RUGBY NASAL DECONGESTANT- pseudoephedrine hydrochloride liquid 
Rugby Laboratories, Inc.

Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

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Nasal Decongestant liquid

Drug Facts

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

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.

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.

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

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

PRINCIPAL DISPLAY PANEL - 118 mL Bottle Label

NDC 0536-1850-97

Rugby®

NASAL
DECONGESTANT
LIQUID

Pseudoephedrine HCl 30 mg

TEMPORARILY RELIEVES NASAL
CONGESTION DUE TO COLDS &
ALLERGIES WITHOUT DROWSINESS

4 fl oz
(118 mL)

Principal Display Panel - 118 mL Bottle Label
RUGBY  NASAL DECONGESTANT
pseudoephedrine hydrochloride liquid
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:0536-1850
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
PSEUDOEPHEDRINE HYDROCHLORIDE (UNII: 6V9V2RYJ8N) (PSEUDOEPHEDRINE - UNII:7CUC9DDI9F) PSEUDOEPHEDRINE HYDROCHLORIDE30 mg  in 5 mL
Inactive Ingredients
Ingredient NameStrength
SORBITOL (UNII: 506T60A25R)  
ANHYDROUS CITRIC ACID (UNII: XF417D3PSL)  
METHYLPARABEN (UNII: A2I8C7HI9T)  
FD&C RED NO. 40 (UNII: WZB9127XOA)  
GLYCERIN (UNII: PDC6A3C0OX)  
RASPBERRY (UNII: 4N14V5R27W)  
WATER (UNII: 059QF0KO0R)  
SODIUM BENZOATE (UNII: OJ245FE5EU)  
SACCHARIN SODIUM (UNII: SB8ZUX40TY)  
Product Characteristics
ColorredScore    
ShapeSize
FlavorRASPBERRYImprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:0536-1850-97118 mL in 1 BOTTLE; Type 0: Not a Combination Product07/26/199906/30/2020
2NDC:0536-1850-85473 mL in 1 BOTTLE; Type 0: Not a Combination Product07/26/199909/30/2020
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart34107/26/199909/30/2020
Labeler - Rugby Laboratories, Inc. (079246066)

Revised: 9/2019
Document Id: 936493a4-840d-59cc-e053-2a95a90ab836
Set id: f599f26c-d216-403c-acad-7065d395b694
Version: 4
Effective Time: 20190925
 
Rugby Laboratories, Inc.