Cvs 44-462 - DailyMed Details

Cvs 44-462

SPL v15

SPL

SPL Set ID b389f438-08d3-44e0-86a4-e34d12f018f8

Route

ORAL

Published

Effective Date 2025-10-29

Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients

Chlorpheniramine (4 mg) Phenylephrine (10 mg)

Inactive Ingredients

Croscarmellose Sodium Anhydrous Lactose Magnesium Stearate Microcrystalline Cellulose Silicon Dioxide Stearic Acid

Identifiers & Packaging

Pill Appearance

Imprint: 44;462 Shape: round Color: white Size: 7 mm Score: 1

Marketing Status

OTC MONOGRAPH DRUG Active Since 2005-06-09

Description

Chlorpheniramine maleate 4 mg Phenylephrine HCl 10 mg

Purpose

Antihistamine Nasal decongestant

Medication Information

Purpose

Antihistamine

Nasal decongestant

Description

Chlorpheniramine maleate 4 mg Phenylephrine HCl 10 mg

Uses

temporarily relieves these symptoms due to hay fever (allergic rhinitis) or other upper respiratory allergies:
- itchy, watery eyes
- runny nose
- itching of the nose or throat
- nasal congestion
- sneezing
- sinus congestion and pressure

Warnings

Directions

adults and children 12 years and over: take 1 tablet every 4 hours. Do not take more than 6 tablets in 24 hours.
children under 12 years: do not use

Do Not Use

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.

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 Ingredients

croscarmellose sodium, lactose anhydrous, magnesium stearate, microcrystalline cellulose, silicon dioxide, stearic acid

Questions Or Comments?

1-800-426-9391

Principal Display Panel

♥︎CVS_™

NDC 59779-962-08

actual size

Maximum Strength^†

SINUS PE + ALLERGY

Chlorpheniramine Maleate, Antihistamine

Phenylephrine Hydrochloride, Nasal Decongestant

Relieves: Sinus pressure & congestion,

Sneezing, Itchy eyes, Runny nose

^†Under OTC monograph.

24

TABLETS

TAMPER EVIDENT: DO NOT

USE IF PACKAGE IS OPENED

OR IF BLISTER UNIT IS

TORN, BROKEN OR SHOWS

ANY SIGNS OF TAMPERING

50844 ORG031946208

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 44-462

When Using This Product

do not exceed recommended dosage
excitability may occur, especially in children
drowsiness may occur
avoid alcoholic beverages
alcohol, sedatives and tranquilizers may increase drowsiness
use caution when driving a motor vehicle or operating machinery

Stop Use and Ask A Doctor If

nervousness, dizziness, or sleeplessness occur
symptoms do not improve within 7 days or occur with a fever

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.

Active Ingredients (in Each Tablet)

Chlorpheniramine maleate 4 mg

Phenylephrine HCl 10 mg

Ask A Doctor Before Use If You Have

high blood pressure
heart disease
thyroid disease
diabetes
glaucoma
difficulty in urination due to enlargement of the prostate gland
a breathing problem such as emphysema or chronic bronchitis

Ask A Doctor Or Pharmacist Before Use If You Are

taking sedatives or tranquilizers.

Structured Label Content

Uses

temporarily relieves these symptoms due to hay fever (allergic rhinitis) or other upper respiratory allergies:
- itchy, watery eyes
- runny nose
- itching of the nose or throat
- nasal congestion
- sneezing
- sinus congestion and pressure

Purpose

Antihistamine

Nasal decongestant

Warnings

Directions

adults and children 12 years and over: take 1 tablet every 4 hours. Do not take more than 6 tablets in 24 hours.
children under 12 years: do not use

Do Not Use (Do not use)

Other Information (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 Ingredients (Inactive ingredients)

croscarmellose sodium, lactose anhydrous, magnesium stearate, microcrystalline cellulose, silicon dioxide, stearic acid

Questions Or Comments? (Questions or comments?)

1-800-426-9391

Principal Display Panel (Principal display panel)

♥︎CVS_™

NDC 59779-962-08

actual size

Maximum Strength^†

SINUS PE + ALLERGY

Chlorpheniramine Maleate, Antihistamine

Phenylephrine Hydrochloride, Nasal Decongestant

Relieves: Sinus pressure & congestion,

Sneezing, Itchy eyes, Runny nose

^†Under OTC monograph.

24

TABLETS

TAMPER EVIDENT: DO NOT

USE IF PACKAGE IS OPENED

OR IF BLISTER UNIT IS

TORN, BROKEN OR SHOWS

ANY SIGNS OF TAMPERING

50844 ORG031946208

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 44-462

When Using This Product (When using this product)

do not exceed recommended dosage
excitability may occur, especially in children
drowsiness may occur
avoid alcoholic beverages
alcohol, sedatives and tranquilizers may increase drowsiness
use caution when driving a motor vehicle or operating machinery

Stop Use and Ask A Doctor If (Stop use and ask a doctor if)

nervousness, dizziness, or sleeplessness occur
symptoms do not improve within 7 days or occur with a fever

If Pregnant Or Breast Feeding, (If pregnant or breast-feeding,)

ask a health professional before use.

Keep Out of Reach of Children. (Keep out of reach of children.)

In case of overdose, get medical help or contact a Poison Control Center right away.

Active Ingredients (in Each Tablet) (Active ingredients (in each tablet))

Chlorpheniramine maleate 4 mg

Phenylephrine HCl 10 mg

Ask A Doctor Before Use If You Have (Ask a doctor before use if you have)

high blood pressure
heart disease
thyroid disease
diabetes
glaucoma
difficulty in urination due to enlargement of the prostate gland
a breathing problem such as emphysema or chronic bronchitis

Ask A Doctor Or Pharmacist Before Use If You Are (Ask a doctor or pharmacist before use if you are)

taking sedatives or tranquilizers.

Advanced Ingredient Data

[{"name": "CHLORPHENIRAMINE", "unii": "3U6IO1965U", "classCode": "ACTIB", "strengthNumerator": "4", "strengthDenominator": "1", "strengthNumeratorUnit": "mg", "strengthDenominatorUnit": "1"}, {"name": "PHENYLEPHRINE", "unii": "1WS297W6MV", "classCode": "ACTIB", "strengthNumerator": "10", "strengthDenominator": "1", "strengthNumeratorUnit": "mg", "strengthDenominatorUnit": "1"}, {"name": "CROSCARMELLOSE SODIUM", "unii": "M28OL1HH48", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "ANHYDROUS LACTOSE", "unii": "3SY5LH9PMK", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "MAGNESIUM STEARATE", "unii": "70097M6I30", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "MICROCRYSTALLINE CELLULOSE", "unii": "OP1R32D61U", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "SILICON DIOXIDE", "unii": "ETJ7Z6XBU4", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "STEARIC ACID", "unii": "4ELV7Z65AP", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}]

Raw Label Data

All Sections (JSON)

{"Uses": "temporarily relieves these symptoms due to hay fever (allergic rhinitis) or other upper respiratory allergies: itchy, watery eyes runny nose itching of the nose or throat nasal congestion sneezing sinus congestion and pressure", "Purpose": "Antihistamine Nasal decongestant", "Directions": "adults and children 12 years and over: take 1 tablet every 4 hours. Do not take more than 6 tablets in 24 hours. children under 12 years: do not use", "Do not use": "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.", "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 ingredients": "croscarmellose sodium, lactose anhydrous, magnesium stearate, microcrystalline cellulose, silicon dioxide, stearic acid", "Questions or comments?": "1-800-426-9391", "Principal display panel": "♥︎CVS ™ NDC 59779-962-08 actual size Maximum Strength † SINUS PE + ALLERGY Chlorpheniramine Maleate, Antihistamine Phenylephrine Hydrochloride, Nasal Decongestant Relieves: Sinus pressure & congestion, Sneezing, Itchy eyes, Runny nose † Under OTC monograph. 24 TABLETS TAMPER EVIDENT: DO NOT USE IF PACKAGE IS OPENED OR IF BLISTER UNIT IS TORN, BROKEN OR SHOWS ANY SIGNS OF TAMPERING 50844 ORG031946208 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 44-462", "When using this product": "do not exceed recommended dosage excitability may occur, especially in children drowsiness may occur avoid alcoholic beverages alcohol, sedatives and tranquilizers may increase drowsiness use caution when driving a motor vehicle or operating machinery", "Stop use and ask a doctor if": "nervousness, dizziness, or sleeplessness occur symptoms do not improve within 7 days or occur with a fever", "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.", "Active ingredients (in each tablet)": "Chlorpheniramine maleate 4 mg Phenylephrine HCl 10 mg", "Ask a doctor before use if you have": "high blood pressure heart disease thyroid disease diabetes glaucoma difficulty in urination due to enlargement of the prostate gland a breathing problem such as emphysema or chronic bronchitis", "Ask a doctor or pharmacist before use if you are": "taking sedatives or tranquilizers."}

Additional Information

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Source: dailymed · Ingested: 2026-02-15T12:06:06.475582 · Updated: 2026-03-14T23:13:20.000214