Quality Choice 44-453-delisted

Quality Choice 44-453-delisted
SPL v18
SPL
SPL Set ID bf7246c1-90fe-4de8-8bb2-e5ff7e8ca63d
Route
ORAL
Published
Effective Date 2026-01-12
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Phenylephrine (10 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

Identifiers & Packaging

Pill Appearance
Imprint: 44;453 Shape: round Color: red Size: 7 mm Score: 1
Marketing Status
OTC MONOGRAPH DRUG Completed Since 2005-01-14 Until 2027-11-30

Description

Phenylephrine HCl 10 mg

Purpose

Nasal decongestant


Medication Information

Purpose

Nasal decongestant

Description

Phenylephrine HCl 10 mg

Uses
  • temporarily relieves nasal congestion due to the common cold, hay fever or other upper respiratory allergies
  • 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: ask a doctor
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 25ºC (77ºF); excursions permitted between 15º-30ºC (59º-86ºF) 
  • see end flap for expiration date and lot number
Inactive Ingredients

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

Questions Or Comments?

1-800-426-9391

Principal Display Panel

QC®

QUALITY

CHOICE

NDC 63868-144-19

*Compare to the

Active Ingredient in

SUDAFED PE®

SINUS CONGESTION

Non-Drowsy | Maximum Strength

Nasal Decongestant PE

Phenylephrine HCl 10 mg | Nasal Decongestant

Sinus Pressure & Congestion Relief

Does Not Include Pseudoephedrine

18 Tablets

actual size

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.

50844        REV0820C45344

Distributed by C.D.M.A., Inc.©

43157 W 9 Mile Rd

Novi, MI 48375

www.qualitychoice.com

Questions: 800-935-2362

Quality Choice 44-453


When Using This Product

do not exceed recommended dosage.

Stop Use and Ask A Doctor If
  • nervousness, dizziness, or sleeplessness occur
  • symptoms do not improve within 7 days or occur with 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 Ingredient (in Each Tablet)

Phenylephrine HCl 10 mg

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

Structured Label Content

Uses
  • temporarily relieves nasal congestion due to the common cold, hay fever or other upper respiratory allergies
  • 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: ask a doctor
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 (Other information)
  • TAMPER EVIDENT: DO NOT USE IF OUTER PACKAGE IS OPENED OR BLISTER IS TORN OR BROKEN
  • store at 25ºC (77ºF); excursions permitted between 15º-30ºC (59º-86ºF) 
  • see end flap for expiration date and lot number
Inactive Ingredients (Inactive ingredients)

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

Questions Or Comments? (Questions or comments?)

1-800-426-9391

Principal Display Panel

QC®

QUALITY

CHOICE

NDC 63868-144-19

*Compare to the

Active Ingredient in

SUDAFED PE®

SINUS CONGESTION

Non-Drowsy | Maximum Strength

Nasal Decongestant PE

Phenylephrine HCl 10 mg | Nasal Decongestant

Sinus Pressure & Congestion Relief

Does Not Include Pseudoephedrine

18 Tablets

actual size

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.

50844        REV0820C45344

Distributed by C.D.M.A., Inc.©

43157 W 9 Mile Rd

Novi, MI 48375

www.qualitychoice.com

Questions: 800-935-2362

Quality Choice 44-453


When Using This Product (When using this product)

do not exceed recommended dosage.

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 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 Ingredient (in Each Tablet) (Active ingredient (in each tablet))

Phenylephrine HCl 10 mg

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

Advanced Ingredient Data


Raw Label Data

All Sections (JSON)