Walgreen Day Time Nighttime Cold And Flu Relief Kit
FDA Label NDC 0363-6105

Full FDA labeling including Indications, Dosage, Usage, and Precautions

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Walgreens Co. for the product Walgreen Day Time Nighttime Cold And Flu Relief (NDC 0363-6105). This document serves as the official prescribing information, containing essential scientific data and clinical materials required for healthcare providers and patients.

This specific version of the label includes detailed information regarding active ingredients (in each 30 ml) – nighttime, purpose, uses, warnings, do not use, when using this product, stop use and ask a doctor if, directions, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Label Section Quick Index

Active Ingredients (In Each 30 Ml) – Nighttime

Acetaminophen 650 mg

Dextromethorphan HBr 20 mg

Doxylamine succinate 12.5 mg

Phenylephrine HCl 10 mg

Purpose

Pain reliever/fever reducer

Cough suppressant

Antihistamine

Nasal decongestant

Pain reliever/fever reducer

Cough suppressant

Expectorant

Nasal decongestant

Uses

temporarily relieves common cold/flu symptoms:

  • nasal congestion
  • sinus congestion and pressure
  • minor aches and pains
  • headache
  • fever
  • sore throat
  • runny nose and sneezing
  • cough due to minor throat and bronchial irritation
  • cough to help you sleep
  • reduces swelling of nasal passages
  • promotes nasal and/or sinus drainage
  • temporarily restores freer breathing through the nose

    • temporarily relieves common cold/flu symptoms:

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

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 for this product
  • 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.

      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 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

  • 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.
    • 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.

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 when driving a motor vehicle or operating machinery
  • alcohol, sedatives, and tranquilizers may increase drowsiness

    • do not use more than directed

Stop Use And Ask A Doctor If

  • you get nervous, dizzy or sleepless
  • 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.
    • you get nervous, dizzy or sleepless
    • 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.

Directions

  • take only as directed – see Overdose warning
  • only use the dose cup provided
  • do not exceed 4 doses per 24 hrs

    • adults & children 12 yrs & over

    30 mL every 4 hrs

    children 4 to under 12 yrs

    ask a doctor

    children under 4 yrs

    do not use

    • take only as directed
    • only use the dose cup provided
    • do not exceed 4 doses per 24 hrs

      • adults & children 12 yrs & over

      30 mL every 4 hrs

      children 4 to under 12 yrs

      ask a doctor

      children under 4 yrs

      do not use

Other Information

  • each 30 mL contains: sodium 81 mg
  • store at room temperature
  • Do not refrigerate
    • each 30 mL contains: sodium 81 mg
    • store at room temperature.
    • Do not refrigerate.

Inactive Ingredients

citric acid, D&C yellow #10, edetate disodium, FD&C blue #1, flavor, glycerin, propyl gallate, propylene glycol, purified water, sodium benzoate, sodium chloride, sodium citrate, sorbitol, sucralose

citric acid, D&C yellow #10, edetate disodium,

FD&C blue #1, flavor, glycerin, propyl gallate, propylene glycol, purified water, sodium benzoate, sodium chloride, sodium citrate, sorbitol, sucralose

Questions Or Comments?

1-866-467-2748

Active Ingredients (In Each 30 Ml) - Day Time

Acetaminophen 650 mg

Dextromethorphan HBr 20 mg

Guaifenesin 400 mg

Phenylephrine HCl 10 mg

If Pregnant Or Breast-Feeding,

ask a health professional before use.

Keep Out Of Reach Of Children.

Overdose warning: In case of overdose, get medical help or contact a Poison Control Center right away at (1-800-222-1222). Quick medical attention is critical for adults as well as for children even if you do not notice any signs or symptoms.

Package/Label Principal Display Panel

VALUE PACK

*Compare to the active ingredients in Vicks® Dayquil® Severe+ VapoCOOL™

DayTime

Cold & Flu

Relief

Acetaminophen - Pain reliever / Fever reducer

Dextromethorphan HBr - Cough supressant

Guaifenesin - Expectorant

Phenylephrine HCl - Nasal decongestant

For Relief of

  • Minor Aches & Pains, Fever
  • Nasal Congestion & Sinus Pressure
  • Cough
  • Chest Congestion

    • TWO BOTTLES, 12 FL OZ (354 mL)

    **Compare to the active ingredients in Vicks® Nyquil® Severe+ VapoCOOL™

    NightTime

    Cold & Flu

    Relief

    Acetaminophen - Pain reliever / Fever reducer

    Dextromethorphan HBr - Cough supressant

    Doxylamine succinate - Antihistamine

    Phenylephrine HCl - Nasal decongestant

    For Relief of

    • Minor Aches & Pains, Fever
    • Nasal Congestion & Sinus Pressure
    • Sneezing, Runny Nose
    • Cough

      • Each; TOTAL 24 FL OZ (708 mL)

* Please review the disclaimer below.