Active Ingredient (In Each Tablet)
Pseudoephedrine HCl 30 mg
Nasal Decongestant Tablet, Film Coated
FDA Label NDC 50844-112
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by L.n.k. International, Inc. for the product Nasal Decongestant (NDC 50844-112). This document serves as the official prescribing information, containing essential scientific data and clinical materials required for healthcare providers and patients.
This specific version of the label includes detailed information regarding active ingredient (in each tablet), purpose, uses, do not use, ask a doctor before use if you have, when using this product, stop use and ask a doctor if, if pregnant or breast-feeding,, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Purpose
Nasal decongestant
Uses
- temporarily relieves nasal congestion due to the common cold, hay fever or other upper respiratory allergies
- temporarily relieves sinus congestion and pressure
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 and 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
- trouble urinating due to an enlarged prostate gland
When Using This Product
do not exceed recommended dose.
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.
Directions
adults and children | take 2 tablets every 4 to 6 hours; do not take more than 8 tablets in 24 hours |
| children ages 6 to 12 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 this product in children |
Other Information
- 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, dicalcium phosphate, FD&C red #40 aluminum lake, FD&C yellow #6 aluminum lake, hypromellose, magnesium stearate, microcrystalline cellulose, polydextrose, polyethylene glycol, silica gel, titanium dioxide, triacetin
Questions Or Comments?
1-800-426-9391
Principal Display Panel
NDC 50844-112-22
*Compare to active ingredient in
Sudafed® 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 CARTON IS OPENED OR IF BLISTER
UNIT IS TORN, BROKEN OR SHOWS ANY SIGNS OF TAMPERING
*This product is not manufactured or distributed by
McNeil Consumer Healthcare, owner of the registered
trademark Sudafed® Congestion.
50844 REV0712B11222
Distributed by LNK INTERNATIONAL, INC.
60 Arkay Drive, Hauppauge NY 11788
USA
Quality Plus 44-112 (Quality Plus 44 112 1)
* Please review the disclaimer below.
