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Drug Facts
Mfd. for:
Rugby Laboratories, Inc.
Duluth, Georgia 30097
Rugby Nasal Decongestant
FDA Label NDC 68258-8000
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Dispensing Solutions, Inc. for the product Rugby Nasal Decongestant (NDC 68258-8000). 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 other, active ingredient (in each teaspoonful [tsp]), purpose, uses, otc - do not use, otc - ask doctor, when using this product, stop use and ask a doctor if, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Active Ingredient (In Each Teaspoonful [Tsp])
Pseudoephedrine HCl 30 mg
Purpose
Nasal decongestant
Uses
temporarily relieves nasal congestion due to
- common cold
- hay fever
- upper respiratory allergies
Otc - Do Not Use
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 two weeks after stopping the MAOI drug. If you do not know if your prescription drug contains an MAOI, ask your doctor or pharmacist before taking this product.
Otc - Ask Doctor
Ask a doctor before use if you have
- heart disease
- thyroid disease
- diabetes
- high blood pressure
- 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
- you get nervous, dizzy or sleepless
- symptoms do not improve within 7 days or occur with fever
Otc - Pregnancy Or Breast Feeding
If pregnant or breast-feeding, ask a health professional before use.
Otc - Keep Out Of Reach Of Children
Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center right away.
Directions
- take every 4-6 hours
- do not take more than 4 doses in 24 hours
- use only with enclosed dose cup. Do not use with any other device.
| adults & children 12 years and over | 2 TSP |
| children 6 to under 12 years | 1 TSP |
| children under 6 years | do not use |
Other Information
- store at room temperature 15°-30°C (59°-86°F)
- protect from light
Inactive Ingredients
artificial raspberry flavor, citric acid, FD&C red #40, glycerin, methylparaben, purified water, saccharin sodium, sodium benzoate, sorbitol solution
Questions Or Comments?
Call 1-800-645-2158, 9 am - 5 pm ET, Monday - Friday
Principal Display Panel
NDC 68258-8000-04
NASAL DECONGESTANT
LIQUID
Pseudoephedrine HCl 30 mg
TEMPORARILY RELIEVES NASAL CONGESTION DUE TO COLDS AND ALLERGIES WITHOUT DROWSINESS
•SATISFACTION GUARANTEED•
4 fl oz
(118 mL)
* Please review the disclaimer below.
