Nasal Decongestant
Quality Plus 44-112
f12b7f07-0b81-4cab-ae0f-43a7bf9b4bc5
HUMAN OTC DRUG LABEL
Aug 13, 2025
L.N.K. International, Inc.
DUNS: 038154464
Products 1
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
Pseudoephedrine HCl
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
Product Classification
Product Specifications
INGREDIENTS (13)
Drug Labeling Information
PACKAGE LABEL.PRINCIPAL DISPLAY PANEL
Principal Display Panel
QUALITY
** +PLUS**
NDC 50844-112-46
*Compare to active ingredient in
Sudafed® Sinus Congestion
MAXIMUM STRENGTH****
** NASAL**
** DECONGESTANT**
Pseudoephedrine HCl 30 mg • NASAL DECONGESTANT
• NASAL & SINUS CONGESTION •
** • SINUS PRESSURE •**
96 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® Sinus Congestion.
50844 REV0619A11246
Distributed byLNK INTERNATIONAL, INC.
****60 Arkay Drive,
Hauppauge, NY 11788
USA
Quality Plus 44-112
INDICATIONS & USAGE SECTION
Uses
- temporarily relieves nasal congestion due to the common cold, hay fever or other upper respiratory allergies
- temporarily relieves sinus congestion and pressure
OTC - ACTIVE INGREDIENT SECTION
Active ingredient (in each tablet)
Pseudoephedrine HCl 30 mg
OTC - PURPOSE SECTION
Purpose
Nasal decongestant
WARNINGS SECTION
Warnings
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.
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
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.
DOSAGE & ADMINISTRATION SECTION
Directions
|
adults and children |
take 2 tablets every 4 to 6 hours; do |
|
children ages |
take 1 tablet every 4 to 6 hours; do not |
|
children under 6 years |
do not use |
STORAGE AND HANDLING SECTION
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 INGREDIENT SECTION
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
OTC - QUESTIONS SECTION
Questions or comments?
****1-800-426-9391