Vicks Dayquil And Vicks Nyquil Kit
FDA Label NDC 37000-814

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

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by The Procter & Gamble Manufacturing Company for the product Vicks Dayquil And Vicks Nyquil (NDC 37000-814). 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 other, otc - purpose, uses, liver warning, sore throat warning, do not use, ask a doctor before use if you have, otc - ask doctor/pharmacist, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Other

DayQuil Severe Cold & Flu

Drug Facts

NyQuil Severe Cold & Flu

Drug Facts

Dist. by Proctor & Gamble, Cincinnati OH 45202

Otc - Purpose

Active ingredients (in each 15 mL tablespoon)Purpose
Acetaminophen 325 mgPain reliever/fever reducer
Dextromethorphan HBr 10 mgCough suppressant
Guaifenesin 200 mgExpectorant
Phenylephrine HCl 5 mgNasal decongestant
Active ingredients (in each 30 mL dose cup)Purpose
Acetaminophen 650 mgPain reliever/fever reducer
Dextromethorphan HBr 20 mgCough suppressant
Doxylamine succinate 12.5 mgAntihistamine
Phenylephrine HCl 10 mgNasal decongestant

Uses

  • temporarily relieves common cold/flu symptoms:
    • nasal congestion
    • sinus congestion & pressure
    • cough due to minor throat & bronchial irritation
    • minor aches & 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.
    • temporarily relieves common cold/flu symptoms:

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

Liver Warning

This product contains acetaminophen. Severe liver damage may occur if

  • adult takes more than 4 doses (30 mL each) in 24 hrs
  • child takes more than 4 doses (15 mL each) in 24 hrs
  • taken with other drugs containing acetaminophen
  • adult has 3 or more alcoholic drinks every day while using this product
  • 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

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.

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.
    • to make a child sleep

Ask A Doctor Before Use If You Have

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

Otc - Ask Doctor/Pharmacist

Ask a doctor or pharmacist before use if you are taking the blood thinning drug warfarin.

Otc - When Using

When using this product, 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 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.

    • 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.

Otc - Pregnancy Or Breast Feeding

If pregnant or breast-feeding, ask a health professional before use.

If pregnant or breast-feeding, ask a health professional before use.

Otc - Keep Out Of Reach Of Children

Keep out of reach of children.

Keep out of reach of children.

Overdose Warning

Taking more than directed can 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 as well as for children even if you do not notice any signs or symptoms.

Taking more than directed can 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 as well as for children even if you do not notice any signs or symptoms.

Directions

  • take only as directed - see Overdose warning
  • use dose cup or tablespoon (TBSP)
  • do not exceed 4 doses per 24 hrs
  • adults & children 12 yrs & over30 mL (2 TBSP) every 4 hrs
    children 6 to under 12 yrs15 mL (1 TBSP) every 4 hrs
    children 4 to under 6 yrsask a doctor
    children under 4 yrsdo not use
    • when using other DayQuil or NyQuil ® products, carefully read each label to ensure correct dosing
      • take only as directed - see Overdose warning
      • use dose cup or tablespoon (TBSP)
      • do not exceed 4 doses per 24 hrs
      • adults & children 12 yrs & over30 mL (2 TBSP) every 4 hrs
        children 4 to under 12 yrsask a doctor
        children under 4 yrsdo not use
        • when using other DayQuil ® or NyQuil products, carefully read each label to ensure correct dosing

Other Information

  • each 15 mL tablespoon contains: sodium 47 mg
  • store at room temperature
    • each 30 mL dose cup contains: sodium 92 mg
    • store at room temperature

Inactive Ingredients

citric acid, FD&C Yellow No. 6, flavor, glycerin, propylene glycol, purified water, saccharin sodium, sodium benzoate, sodium chloride, sodium citrate, sorbitol, sucralose, xanthan gum

citric acid, FD&C Blue No. 1, FD&C Red No. 40, flavor, glycerin, propylene glycol, purified water, saccharin sodium, sodium benzoate, sodium chloride, sodium citrate, sorbitol, sucralose, xanthan gum

Questions?

1-800-251-3374

1-800-362-1683

Ask A Doctor Or Pharmacist Before Use If You Are

  • taking sedatives or tranquilizers
  • 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

Principal Display Panel - Kit Carton

NEW
Fights More
Symptoms

than DayQuil/NyQuil
Cold & Flu

VICKS ®

DayQuil®
SEVERE

COLD & FLU

Acetaminophen, Phenylephrine HCl, Dextromethorphan HBr,
Guaifenesin

MAX
STRENGTH

Non-Drowsy
Alcohol Free

  • Headache, Fever, Sore Throat
    Minor Aches & Pains
  • Nasal/Sinus Congestion & Sinus Pressure
  • Cough
  • Chest Congestion
  • DayQuil Severe ONE 12 FL OZ (354 ml) BOTTLE:
    TOTAL 24 FL

    NyQuil®
    SEVERE

    COLD & FLU

    Nighttime Relief

    Acetaminophen, Phenylephrine HCl, Doxylamine Succinate,
    Dextromethorphan HBr

    MAX
    STRENGTH

    Berry Flavor

    • Headache, Fever, Sore Throat
      Minor Aches & Pains
    • Nasal/Sinus Congestion & Sinus Pressure
    • Sneezing, Runny Nose
    • Cough
    • NyQuil Severe ONE 12 FL OZ (354 ml) BOTTLE
      OZ (708 ml)

      Principal Display Panel (Kit Carton)

      Principal Display Panel (Kit Carton)

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