Severe Cold And Flu Solution
FDA Label NDC 0363-0763

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

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Walgreen Company for the product Severe Cold And Flu (NDC 0363-0763). 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 nighttime severe cold & fluactive ingredients (in each 30 ml), purpose, uses, warnings, do not use, ask a doctor before use if you have, ask a doctor or pharmacist before use if you are, when using this product, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Label Section Quick Index

Nighttime Severe Cold & Fluactive Ingredients (In Each 30 Ml)

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 4,000 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.

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

      • adult takes more than 4,000 mg of acetaminophen in 24 hours
      • child takes more than 5 doses in 24 hours
      • taken with other drugs containing acetaminophen
      • adult has 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.
  • 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.
    • if you have ever had an allergic reaction to this product or any of its ingredients

Ask A Doctor Before Use If You Have

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

Ask A Doctor Or Pharmacist Before Use If You Are

  • taking sedatives or tranquilizers
  • taking the blood thinning drug warfarin

    • taking the blood thinning drug warfarin

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 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,

ask a health professional before use.

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 (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.

Overdose warning: In case of overdose, get medical help or contact a Poison Control Center right away (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.

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 - 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 6 to under 12 yrs

      15 mL every 4 hrs

      children 4 to under 6 yrs

      ask a doctor

      children under 4 yrs

      do not use

Other Information

  • each 30 mL contains: sodium 12 mg
  • store at 20-25°C (68-77°F)
    • each 15 mL contains: sodium 6 mg
    • store at 20-25°C (68-77°F). Do not refrigerate.

Inactive Ingredients

butylated hydroxyanisole, edetate disodium, FD&C blue #1, FD&C red #40, flavor, glycerin, monobasic sodium phosphate, polyethylene glycol, propylene glycol, purified water, saccharin sodium, sucrose, xanthan gum

butylated hydroxyanisole, edetate disodium, FD&C yellow #6, flavor, glycerin, menthol, monobasic sodium phosphate, polyethylene glycol, propylene glycol, purified water, saccharin sodium, sucrose, xanthan gum

Questions Or Comments?

1-800-719-9260

1-800-719-9260

Daytime Severe Cold & Fluactive Ingredients (In Each 15 Ml)

Acetaminophen 325 mg

Dextromethorphan HBr 10 mg

Guaifenesin 200 mg

Phenylephrine HCl 5 mg

Principal Display Panel

COMBO PACK

DAYTIME – NON-DROWSY

MAXIMUM STRENGTH

SEVERE

Cold & Flu

Acetaminophen / Aches / Fever / Sore Throat

Dextromethorphan HBr / Cough

Guaifenesin / Chest Congestion

Phenylephrine HCl / Nasal Congestion

Pain reliever, fever reducer, cough suppressant, expectorant & nasal decongestant

Antihistamine free

Alcohol free

SEE NEW WARNINGS

12 FL OZ (355 mL)

DAYTIME

Compare to active ingredients in Vicks® DayQuil® Severe Cold & Flu & Vicks® NyQuil® Severe Cold & Flu

Total 24 FL OZ (1.5 pt) (710 mL) Two 12 FL OZ (355 mL) Units

COMBO PACK

NIGHTTIME

MAXIMUM STRENGTH

SEVERE

Cold & Flu

Acetaminophen / Aches / Fever / Sore Throat

Dextromethorphan HBr / Cough

Doxylamine Succinate / Sneezing / Runny Nose

Phenylephrine HCl / Nasal & Sinus Congestion / Sinus Pressure

Pain reliever, fever reducer, cough suppressant, antihistamine & nasal decongestant

SEE NEW WARNINGS

12 FL 0Z (355 mL)

NIGHTTIME

MIXED BERRY FLAVOR

Compare to active ingredients in Vicks® DayQuil® Severe Cold & Flu & Vicks® NyQuil® Severe Cold & Flu

Total 24 FL OZ (1.5 pt) (710 mL) Two 12 FL OZ (355 mL) Units

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