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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

FDA regulatory identification and product classification information

FDA Identifiers
NDC Product Code69842-899
Application NumberM012
Product Classification
M
Marketing Category
C200263
G
Generic Name
ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATE
Product Specifications
Route of AdministrationORAL
Effective DateJune 18, 2025
FDA Product Classification

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

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Night Time Cold and Flu Relief - FDA Drug Approval Details