Active Ingredient (In Each Tablet)
Pseudoephedrine HCl 30 mg
Nasal Decongestant Tablet, Film Coated
FDA Label NDC 63868-802
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Chain Drug Marketing Association Inc for the product Nasal Decongestant (NDC 63868-802). 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
- heart disease
- diabetes
- thyroid 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 (1-800-222-1222) right away.
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 |
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?
1-800-426-9391
Principal Display Panel
QC®
QUALITY
CHOICE
NDC 63868-802-48
*Compare to the active ingredient in SUDAFED® SINUS CONGESTION
Maximum Strength | Non-Drowsy
Nasal Decongestant
Pseudoephedrine HCl 30 mg
Nasal Decongestant
Sinus Pressure
Sinus Congestion
actual
size
48 Tablets (30 mg each)
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 REV0619A11222
Distributed by C.D.M.A., Inc.©
43157 W 9 Mile
Novi, MI 48375
www.qualitychoice.com
Questions: 800-935-2362
SATISFACTION
100% QC
GUARANTEED
Quality Choice 44-112 (Quality Choice 44 112 1)
* Please review the disclaimer below.
