Day Cold And Flu Plus And Nighttime Cold And Flu Plus
FDA Label NDC 69842-069

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

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Cvs Pharmacy, Inc. for the product Day Cold And Flu Plus And Nighttime Cold And Flu Plus (NDC 69842-069). 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 cold & flu formula day non-drowsyactive ingredients (in each softgel), cold & flu formula nightactive ingredients (in each softgel), purposes, uses, day cold & flu formulawarnings, do not use, ask a doctor before use if you have, stop use and ask a doctor if, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Cold & Flu Formula Day Non-Drowsyactive Ingredients (In Each Softgel)

Acetaminophen 325 mg 
Dextromethorphan hydrobromide 10 mg
Phenylephrine hydrochloride 5 mg

Cold & Flu Formula Nightactive Ingredients (In Each Softgel)

Acetaminophen 325 mg
Dextromethorphan hydrobromide 10 mg
Doxylamine succinate 6.25 mg
Phenylephrine hydrochloride 5 mg

Purposes

DAY COLD & FLU FORMULA

Pain reliever/fever reducer

Cough suppressant

Nasal decongestant

NIGHT COLD & FLU FORMULA

Pain reliever/fever reducer

Cough suppressant

Antihistamine

Nasal decongestant

Uses

DAY COLD & FLU FORMULA

  • temporarily relieves these symptoms due to a cold or flu:
    • minor aches and pains
    • headache
    • cough
    • sore throat
    • nasal and sinus congestion
    • temporarily reduces fever
    • NIGHT COLD & FLU FORMULA

      • temporarily relieves these symptoms due to a cold or flu:
        • minor aches and pains
        • headache
        • nasal and sinus congestion
        • cough
        • sore throat
        • runny nose
        • sneezing
        • temporarily reduces fever

Day Cold & Flu Formulawarnings

Liver warning

These products contain acetaminophen. Severe liver damage may occur if you take

  • more than 10 softgels 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.

    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.

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
  • in children under 12 years of age  
    • 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
    • in children under 12 years of age  

Ask A Doctor Before Use If You Have

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

Stop Use And Ask A Doctor If

  • pain, cough, or nasal congestion 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.

    • nervousness, dizziness, or sleeplessness occurs  
      • pain, cough, or nasal congestion 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.

        • nervousness, dizziness, or sleeplessness occurs  

Keep Out Of Reach Of Children.

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.

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.

Nighttime Cold & Flu Formulawarnings

Liver warning

These products contain acetaminophen. Severe liver damage may occur if you take

  • more than 10 softgels 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.

    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.

    • Do not use to sedate children.

Ask A Doctor Or Pharmacist Before Use If You Are

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

When Using This Product

  • do not exceed recommended dosage 
  • may cause marked drowsiness
  • avoid alcoholic drinks
  • alcohol, sedatives, and tranquilizers may increase drowsiness
  • be careful when driving a motor vehicle or operating machinery
  • excitability may occur, especially in children

Day Cold & Flu Formuladirections

  • do not take more than the recommended dose
  • adults and children 12 years and over: take 2 softgels with water every 4 hours. Do not exceed 10 softgels in 24 hours or as directed by a doctor.
  • children under 12 years: do not use

Nighttime Cold & Flu Formuladirections

  • do not take more than the recommended dose
  • adults and children 12 years and over: take 2 softgels with water every 4 hours. Do not exceed 10 softgels in 24 hours or as directed by a doctor.
  • children under 12 years: do not use

Day Cold & Flu Formulaother Information

  • store at room temperature. Avoid excessive heat.

Nighttime Cold & Flu Formulaother Information

  • store at room temperature. Avoid excessive heat.

Day Cold & Flu Formulainactive Ingredients

FD&C red #40, FD&C yellow #6, gelatin, glycerin, polyethylene glycol,  povidone, propylene glycol, purified water, sorbitol special, and white edible ink

Nighttime Cold & Flu Formulainactive Ingredients

D&C yellow #10, FD&C blue #1, gelatin, glycerin, polyethylene glycol, povidone, propylene glycol, purified water, sorbitol special, and white edible ink

Day Cold & Flu Formulaquestions Or Comments?

Call toll free: 1-855-215-8180

Nighttime Cold & Flu Formulaquestions Or Comments?

Call toll free: 1-855-215-8180

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CVS NON-DROWSY DAY Cold & Flu Plus and NIGHTTIME Cold & Flu Plus 20ct

NDC 69842-069-08

*Compare to the active ingredients in Alka-Seltzer PLUS® Day and Night Cold and Flu Formula

* Please review the disclaimer below.