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  5. Label Information: Rugby Nasal Decongestant Nasal Decongestant

FDA Label for Rugby Nasal Decongestant Nasal Decongestant

View Indications, Usage & Precautions

Table of Contents

    1. OTHER
    2. ACTIVE INGREDIENT (IN EACH TEASPOONFUL [TSP])
    3. PURPOSE
    4. USES
    5. OTC - DO NOT USE
    6. OTC - ASK DOCTOR
    7. WHEN USING THIS PRODUCT
    8. STOP USE AND ASK A DOCTOR IF
    9. OTC - PREGNANCY OR BREAST FEEDING
    10. OTC - KEEP OUT OF REACH OF CHILDREN
    11. DIRECTIONS
    12. OTHER INFORMATION
    13. INACTIVE INGREDIENTS
    14. QUESTIONS OR COMMENTS?
    15. PRINCIPAL DISPLAY PANEL

Rugby Nasal Decongestant Nasal Decongestant Product Label

The following document was submitted to the FDA by the labeler of this product Dispensing Solutions, Inc.. 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

Mfd. for:
Rugby Laboratories, Inc.
Duluth, Georgia 30097


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 over2 TSP
    children 6 to under 12 years1 TSP
    children under 6 yearsdo 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.