FDA Label for Rugby Nasal Decongestant

View Indications, Usage & Precautions

Rugby Nasal Decongestant Product Label

The following document was submitted to the FDA by the labeler of this product A-s Medication Solutions. The document includes published materials associated whith this product with the essential scientific information about this product as well as other prescribing information. Product labels may durg indications and usage, generic names, contraindications, active ingredients, strength dosage, routes of administration, appearance, warnings, inactive ingredients, etc.

Other



Drug Facts

Distributed by: Rugby Laboratories
17177 N Laurel Park Drive, Suite 233,
Livonia, MI, 48152


Active Ingredient (In Each Teaspoonful)



Pseudoephedrine HCl 30 mg


Purpose



Nasal decongestant


Uses



temporarily relieves nasal congestion due to

  • common cold
  • hay fever or other respiratory allergies

Warnings



Do not exceed recommended dosage.


Stop Use And Ask A Doctor If



  • you get nervous, dizzy or sleepless
  • symptoms do not get better within 7 days or occur with fever

Ask A Doctor Before Use If You Have



  • diabetes
  • heart disease
  • high blood pressure
  • thyroid disease
  • trouble urinating due to an enlarged prostate gland

Otc - Do Not Use



Do not use if you are taking a prescription monoamine oxidase inhibitor (MAOI) (certain drugs for depression, psychiatric or emotional conditions, or Parkison'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.


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 enclosed dosage cup only. Do not use any other device.
  • adults & children 12 years & over2 teaspoonfuls
    children 6 to under 12 years1 teaspoonful
    children under 6 yearsdo not use

Other Information



  • store at 20°-25°C (68°-77°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?



1-800-645-2158


How Supplied



Product: 50090-0226

NDC: 50090-0226-0 118 mL in a BOTTLE


* Please review the disclaimer below.