Drug Facts
Pseudoephedrine Hydrochloride 30 mg
Nasal Decongestant Tablet
FDA Label NDC 0536-3607
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Rugby Laboratories for the product Nasal Decongestant (NDC 0536-3607). 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 drug facts, 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 Congestant
Uses
- temporarily relieves nasal congestion due to the common cold, hay fever or other upper respiratory allergies
- temporarily restores freer breathing through the nose
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 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
- heart disease
- high blood pressure
- thyroid disease
- diabetes
- trouble urinating due to an enlarged prostate gland
When Using This Product
- do not use more than directed
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 (1-800-222-1222).
Directions
| adults and children 12 years and older | 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 |
Other Information
- store at room temperature
Inactive Ingredients
Calcium sulfate, carnauba wax, croscarmellose sodium, FD&C red #40 lake, FD&C yellow #6 lake, gelatin, kaolin, lactose, magnesium silicate, magnesium stearate, microcrystalline cellulose, pharmaceutical glaze, silica, stearic acid, sugar and titanium dioxide
Questions Or Comments?
1-800-645-2158
Other
*Rugby Laboratories is not affiliated with the owner of the registered trademark Sudafed®
SAFETY SEALED: DO NOT USE IF BLISTER SEAL IS BROKEN
Distributed by:
Rugby Laboratories
17177 N Laurel Park Drive, Suite 233
Livonia, MI 48152
www.rugbylaboratories.com
Re-order No. 370277
Rev. 03/17 R-29
Package Label.Principal Display Panel
Rugby®
Compare to active ingredient in Sudafed®
NDC 0536-3607-35
Nasal Decongestant
Pseudoephedrine HCl 30 mg
Temporarily relieves nasal congestion due to cold & allergies without drowsiness
24 tablets
1004 Label (1004 24bb 8491 Ifc Nasal Decongestant Rugby)
* Please review the disclaimer below.
