RUGBY  NASAL DECONGESTANT- pseudoephedrine hydrochloride liquid 
Bryant Ranch Prepack

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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Rugby ®
NASAL
DECONGESTANT
LIQUID

Drug Facts

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

Warnings

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.

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

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 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

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

HOW SUPPLIED

Product: 63629-3961

Pseudoephedrine 30mg/5ml Syrup

Label Image
RUGBY   NASAL DECONGESTANT
pseudoephedrine hydrochloride liquid
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:63629-3961(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)  
Citric Acid Monohydrate (UNII: 2968PHW8QP)  
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:63629-3961-1120 mL in 1 BOTTLE; Type 0: Not a Combination Product08/09/200611/01/2011
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC MONOGRAPH FINALpart34107/26/199911/01/2011
Labeler - Bryant Ranch Prepack (171714327)
Establishment
NameAddressID/FEIBusiness Operations
Bryant Ranch Prepack171714327REPACK(63629-3961) , RELABEL(63629-3961)

Revised: 8/2021
Document Id: 2aa3dcb6-2e60-437d-8ef3-3c3a2ae640dc
Set id: b3c652d6-5141-43f4-a1ac-889cb8b75ed1
Version: 1002
Effective Time: 20210817
 
Bryant Ranch Prepack