MedPath

Daytime Nighttime Cold Flu Relief

Drug Facts

Approved
Approval ID

df6e522c-3e30-4aa0-8ab9-3b579c80bcad

Product Type

HUMAN OTC DRUG LABEL

Effective Date

May 15, 2025

Manufacturers
FDA

CVS Pharmacy

DUNS: 062312574

Products 1

Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.

Acetaminophen, Dextromethorphan HBr, Doxylamine succinate, Phenylephrine HCl

PRODUCT DETAILS

NDC Product Code69842-896
Application NumberM012
Marketing CategoryC200263
Route of AdministrationN/A
Effective DateMay 15, 2025
Generic NameAcetaminophen, Dextromethorphan HBr, Doxylamine succinate, Phenylephrine HCl

Drug Labeling Information

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

LOINC: 51945-4Updated: 5/15/2025

Product Label

![CVS Daytime and Nighttime Cold & Flu Softgels](/dailymed/image.cfm?name=daytime-pe-nighttime-no-pse-pe-softgels- pur-1.jpg&id=875406)

Daytime and Nighttime Cold & Flu

INDICATIONS & USAGE SECTION

LOINC: 34067-9Updated: 5/15/2025

Uses

DAYTIME

  • temporarily relieves common cold and flu symptoms
    • cough due to minor throat and bronchial irritation
    • nasal congestion
    • headache
    • minor aches and pains
    • fever
    • sore throat

NIGHTTIME

  • temporarily relieves common cold and flu symptoms
    • cough due to minor throat and bronchial irritation
    • sore throat
    • headache
    • minor aches and pains
    • fever
    • runny nose and sneezing

OTC - ACTIVE INGREDIENT SECTION

LOINC: 55106-9Updated: 5/15/2025

Active ingredients for Nighttime (in each softgel)

Acetaminophen 325 mg

Dextromethorphan HBr 15 mg

Doxylamine succinate 6.25 mg

OTC - PURPOSE SECTION

LOINC: 55105-1Updated: 5/15/2025

Purpose for Nighttime

Pain reliever/fever reducer

Cough suppressant

Antihistamine

WARNINGS SECTION

LOINC: 34071-1Updated: 5/15/2025

Warnings

DAYTIME NIGHTTIME

Liver warning: These products contain 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 these products

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

DAYTIME NIGHTTIME

  • 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.

Ask a doctor before use if you have

DAYTIME

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

NIGHTTIME

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

Ask a doctor or pharmacist before use if you are

DAYTIME

taking the blood thinning drug warfarin

NIGHTTIME

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

When using this product,

DAYTIME

do not exceed recommended dosage

NIGHTTIME

*do not exceed recommended dosage

  • excitability may occur, especially in children
  • marked drowsiness may occur
  • avoid alcoholic drinks
  • alcohol, sedatives, and tranquilizers may increase drowsiness
  • be careful when driving a motor vehicle or operating machinery

Stop use and ask a doctor if

DAYTIME

  • nervousness, dizziness or sleeplessness occur
  • pain, cough, and nasal congestion gets worse or lasts more than 7 days
  • redness or swelling is present
  • new symptoms occur
  • fever gets worse or lasts more than 3 days
  • cough comes back or occurs with rash or headache that lasts.

These could be signs of a serious condition.

NIGHTTIME

  • pain 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 headache that lasts.

These could be a signs of a serious condition.

If pregnant or breast-feeding,

ask a health professional before use.

Keep out of reach of children.

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

DOSAGE & ADMINISTRATION SECTION

LOINC: 34068-7Updated: 5/15/2025

Directions

DAYTIME

*do not take more than directed (see Overdose warning)

  • do not take more than 4 doses in 24 hours
  • swallow whole; do not crush, chew, or dissolve
  • adults and children 12 years and over; take 2 softgels with water every 4 hours.
  • children under 12 years: do not use

NIGHTTIME

*do not take more than directed (see Overdose warning)

  • do not take more than 4 doses in 24 hours
  • swallow whole; do not crush, chew, or dissolve
  • adults and children 12 years and over: take 2 softgels with water every 6 hours
  • children under 12 years: do not use

STORAGE AND HANDLING SECTION

LOINC: 44425-7Updated: 5/15/2025

Other information

  • store between 15-30°C (59-86°F)
  • avoid excessive heat

INACTIVE INGREDIENT SECTION

LOINC: 51727-6Updated: 5/15/2025

Inactive ingredients

DAYTIME

FD&C red #40, FD&C yellow #6, gelatin, glycerin, lecithin, light mineral oil, mannitol, polyethylene glycol, povidone, propylene glycol, purified water, sorbitan, sorbitol, white ink

NIGHTTIME

D&C yellow #10, FD&C blue #1, gelatin, glycerin, lecithin, light mineral oil, mannitol, polyethylene glycol, povidone, propylene glycol, purified water, sorbitan, sorbitol, white ink

OTC - QUESTIONS SECTION

LOINC: 53413-1Updated: 5/15/2025

Questions or comments?

Call1-877-753-3935Monday-Friday 9AM-5PM EST

MedPath

Empowering clinical research with data-driven insights and AI-powered tools.

© 2025 MedPath, Inc. All rights reserved.

Daytime Nighttime Cold Flu Relief - FDA Drug Approval Details