Quality Plus 44-453

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 2021-07-14

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 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

Questions Or Comments?

1-800-426-9391

Principal Display Panel

QUALITY

+PLUS

NDC 50844-493-08

*Compare to active ingredient in Sudafed PE® Sinus Congestion

MAXIMUM STRENGTH

SINUS CONGESTION

Phenylephrine HCl 10 mg • NASAL DECONGESTANT

•SINUS PRESSURE

•SINUS CONGESTION

24 Tablets

NON-DROWSY

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 ORG082045308

Distributed by

LNK INTERNATIONAL, INC.

60 Arkay Drive, Hauppauge, NY 11788

USA

Quality Plus 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 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

Questions Or Comments? (Questions or comments?)

1-800-426-9391

Principal Display Panel (Principal display panel)

QUALITY

+PLUS

NDC 50844-493-08

*Compare to active ingredient in Sudafed PE® Sinus Congestion

MAXIMUM STRENGTH

SINUS CONGESTION

Phenylephrine HCl 10 mg • NASAL DECONGESTANT

•SINUS PRESSURE

•SINUS CONGESTION

24 Tablets

NON-DROWSY

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 ORG082045308

Distributed by

LNK INTERNATIONAL, INC.

60 Arkay Drive, Hauppauge, NY 11788

USA

Quality Plus 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

[{"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": "DEXTROSE MONOHYDRATE", "unii": "LX22YL083G", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "DIBASIC CALCIUM PHOSPHATE DIHYDRATE", "unii": "O7TSZ97GEP", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "FD&C RED NO. 40", "unii": "WZB9127XOA", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "LECITHIN, SOYBEAN", "unii": "1DI56QDM62", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "MAGNESIUM STEARATE", "unii": "70097M6I30", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "MALTODEXTRIN", "unii": "7CVR7L4A2D", "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": "CARBOXYMETHYLCELLULOSE SODIUM, UNSPECIFIED", "unii": "K679OBS311", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "TRISODIUM CITRATE DIHYDRATE", "unii": "B22547B95K", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "TITANIUM DIOXIDE", "unii": "15FIX9V2JP", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}]

Raw Label Data

All Sections (JSON)

{"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": "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, 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": "QUALITY +PLUS NDC 50844-493-08 *Compare to active ingredient in Sudafed PE® Sinus Congestion MAXIMUM STRENGTH SINUS CONGESTION Phenylephrine HCl 10 mg • NASAL DECONGESTANT •SINUS PRESSURE •SINUS CONGESTION 24 Tablets NON-DROWSY 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 ORG082045308 Distributed by LNK INTERNATIONAL, INC. 60 Arkay Drive, Hauppauge, NY 11788 USA Quality Plus 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"}

Drug Facts

Composition & Product

Identifiers & Packaging

Medication Information

Structured Label Content

Advanced Ingredient Data

Raw Label Data

Additional Information