quality choice 44-453

quality choice 44-453
SPL v2
SPL
SPL Set ID 43a77f89-e66a-4db6-8067-f614c0e207df
Route
oral
Published
Effective Date 2025-06-26
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 active Since 2025-06-26

Purpose

Nasal decongestant

Description

Phenylephrine HCl 10 mg


Medication Information

Active Ingredient

Phenylephrine HCl 10 mg

Uses
  • temporarily relieves sinus congestion and pressure
  • temporarily relieves nasal congestion due to the common cold, hay fever or other upper respiratory allergies
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
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, 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

Description

Phenylephrine HCl 10 mg

Principal Display Panel

QUALITY

 CHOICE

NDC 83324-073-36

*Compare to the Active

Ingredient in SUDAFED PE®

SINUS CONGESTION

Maximum Strength | Non-Drowsy

Sinus Congestion PE

Phenylephrine HCl 10 mg

Nasal Decongestant

Sinus Pressure

Sinus Congestion

Does Not Include Pseudoephedrine

Actual Size

36 Tablets

*This product is not manufactured or

distributed by Kenvue Inc., owner of the

registered trademark SUDAFED PE®

SINUS CONGESTION.

50844 REV0820D45307

Distributed by CDMA, Inc.

Novi, MI 48375

www.qualitychoice.com

Questions: 800-935-2362

TAMPER EVIDENT: DO NOT USE IF

PACKAGE IS OPENED OR IF BLISTER

UNIT IS TORN, BROKEN OR SHOWS

ANY SIGNS OF TAMPERING

Quality Choice 44-453 REV0820D

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.

Questions Or Comments?

1-800-426-9391

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.

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

Active Ingredient (Active ingredient (in each tablet))

Phenylephrine HCl 10 mg

Uses
  • temporarily relieves sinus congestion and pressure
  • temporarily relieves nasal congestion due to the common cold, hay fever or other upper respiratory allergies
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
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, 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

Principal Display Panel

QUALITY

 CHOICE

NDC 83324-073-36

*Compare to the Active

Ingredient in SUDAFED PE®

SINUS CONGESTION

Maximum Strength | Non-Drowsy

Sinus Congestion PE

Phenylephrine HCl 10 mg

Nasal Decongestant

Sinus Pressure

Sinus Congestion

Does Not Include Pseudoephedrine

Actual Size

36 Tablets

*This product is not manufactured or

distributed by Kenvue Inc., owner of the

registered trademark SUDAFED PE®

SINUS CONGESTION.

50844 REV0820D45307

Distributed by CDMA, Inc.

Novi, MI 48375

www.qualitychoice.com

Questions: 800-935-2362

TAMPER EVIDENT: DO NOT USE IF

PACKAGE IS OPENED OR IF BLISTER

UNIT IS TORN, BROKEN OR SHOWS

ANY SIGNS OF TAMPERING

Quality Choice 44-453 REV0820D

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.

Questions Or Comments? (Questions or comments?)

1-800-426-9391

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.

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

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