MedPath

Night Time Cold and Flu Relief

Drug Facts

Approved
Approval ID

13492631-d5de-4562-a201-664f7d3591de

Product Type

HUMAN OTC DRUG LABEL

Effective Date

Jun 18, 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 HYDROBROMIDE, DOXYLAMINE SUCCINATE

PRODUCT DETAILS

NDC Product Code69842-899
Application NumberM012
Marketing CategoryC200263
Route of AdministrationORAL
Effective DateJune 18, 2025
Generic NameACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATE

INGREDIENTS (16)

ACETAMINOPHENActive
Quantity: 325 mg in 1 1
Code: 362O9ITL9D
Classification: ACTIB
DEXTROMETHORPHAN HYDROBROMIDEActive
Quantity: 15 mg in 1 1
Code: 9D2RTI9KYH
Classification: ACTIB
DOXYLAMINE SUCCINATEActive
Quantity: 6.25 mg in 1 1
Code: V9BI9B5YI2
Classification: ACTIB
D&C YELLOW NO. 10Inactive
Code: 35SW5USQ3G
Classification: IACT
FD&C BLUE NO. 1Inactive
Code: H3R47K3TBD
Classification: IACT
GELATINInactive
Code: 2G86QN327L
Classification: IACT
GLYCERINInactive
Code: PDC6A3C0OX
Classification: IACT
POLYETHYLENE GLYCOL, UNSPECIFIEDInactive
Code: 3WJQ0SDW1A
Classification: IACT
POVIDONEInactive
Code: FZ989GH94E
Classification: IACT
PROPYLENE GLYCOLInactive
Code: 6DC9Q167V3
Classification: IACT
WATERInactive
Code: 059QF0KO0R
Classification: IACT
SORBITANInactive
Code: 6O92ICV9RU
Classification: IACT
SORBITOLInactive
Code: 506T60A25R
Classification: IACT
MANNITOLInactive
Code: 3OWL53L36A
Classification: IACT
LECITHIN, SOYBEANInactive
Code: 1DI56QDM62
Classification: IACT
LIGHT MINERAL OILInactive
Code: N6K5787QVP
Classification: IACT

Drug Labeling Information

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

LOINC: 51945-4Updated: 6/18/2025

Package Label

Acetaminophen 325 mg Dextromethorphan HBr 15 mg Doxylamine Succinate 6,25 mg

CVS Multi-Symptom Nighttime Cold & Flu

INDICATIONS & USAGE SECTION

LOINC: 34067-9Updated: 6/18/2025

Uses

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

OTC - ACTIVE INGREDIENT SECTION

LOINC: 55106-9Updated: 6/18/2025

Active ingredients (in each softgel)

Acetaminophen 325 mg

Dextromethorphan HBr 15 mg

Doxylamine succinate 6.25 mg

OTC - PURPOSE SECTION

LOINC: 55105-1Updated: 6/18/2025

Purpose

** Pain reliever/Fever Reduce**r

Cough suppressant

Antihistamine

WARNINGS SECTION

LOINC: 34071-1Updated: 6/18/2025

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 everyday 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 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 of pharmacist before taking this product.

Ask a doctor before use if you have

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

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

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

Stop use and ask a doctor if

  • 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 or headache that lasts

These could be 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: 6/18/2025

Directions

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

  • do not take more than 4 doses in 24 hours
  • adults and children 12 years and over: take 2 softgels with water every 6 hours
  • swallow whole; do not crush, chew, or dissolve
  • children under 12 years: do not use *when using other Daytime or Nighttime products, carefully read each label to insure correct dosing

OTHER SAFETY INFORMATION

LOINC: 60561-8Updated: 6/18/2025

Other information

  • store between 15-30ºC (59-86ºF)
  • avoid excessive heat

INACTIVE INGREDIENT SECTION

LOINC: 51727-6Updated: 6/18/2025

Inactive ingredients

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: 6/18/2025

Questions or comments?

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

MedPath

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

© 2025 MedPath, Inc. All rights reserved.

Night Time Cold and Flu Relief - FDA Drug Approval Details