever/fever reducer
Cough suppressant
Antihistamine

Uses

INDICATIONS & USAGE SECTION

  • temporarily relieves common cold and flu symptoms:
    • fever
    • headache
    • sore throat
    • minor aches and pains
    • cough due to minor throat and bronchial irritation
    • nasal congestion (Daytime only)
    • runny nose and sneezing (Nighttime only)

Warnings

WARNINGS SECTION

Liver warning: This product contains acetaminophen. Severe liver damage may occur if you take

  • more than 4,000 mg of acetaminophen in 24 hours
  • 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.

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.
  • if you have ever had an allergic reaction to this product or any of its ingredients

Ask a doctor before use if you have

OTC - ASK DOCTOR SECTION

  • cough that occurs with too much phlegm (mucus)
  • liver disease
  • difficulty in urination due to enlargement of the prostate gland
  • heart disease (Daytime only)
  • diabetes (Daytime only)
  • thyroid disease (Daytime only)
  • high blood pressure (Daytime only)
  • persistent or chronic cough such as occurs with smoking, asthma, or emphysema (Daytime only)
  • a breathing problem or chronic cough that lasts or as occurs with smoking, asthma, chronic bronchitis, or emphysema (Nighttime only)
  • glaucoma (Nighttime only)

Ask a doctor or pharmacist before use if you are

OTC - ASK DOCTOR/PHARMACIST SECTION

  • taking the blood thinning drug warfarin
  • taking sedatives or tranquilizers (Nighttime only)

When using this product

OTC - WHEN USING SECTION

  • do not exceed recommended dosage
  • excitability may occur, especially in children (Nighttime only)
  • avoid alcoholic beverages (Nighttime only)
  • marked drowsiness may occur (Nighttime only)
  • alcohol, sedatives, and tranquilizers may increase drowsiness (Nighttime only)
  • use caution when driving a motor vehicle or operating machinery (Nighttime only)

Stop use and ask a doctor if

OTC - STOP USE SECTION

  • nervousness, dizziness, or sleeplessness occur (Daytime only)
  • pain, nasal congestion, or cough gets worse or lasts more than 7 days (Daytime only)
  • pain or cough gets worse or lasts more than 7 days (Nighttime only)
  • 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

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

Read each section carefully. Do not take DAYTIME and NIGHTTIME products at the same time.

Directions (Daytime only)

DOSAGE & ADMINISTRATION SECTION

  • do not take more than directed
  • do not take more than 8 capsules per 24 hours
  • adults and children 12 years and over: take 2 capsules with water every 4 hours
  • children under 12 years: ask a doctor

Directions (Nighttime only)

DOSAGE & ADMINISTRATION SECTION

  • do not take more than directed
  • do not take more than 8 capsules per 24 hours
  • adults and children 12 years and over: take 2 capsules with water every 6 hours
  • children under 12 years: ask a doctor

Do not take more than 8 capsules of Daytime and Nighttime products in any 24-hour period.

Other information

STORAGE AND HANDLING SECTION

  • TAMPER EVIDENT: DO NOT USE IF OUTER PACKAGE IS OPENED OR BLISTER IS TORN OR BROKEN
  • store at 25ºC (77ºF); excursions permitted between 15º-30ºC (59º-86ºF)
  • protect from light, heat and moisture
  • see end flap for expiration date and lot number

Inactive ingredients (Daytime only)

INACTIVE INGREDIENT SECTION

FD&C red #40, FD&C yellow #6, gelatin, glycerin, isopropyl alcohol, medium chain triglycerides, polyethylene glycol, povidone, propylene glycol, purified water, sorbitol sorbitan solution, white ink

Inactive ingredients (Nighttime only)

INACTIVE INGREDIENT SECTION

D&C yellow #10, FD&C blue #1, gelatin, glycerin, isopropyl alcohol, medium chain triglycerides, polyethylene glycol, povidone, propylene glycol, purified water, sorbitol sorbitan solution, white ink

Questions or comments?

OTC - QUESTIONS SECTION

1-800-426-9391

Principal Display Panel

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

DAY & NIGHT PACK

NDC 0363-7331-08

Walgreens

Compare to Vicks® DayQuil® & NyQuil® Cold & Flu LiquiCaps® active ingredients††

DAYTIME • NON-DROWSY
Cold & Flu

ACETAMINOPHEN /
PAIN RELIEVER / FEVER REDUCER
DEXTROMETHORPHAN HBr /
COUGH SUPPRESSANT
PHENYLEPHRINE HCl /
NASAL DECONGESTANT

MULTI-SYMPTOM

ACTUAL
SIZE

16
LIQUID
CAPS

NIGHTTIME
Cold & Flu

ACETAMINOPHEN /
PAIN RELIEVER / FEVER REDUCER
DEXTROMETHORPHAN HBr /
COUGH SUPPRESSANT 
DOXYLAMINE SUCCINATE /
ANTIHISTAMINE

MULTI-SYMPTOM

ACTUAL
SIZE

8 
LIQUID 
CAPS

24 TOTAL LIQUID CAPS

TAMPER EVIDENT: DO NOT USE IF PACKAGE IS OPENED OR IF BLISTER UNIT IS TORN, BROKEN OR SHOWS ANY SIGNS OF TAMPERING

Walgreens Pharmacist Recommended
Walgreens Pharmacist Survey

††This product is not manufactured or distributed by The Procter & Gamble Company, owner of the registered trademark Vicks® DayQuil® & NyQuil® Cold & Flu LiquiCaps®.

50844                  ORG012073073108

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

Walgreens
100% SATISFACTION GUARANTEED
walgreens.com ©2020 Walgreen Co.

PRODUCT OF DUBAI
PACKAGED AND QUALITY
ASSURED IN THE U.S.A.

Walgreens 44-730731
Walgreens 44-730731

Products#

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NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
0363-73310363-7331-08

Ingredients#

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DailyMed ingredient rows page 1 of 1 · 30 matching rows.

Source Document#

Source XML

openFDA label cross-check#

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Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
a37d2733-af9f-442a-8518-a3da87a4157ce0c1ac16-254d-4666-b62e-88a424b267512022-12-20WarningsExact identifier
spl set id: e0c1ac16-254d-4666-b62e-88a424b26751

Reported adverse events (FAERS/openFDA)#

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