Quality Plus 44-112

Quality Plus 44-112
SPL v19
SPL
SPL Set ID f12b7f07-0b81-4cab-ae0f-43a7bf9b4bc5
Route
ORAL
Published
Effective Date 2025-09-15
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Pseudoephedrine (30 mg)
Inactive Ingredients
Croscarmellose Sodium Dibasic Calcium Phosphate Dihydrate Fd&c Red No. 40 Aluminum Lake Fd&c Yellow No. 6 Aluminum Lake Hypromellose, Unspecified Magnesium Stearate Microcrystalline Cellulose Polydextrose Polyethylene Glycol, Unspecified Silicon Dioxide Titanium Dioxide Triacetin

Identifiers & Packaging

Pill Appearance
Imprint: 44;112 Shape: round Color: red Size: 7 mm Score: 1
Marketing Status
OTC MONOGRAPH DRUG Active Since 1981-08-25

Description

Pseudoephedrine HCl 30 mg

Purpose

Nasal decongestant


Medication Information

Purpose

Nasal decongestant

Description

Pseudoephedrine HCl 30 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 2 tablets every 4 to 6 hours; do

not take more than 8 tablets in 24

hours 
children ages

6 to 11 years
take 1 tablet every 4 to 6 hours; do not

take more than 4 tablets in 24 hours 

children under 6 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
  • each tablet contains: calcium 15 mg
  • 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, dibasic calcium phosphate dihydrate, FD&C red #40 aluminum lake, FD&C yellow #6 aluminum lake, hypromellose, magnesium stearate, microcrystalline cellulose, polydextrose, polyethylene glycol, silicon dioxide, titanium dioxide, triacetin

Questions Or Comments?

  1-800-426-9391

Principal Display Panel

QUALITY

+PLUS

NDC 50844-112-22

*Compare to active ingredient in

Sudafed® Sinus Congestion

MAXIMUM STRENGTH  NASAL

DECONGESTANT


Pseudoephedrine HCl 30 mg • NASAL DECONGESTANT

• NASAL & SINUS CONGESTION •

• SINUS PRESSURE •

48 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 Kenvue Inc., owner

of the registered trademark Sudafed® Sinus Congestion.

50844 REV0619D11222

Distributed by

LNK INTERNATIONAL, INC.

60 Arkay Drive

Hauppauge, NY 11788

USA

Quality Plus 44-112
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)

Pseudoephedrine HCl 30 mg

Ask A Doctor Before Use If You Have
  • diabetes
  • heart disease
  • high blood pressure
  • thyroid disease
  • 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 2 tablets every 4 to 6 hours; do

not take more than 8 tablets in 24

hours 
children ages

6 to 11 years
take 1 tablet every 4 to 6 hours; do not

take more than 4 tablets in 24 hours 

children under 6 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.

Other Information (Other information)
  • each tablet contains: calcium 15 mg
  • 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, dibasic calcium phosphate dihydrate, FD&C red #40 aluminum lake, FD&C yellow #6 aluminum lake, hypromellose, magnesium stearate, microcrystalline cellulose, polydextrose, polyethylene glycol, silicon dioxide, titanium dioxide, triacetin

Questions Or Comments? (Questions or comments?)

  1-800-426-9391

Principal Display Panel

QUALITY

+PLUS

NDC 50844-112-22

*Compare to active ingredient in

Sudafed® Sinus Congestion

MAXIMUM STRENGTH  NASAL

DECONGESTANT


Pseudoephedrine HCl 30 mg • NASAL DECONGESTANT

• NASAL & SINUS CONGESTION •

• SINUS PRESSURE •

48 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 Kenvue Inc., owner

of the registered trademark Sudafed® Sinus Congestion.

50844 REV0619D11222

Distributed by

LNK INTERNATIONAL, INC.

60 Arkay Drive

Hauppauge, NY 11788

USA

Quality Plus 44-112
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))

Pseudoephedrine HCl 30 mg

Ask A Doctor Before Use If You Have (Ask a doctor before use if you have)
  • diabetes
  • heart disease
  • high blood pressure
  • thyroid disease
  • difficulty in urination due to enlargement of the prostate gland

Advanced Ingredient Data


Raw Label Data

All Sections (JSON)