MedPath

Cold and Flu

Walgreens 44-640677-08

Approved
Approval ID

4d199dc7-253f-48fd-a77d-f8b10f724dd1

Product Type

HUMAN OTC DRUG LABEL

Effective Date

Aug 18, 2025

Manufacturers
FDA

Walgreen Company

DUNS: 008965063

Products 1

Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.

Acetaminophen, Dextromethorphan HBr, Doxylamine succinate, Guaifenesin, Phenylephrine HCl

Product Details

FDA regulatory identification and product classification information

FDA Identifiers
NDC Product Code0363-6406
Application NumberM012
Product Classification
M
Marketing Category
C200263
G
Generic Name
Acetaminophen, Dextromethorphan HBr, Doxylamine succinate, Guaifenesin, Phenylephrine HCl
Product Specifications
Effective DateAugust 18, 2025
FDA Product Classification

Drug Labeling Information

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

LOINC: 51945-4Updated: 8/18/2025

Principal Display Panel

DAY & NIGHT PACK

Walgreens


****•WALGREENS
PHARMACIST RECOMMENDED†

Compare to the active ingredients in Vicks® DayQuil®
VapoCOOL® SEVERE COLD & FLU + CONGESTION and Vicks®
NyQuil® VapoCOOL® SEVERE COLD & FLU + CONGESTION††

DAYTIME

Severe
** Cold & Flu**

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

Maximum Strength

16 CAPLETS

ACTUAL SIZE

NIGHTTIME

Severe
****Cold & Flu

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

Maximum Strength

8 CAPLETS

ACTUAL SIZE

24 TOTAL CAPLETS

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

Do Not Take Daytime and
** Nighttime Products at the**
** Same Time.**

PARENTS:
Learn about teen medicine abuse
www.StopMedicineAbuse.org

†Our pharmacists recommend the Walgreens brand.
We invite you to compare to national brands.
††This product is not manufactured or distributed by
The Procter & Gamble Company, owner of the registered trademark
Vicks® DayQuil® VapoCOOL® SEVERE COLD
& FLU + CONGESTION and Vicks® NyQuil® VapoCOOL®
SEVERE COLD & FLU + CONGESTION.

50844 REV0722B64067708

NDC 0363-6406-08

DISTRIBUTED BY:WALGREEN CO.
** DEERFIELD, IL 60015**
Walgreens
** 100 % SATISFACTION**
** GUARANTEED**
** walgreens.com**
****©2024 Walgreen Co.

Walgreens 44-640677

Walgreens 44-640677

INDICATIONS & USAGE SECTION

LOINC: 34067-9Updated: 8/18/2025

Uses

  • temporarily relieves common cold and flu symptoms:
    • minor aches and pains
    • nasal congestion
    • headache
    • fever
    • sore throat
    • sinus congestion and pressure
    • cough due to minor throat and bronchial irritation
    • cough to help you sleep**(Nighttime only)**
    • runny nose and sneezing**(Nighttime only)**
  • reduces swelling of nasal passages
  • temporarily restores freer breathing through the nose
  • promotes nasal and/or sinus drainage
  • helps loosen phlegm (mucus) and thin bronchial secretions to rid the bronchial passageways of bothersome mucus and make coughs more productive**(Daytime only)**

OTC - ACTIVE INGREDIENT SECTION

LOINC: 55106-9Updated: 8/18/2025

Active ingredients (in each caplet) (Nighttime severe cold & flu)

Acetaminophen 325 mg
Dextromethorphan HBr 10 mg
Doxylamine succinate 6.25 mg
Phenylephrine HCl 5 mg

OTC - PURPOSE SECTION

LOINC: 55105-1Updated: 8/18/2025

Purpose

Pain reliever/fever reducer
Cough suppressant
Antihistamine
Nasal decongestant

INACTIVE INGREDIENT SECTION

LOINC: 51727-6Updated: 8/18/2025

Inactive ingredients (Nighttime only)


black iron oxide, corn starch, crospovidone, D&C yellow #10 aluminum lake, FD&C blue #1 aluminum lake, FD&C yellow #6 aluminum lake, magnesium stearate, microcrystalline cellulose, polyethylene glycol, polysorbate 80, polyvinyl alcohol, povidone, silicon dioxide, sodium starch glycolate, stearic acid, talc, titanium dioxide

WARNINGS SECTION

LOINC: 34071-1Updated: 8/18/2025

Warnings

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

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


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

Ask a doctor or pharmacist before use if you are


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

When using this product

*do not exceed recommended dosage

  • excitability may occur, especially in children**(Nighttime only)**
  • marked drowsiness may occur**(Nighttime only)**
  • avoid alcoholic beverages**(Nighttime only)**
  • be careful when driving a motor vehicle or operating machinery**(Nighttime only)**
  • alcohol, sedatives, and tranquilizers may increase drowsiness**(Nighttime only)**

Stop use and ask a doctor if

  • nervousness, dizziness, or sleeplessness occur
  • 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.

If pregnant or breast-feeding,

ask a health professional before use.

Keep out of reach of children

In case of 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.

Do not take DAYTIME and NIGHTTIME products at the same time.

OTC - QUESTIONS SECTION

LOINC: 53413-1Updated: 8/18/2025

Questions or comments?


1-800-426-9391

DOSAGE & ADMINISTRATION SECTION

LOINC: 34068-7Updated: 8/18/2025

Directions

*do not take more than directed

  • do not take more than 8 caplets of Daytime and Nighttime products in any 24-hour period
  • adults and children 12 years and over: take 2 caplets with water every 4 hours
  • children under 12 years: ask a doctor

STORAGE AND HANDLING SECTION

LOINC: 44425-7Updated: 8/18/2025

Other information

*each caplet contains: sodium 3 mg *TAMPER EVIDENT: DO NOT USE IF OUTER PACKAGE IS OPENED OR BLISTER IS TORN OR BROKEN

  • store at 25°C (77°F); excursions permitted between 15°-30°C (59°-86°F)
  • see end flap for expiration date and lot number

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Cold and Flu - FDA Drug Approval Details