RUGBY  NASAL DECONGESTANT- pseudoephedrine hydrochloride liquid 
A-S Medication Solutions

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

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

adults & children 12 years & over2 teaspoonfuls
children 6 to under 12 years1 teaspoonful
children under 6 yearsdo not use

Other information

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

HOW SUPPLIED

Product: 50090-0226

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

Pseudoephedrine Hydrochloride

Label Image
RUGBY   NASAL DECONGESTANT
pseudoephedrine hydrochloride liquid
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:50090-0226(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:50090-0226-0118 mL in 1 BOTTLE; Type 0: Not a Combination Product11/28/2014
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC MONOGRAPH FINALpart34107/26/1999
Labeler - A-S Medication Solutions (830016429)
Establishment
NameAddressID/FEIBusiness Operations
A-S Medication Solutions830016429RELABEL(50090-0226)

Revised: 12/2017
Document Id: ee32a7e8-6697-405a-bf16-dcbc9379922c
Set id: 403f5679-f1ad-4e84-962d-3ad1964960b1
Version: 10
Effective Time: 20171221
 
A-S Medication Solutions