Maximum Strength Nighttime Cold/flu Relief
FDA Label NDC 69842-071

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 Maximum Strength Nighttime Cold/flu Relief (NDC 69842-071). 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 ingredient (in each softgel), purposes, uses, warnings, do not use, directions, other information, inactive ingredients, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Label Section Quick Index

Active Ingredient (In Each Softgel)

Acetaminophen 325 mg

Dextromethorphan HBr 10 mg

Doxylamine succinate 6.25 mg

Phenylephrine HCl 5 mg

Purposes

Pain reliever/ fever reducer

Cough suppressant

Antihistamine

Nasal decongestant

Uses

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

Warnings

Liver warningThis product contains acetaminophen. Severe liver damage may occur if you take

  • more than 4 doses in 24 hrs, 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.
  • to make a child sleep

Directions

  • take only as directed - see Overdose Warning
  • do not exceed 4 doses per 24 hrs

    • adults & children 12 yrs and over

            2 softgels with water every 4 hrs

    children 4 to under 12 yrs 

            ask a doctor

    children under 4 yrs 

            do not use

    • when using other Nighttime or Daytime products, carefully read each label to ensure correct dosing

Other Information

  • store at room temperature and avoid excessive heat

Inactive Ingredients

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

Principal Display Panel

Maximum Strength

Nighttime Cold/Flu Relief

NDC 69842-071-04

24 Softgels

Nighttime-cold-flu-carton (Nighttime Cold Flu 24ct)

Nighttime-cold-flu-carton (Nighttime Cold Flu 24ct)

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