Cvs 44-453485

SPL v9

SPL

SPL Set ID 5734844f-0e94-4fc8-b17c-ca3285dc62c9

Route

ORAL

Published

Effective Date 2025-07-21

Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients

Phenylephrine (10 mg) Diphenhydramine (25 mg)

Inactive Ingredients

Croscarmellose Sodium Dextrose Monohydrate Dibasic Calcium Phosphate Dihydrate Fd&c Red No. 40 Lecithin, Soybean Magnesium Stearate Maltodextrin Microcrystalline Cellulose Silicon Dioxide Carboxymethylcellulose Sodium, Unspecified Trisodium Citrate Dihydrate Titanium Dioxide Fd&c Blue No. 1 Aluminum Lake Hypromellose, Unspecified Polydextrose Polyethylene Glycol, Unspecified Stearic Acid Triacetin

Identifiers & Packaging

Pill Appearance

Imprint: 44;485 Shape: round Shape: oval Color: red Color: blue Size: 7 mm Size: 11 mm Score: 1

Marketing Status

OTC MONOGRAPH DRUG Active Since 2019-06-10

Description

Phenylephrine HCl 10 mg

Purpose

Nasal decongestant

Medication Information

Purpose

Nasal decongestant

Description

Phenylephrine HCl 10 mg

Uses

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

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.
with any other product containing diphenhydramine, even one used on skin (Nighttime only)

Other Information

each tablet contains: calcium 25 mg (Nighttime only)
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

Questions Or Comments?

1-800-426-9391

Principal Display Panel

♥CVSHealth®

Compare to the active ingredients in

Sudafed PE® Sinus Congestion Daytime and Nighttime*

DAYTIME - Non-Drowsy

Sinus

Congestion PE

PHENYLEPHRINE HCI

Nasal decongestant

Relieves:

Nasal congestion

Actual Size

12 TABLETS

NIGHTTIME

Sinus

Congestion PE

DIPHENHYDRAMINE HCI

Antihistamine

PHENYLEPHRINE HCI

Nasal decongestant

Relieves:

Nasal congestion

Runny nose

Actual Size

8 TABLETS

20 TOTAL TABLETS

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 Johnson & Johnson Corporation,

owner of the registered trademark Sudafed PE® Sinus Congestion Daytime and

Nighttime. 50844 REV0820B45348509

Distributed by: CVS Pharmacy, Inc.

One CVS Drive, Woonsocket, RI 02895

© 2021 CVS/pharmacy

CVS.com® 1-800-SHOP CVS

V-19849

CVS® Quality

Money Back Guarantee

CVS Health 44-453485

When Using This Product

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

Stop Use and Ask A Doctor If

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

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.

Read each section carefully. Do not take DAYTIME and NIGHTTIME products at the same time.

Ask A Doctor Before Use If You Have

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

Inactive Ingredients (daytime Only)

croscarmellose sodium, dextrose monohydrate, dibasic calcium phosphate dihydrate, FD&C red #40, lecithin, magnesium stearate, maltodextrin, microcrystalline cellulose, silicon dioxide, sodium carboxymethylcellulose, sodium citrate dihydrate, titanium dioxide

Inactive Ingredients (nighttime Only)

croscarmellose sodium, dibasic calcium phosphate dihydrate, FD&C blue #1 aluminum lake, hypromellose, magnesium stearate, microcrystalline cellulose, polydextrose, polyethylene glycol, silicon dioxide, stearic acid, titanium dioxide, triacetin

Active Ingredient (in Each Tablet) (sinus Day)

Phenylephrine HCl 10 mg

Ask A Doctor Or Pharmacist Before Use If You Are

taking sedatives or tranquilizers. (Nighttime only)

Active Ingredients (in Each Tablet) (sinus Night)

Diphenhydramine HCl 25 mg

Phenylephrine HCl 10 mg

Structured Label Content

Uses

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

Purpose

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 (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.
with any other product containing diphenhydramine, even one used on skin (Nighttime only)

Other Information (Other information)

each tablet contains: calcium 25 mg (Nighttime only)
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

Questions Or Comments? (Questions or comments?)

1-800-426-9391

Principal Display Panel (Principal display panel)

♥CVSHealth®

Compare to the active ingredients in

Sudafed PE® Sinus Congestion Daytime and Nighttime*

DAYTIME - Non-Drowsy

Sinus

Congestion PE

PHENYLEPHRINE HCI

Nasal decongestant

Relieves:

Nasal congestion

Actual Size

12 TABLETS

NIGHTTIME

Sinus

Congestion PE

DIPHENHYDRAMINE HCI

Antihistamine

PHENYLEPHRINE HCI

Nasal decongestant

Relieves:

Nasal congestion

Runny nose

Actual Size

8 TABLETS

20 TOTAL TABLETS

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 Johnson & Johnson Corporation,

owner of the registered trademark Sudafed PE® Sinus Congestion Daytime and

Nighttime. 50844 REV0820B45348509

Distributed by: CVS Pharmacy, Inc.

One CVS Drive, Woonsocket, RI 02895

© 2021 CVS/pharmacy

CVS.com® 1-800-SHOP CVS

V-19849

CVS® Quality

Money Back Guarantee

CVS Health 44-453485

When Using This Product (When using this product)

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

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

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

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.

Read each section carefully. Do not take DAYTIME and NIGHTTIME products at the same time.

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

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

Inactive Ingredients (daytime Only) (Inactive ingredients (Daytime only))

Inactive Ingredients (nighttime Only) (Inactive ingredients (Nighttime only))

Active Ingredient (in Each Tablet) (sinus Day) (Active ingredient (in each tablet) (Sinus Day))

Phenylephrine HCl 10 mg

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

taking sedatives or tranquilizers. (Nighttime only)

Active Ingredients (in Each Tablet) (sinus Night) (Active ingredients (in each tablet) (Sinus Night))

Diphenhydramine HCl 25 mg

Phenylephrine HCl 10 mg

Advanced Ingredient Data

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{"name": "TRIACETIN", "unii": "XHX3C3X673", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}]

Raw Label Data

All Sections (JSON)

{"Uses": "temporarily relieves these symptoms due to hay fever or other upper respiratory allergies: nasal congestion sneezing (Nighttime only) runny nose (Nighttime only) itchy, watery eyes (Nighttime only) itching of the nose or throat (Nighttime only) temporarily relieves these symptoms due to the common cold: nasal congestion sneezing (Nighttime only) runny nose (Nighttime only) temporarily relieves sinus congestion and pressure", "Purpose": "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. with any other product containing diphenhydramine, even one used on skin (Nighttime only)", "Other information": "each tablet contains: calcium 25 mg (Nighttime only) 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", "Questions or comments?": "1-800-426-9391", "Principal display panel": "♥CVS Health® Compare to the active ingredients in Sudafed PE® Sinus Congestion Daytime and Nighttime* DAYTIME - Non-Drowsy Sinus Congestion PE PHENYLEPHRINE HCI Nasal decongestant Relieves: Nasal congestion Actual Size 12 TABLETS NIGHTTIME Sinus Congestion PE DIPHENHYDRAMINE HCI Antihistamine PHENYLEPHRINE HCI Nasal decongestant Relieves: Nasal congestion Runny nose Actual Size 8 TABLETS 20 TOTAL TABLETS 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 Johnson & Johnson Corporation, owner of the registered trademark Sudafed PE® Sinus Congestion Daytime and Nighttime. 50844 REV0820B45348509 Distributed by: CVS Pharmacy, Inc. One CVS Drive, Woonsocket, RI 02895 © 2021 CVS/pharmacy CVS.com® 1-800-SHOP CVS V-19849 CVS® Quality Money Back Guarantee CVS Health 44-453485", "When using this product": "do not exceed recommended dosage excitability may occur, especially in children (Nighttime only) marked drowsiness may occur (Nighttime only) alcohol, sedatives, and tranquilizers may increase drowsiness (Nighttime only) avoid alcoholic beverages (Nighttime only) use caution when driving a motor vehicle or operating machinery (Nighttime only)", "Stop use and ask a doctor if": "symptoms do not improve within 7 days or occur with fever nervousness, dizziness, or sleeplessness occur", "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. Read each section carefully. Do not take DAYTIME and NIGHTTIME products at the same time.", "Ask a doctor before use if you have": "heart disease diabetes thyroid disease high blood pressure difficulty in urination due to enlargement of the prostate gland a breathing problem such as emphysema or chronic bronchitis (Nighttime only) glaucoma (Nighttime only)", "Inactive ingredients (Daytime only)": "croscarmellose sodium, dextrose monohydrate, dibasic calcium phosphate dihydrate, FD&C red #40, lecithin, magnesium stearate, maltodextrin, microcrystalline cellulose, silicon dioxide, sodium carboxymethylcellulose, sodium citrate dihydrate, titanium dioxide", "Inactive ingredients (Nighttime only)": "croscarmellose sodium, dibasic calcium phosphate dihydrate, FD&C blue #1 aluminum lake, hypromellose, magnesium stearate, microcrystalline cellulose, polydextrose, polyethylene glycol, silicon dioxide, stearic acid, titanium dioxide, triacetin", "Active ingredient (in each tablet) (Sinus Day)": "Phenylephrine HCl 10 mg", "Ask a doctor or pharmacist before use if you are": "taking sedatives or tranquilizers. (Nighttime only)", "Active ingredients (in each tablet) (Sinus Night)": "Diphenhydramine HCl 25 mg Phenylephrine HCl 10 mg"}

Additional Information

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Source: dailymed · Ingested: 2026-02-15T12:06:34.923867 · Updated: 2026-03-14T23:09:26.831955