Active Ingredient (In Each Tablet)
Pseudoephedrine HCl 30 mg
Nasal Decongestant Tablet, Film Coated
FDA Label NDC 46122-428
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Amerisource Bergen for the product Nasal Decongestant (NDC 46122-428). 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 an MAOI, ask a doctor or pharmacist before taking this product.
Ask A Doctor Before Use If You Have
- thyroid disease
- diabetes
- heart disease
- high blood pressure
- 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.
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 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 |
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 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, 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?
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Compare to Sudafed® Sinus Congestion
active ingredient*
NDC 46122-428-62
MAXIMUM STRENGTH
Nasal Decongestant
pseudoephedrine hydrochloride
(nasal decongestant)
Non-Drowsy/Pseudoephedrine HCl
Relief of:
• Nasal & Sinus Congestion
• Sinus Pressure
24 Tablets | 30 mg Each
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 REV0619A11208
Distributed By
AmerisourceBergen
1300 Morris Drive
Chesterbrook, PA 19087
Questions or Concerns?
www.mygnp.com
Gnp 44-112 (Good Neighbor Pharmacy 44 112 1)
* Please review the disclaimer below.
