MedPath

Nighttime HBP Cold and Flu Relief

CVS 44-013 HBP

Approved
Approval ID

146c9a62-0418-4b5d-9074-5be8a05f3f93

Product Type

HUMAN OTC DRUG LABEL

Effective Date

Aug 12, 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

Product Details

FDA regulatory identification and product classification information

FDA Identifiers
NDC Product Code69842-086
Application NumberM012
Product Classification
M
Marketing Category
C200263
G
Generic Name
Acetaminophen, Dextromethorphan HBr, Doxylamine succinate
Product Specifications
Route of AdministrationORAL
Effective DateAugust 12, 2025
FDA Product Classification

INGREDIENTS (16)

ACETAMINOPHENActive
Quantity: 650 mg in 30 mL
Code: 362O9ITL9D
Classification: ACTIB
DEXTROMETHORPHAN HYDROBROMIDEActive
Quantity: 30 mg in 30 mL
Code: 9D2RTI9KYH
Classification: ACTIB
DOXYLAMINE SUCCINATEActive
Quantity: 12.5 mg in 30 mL
Code: V9BI9B5YI2
Classification: ACTIB
ANHYDROUS CITRIC ACIDInactive
Code: XF417D3PSL
Classification: IACT
FD&C BLUE NO. 1Inactive
Code: H3R47K3TBD
Classification: IACT
FD&C RED NO. 40Inactive
Code: WZB9127XOA
Classification: IACT
GLYCERINInactive
Code: PDC6A3C0OX
Classification: IACT
HIGH FRUCTOSE CORN SYRUPInactive
Code: XY6UN3QB6S
Classification: IACT
POLYETHYLENE GLYCOL 400Inactive
Code: B697894SGQ
Classification: IACT
PROPYLENE GLYCOLInactive
Code: 6DC9Q167V3
Classification: IACT
WATERInactive
Code: 059QF0KO0R
Classification: IACT
SODIUM BENZOATEInactive
Code: OJ245FE5EU
Classification: IACT
SODIUM CHLORIDEInactive
Code: 451W47IQ8X
Classification: IACT
TRISODIUM CITRATE DIHYDRATEInactive
Code: B22547B95K
Classification: IACT
SACCHARIN SODIUMInactive
Code: SB8ZUX40TY
Classification: IACT
SUCRALOSEInactive
Code: 96K6UQ3ZD4
Classification: IACT

Drug Labeling Information

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

LOINC: 51945-4Updated: 8/12/2025

Principal display panel

NDC 69842-086-02

♥︎CVS**™**

Cherry Flavor

Nighttime****
** HIGH BLOOD**
** PRESSURE**
** COLD & FLU**

Acetaminophen
Pain Reliever, Fever Reducer
****Dextromethorphan HBr
Cough Suppressant
Doxylamine Succinate
Antihistamine

Compare to Vicks® NyQuil™
High Blood Pressure Cold & Flu
active ingredients*

Decongestant Free for People
with High Blood Pressure

Multi-Symptom Relief: Aches & fever,
Runny nose, Sneezing, Cough

12 FL OZ (355 mL)

Ages 12 Years
** & Older**

TAMPER EVIDENT: DO NOT USE IF PRINTED
** NECK WRAP IS BROKEN OR MISSING**

*This product is not manufactured or
distributed by The Procter & Gamble
Company, owner of the registered
trademark Vicks® NyQuil™ High Blood
Pressure Cold & Flu.

Distributed by:
** CVS Pharmacy, Inc.**
One CVS Drive
Woonsocket, RI 02895
© 2025 CVS/pharmacy
CVS.com®
1-800-SHOP CVS
V-19849

50844 ORG032301302

PARENTS:
Learn about teen medicine abuse
www.StopMedicineAbuse.org

CVS 44-013

CVS 44-013

INDICATIONS & USAGE SECTION

LOINC: 34067-9Updated: 8/12/2025

Uses

  • temporarily relieves common cold and flu symptoms:

    • headache
    • minor aches and pains
    • sore throat
    • runny nose and sneezing
    • cough due to minor throat and bronchial irritation
  • temporarily reduces fever

OTC - ACTIVE INGREDIENT SECTION

LOINC: 55106-9Updated: 8/12/2025

Active ingredients (in each 30 mL)

Acetaminophen 650 mg
Dextromethorphan HBr 30 mg
Doxylamine succinate 12.5 mg

OTC - PURPOSE SECTION

LOINC: 55105-1Updated: 8/12/2025

Purpose

Pain reliever/fever reducer
Cough suppressant
Antihistamine

WARNINGS SECTION

LOINC: 34071-1Updated: 8/12/2025

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 every day 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 for 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 or pharmacist before taking this product.
  • if you have ever had an allergic reaction to this product or any of its ingredients

Ask a doctor before use if you have

  • difficulty in urination due to enlargement of the prostate gland
  • liver disease
  • glaucoma
  • a breathing problem or chronic cough that lasts or 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

  • excitability may occur, especially in children
  • avoid alcoholic beverages
  • marked drowsiness may occur
  • alcohol, sedatives, and tranquilizers may increase drowsiness
  • use caution 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
  • redness or swelling is present
  • fever gets worse or lasts more than 3 days
  • 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.

In case of overdose, get medical help or contact a Poison Control Center right away. Prompt 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: 8/12/2025

Directions

*do not take more than directed

  • do not exceed 4 doses per 24 hours
  • mL = milliliter
  • only use the dose cup provided
  • adults and children 12 years and over: 30 mL every 6 hours
  • children under 12 years: do not use

STORAGE AND HANDLING SECTION

LOINC: 44425-7Updated: 8/12/2025

Other information

*each 30 mL contains: sodium 13 mg

  • store at 25°C (77°F); excursions permitted between 15°-30°C (59°-86°F)
  • use by expiration date on package

INACTIVE INGREDIENT SECTION

LOINC: 51727-6Updated: 8/12/2025

Inactive ingredients

anhydrous citric acid, FD&C blue #1, FD&C red #40, flavor, glycerin, high fructose corn syrup, polyethylene glycol 400, propylene glycol, purified water, sodium benzoate, sodium chloride, sodium citrate dihydrate, sodium saccharin, sucralose

OTC - QUESTIONS SECTION

LOINC: 53413-1Updated: 8/12/2025

Questions or comments?

1-800-426-9391

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Nighttime HBP Cold and Flu Relief - FDA Drug Approval Details