MedPath

SINUS PAIN AND CONGESTION

CVS 44-466C-SCH

Approved
Approval ID

c878c7aa-c591-4bae-a1d1-842eaf27c5b1

Product Type

HUMAN OTC DRUG LABEL

Effective Date

Sep 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 and Phenylephrine HCl

Product Details

FDA regulatory identification and product classification information

FDA Identifiers
NDC Product Code59779-466
Application NumberM012
Product Classification
M
Marketing Category
C200263
G
Generic Name
Acetaminophen and Phenylephrine HCl
Product Specifications
Route of AdministrationORAL
Effective DateSeptember 18, 2025
FDA Product Classification

INGREDIENTS (18)

ACETAMINOPHENActive
Quantity: 325 mg in 1 1
Code: 362O9ITL9D
Classification: ACTIB
PHENYLEPHRINE HYDROCHLORIDEActive
Quantity: 5 mg in 1 1
Code: 04JA59TNSJ
Classification: ACTIB
STARCH, CORNInactive
Code: O8232NY3SJ
Classification: IACT
CROSPOVIDONE, UNSPECIFIEDInactive
Code: 2S7830E561
Classification: IACT
D&C YELLOW NO. 10 ALUMINUM LAKEInactive
Code: CQ3XH3DET6
Classification: IACT
FD&C BLUE NO. 1 ALUMINUM LAKEInactive
Code: J9EQA3S2JM
Classification: IACT
FD&C RED NO. 40 ALUMINUM LAKEInactive
Code: 6T47AS764T
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
MICROCRYSTALLINE CELLULOSEInactive
Code: OP1R32D61U
Classification: IACT
POLYETHYLENE GLYCOL, UNSPECIFIEDInactive
Code: 3WJQ0SDW1A
Classification: IACT
POLYVINYL ALCOHOL, UNSPECIFIEDInactive
Code: 532B59J990
Classification: IACT
POVIDONE, UNSPECIFIEDInactive
Code: FZ989GH94E
Classification: IACT
SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4
Classification: IACT
SODIUM STARCH GLYCOLATE TYPE A POTATOInactive
Code: 5856J3G2A2
Classification: IACT
STEARIC ACIDInactive
Code: 4ELV7Z65AP
Classification: IACT
SUCRALOSEInactive
Code: 96K6UQ3ZD4
Classification: IACT
TALCInactive
Code: 7SEV7J4R1U
Classification: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JP
Classification: IACT

Drug Labeling Information

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

LOINC: 51945-4Updated: 9/18/2025

Principal Display Panel

♥CVS**™**

actual size****
****** Non-Drowsy**

DAYTIME****
****** SINUS PAIN &******
****** CONGESTION**

Acetaminophen****
****** Pain Reliever, Fever Reducer******
****** Phenylephrine HCl******
****** Nasal Decongestant******


Compare to Tylenol® Sinus + Headache
active ingredients*

Relieves:
Sinus headache,
Sinus pressure &
Nasal congestion

24CAPLETS

TAMPER EVIDENT: DO NOT USE IF
** PACKAGE IS OPENED OR IF BLISTER**
** UNIT IS TORN, BROKEN OR SHOWS**
** ANY SIGNS OF TAMPERING**

*This product is not manufactured or distributed by Kenvue Inc.,
owner of the registered trademark Tylenol® Sinus + Headache.
50844 ORG072146608

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

100% money back
guaranteed.

CVS.com/returnpolicy

CVS 44-466C ORG0721

CVS 44-466C ORG0721

INDICATIONS & USAGE SECTION

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

Uses

  • temporarily relieves these symptoms associated with hay fever or other respiratory allergies, and the common cold:
    • minor aches and pains
    • headache
    • nasal congestion
    • sinus congestion and pressure
  • helps decongest sinus openings and passages
  • promotes sinus drainage
  • helps clear nasal passages
  • temporarily reduces fever

DOSAGE & ADMINISTRATION SECTION

LOINC: 34068-7Updated: 9/18/2025

Directions

*do not take more than directed

  • adults and children 12 years and over
    • take 2 caplets every 4 hours
    • swallow whole - do not crush, chew, or dissolve
    • do not take more than 10 caplets in 24 hours
  • children under 12 years: ask a doctor

OTC - ACTIVE INGREDIENT SECTION

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

Active ingredients (in each caplet)

Acetaminophen 325 mg
Phenylephrine HCl 5 mg

OTC - PURPOSE SECTION

LOINC: 55105-1Updated: 9/18/2025

Purpose

Pain reliever/fever reducer
Nasal decongestant

WARNINGS SECTION

LOINC: 34071-1Updated: 9/18/2025

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 every day while using this product

Allergy alert: Acetaminophen may cause severe skin reactions. Symptoms may include:

  • blisters
  • rash
  • skin reddening

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.
  • 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
  • heart disease
  • diabetes
  • thyroid disease
  • high blood pressure

Ask a doctor or pharmacist before use if you are

taking the blood thinning drug warfarin.

When using this product

do not exceed recommended dosage.

Stop use and ask a doctor if

  • nervousness, dizziness, or sleeplessness occur
  • pain or nasal congestion 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

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 accidental 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.

STORAGE AND HANDLING SECTION

LOINC: 44425-7Updated: 9/18/2025

Other information

*TAMPER EVIDENT: DO NOT USE IF OUTER PACKAGE IS OPENED OR BLISTER IS TORN OR BROKEN

  • store at 25°C (77°F); excursions permitted between 15°-30°C (59°-86°F)
  • see end flap for expiration date and lot number

INACTIVE INGREDIENT SECTION

LOINC: 51727-6Updated: 9/18/2025

Inactive ingredients

corn starch, crospovidone, D&C yellow #10 aluminum lake, FD&C blue #1 aluminum lake, FD&C red #40 aluminum lake, flavor, magnesium stearate, microcrystalline cellulose, polyethylene glycol, polyvinyl alcohol, povidone, silicon dioxide, sodium starch glycolate, stearic acid, sucralose, talc, titanium dioxide

OTC - QUESTIONS SECTION

LOINC: 53413-1Updated: 9/18/2025

Questions or comments?

1-800-426-9391

MedPath

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

© 2025 MedPath, Inc. All rights reserved.

SINUS PAIN AND CONGESTION - FDA Drug Approval Details