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Nasal Decongestant by Rugby Laboratories

Dosage form: tablet
Ingredients: PSEUDOEPHEDRINE HYDROCHLORIDE 30mg
Labeler: Rugby Laboratories
NDC Code: 0536-3607

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.

1004 - Rugby

Drug Facts

Pseudoephedrine Hydrochloride 30 mg

Purpose

Nasal Congestant

Uses
  • temporarily relieves nasal congestion due to the common cold, hay fever or other upper respiratory allergies
  • temporarily restores freer breathing through the nose

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 2 weeks after stopping the MAOI drug. If you do not know if your prescription drug contains and MAOI, ask a doctor or pharmacist before taking this product.

Ask a doctor before use if you have
  • heart disease
  • high blood pressure
  • thyroid disease
  • diabetes
  • 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
  • nervousness, dizziness, or sleeplessness occur
  • 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 (1-800-222-1222).

Directions
adults and children 12 years and oldertake 2 tablets every 4 to 6 hours; do not take more than 8 tablets in 24 hours
children ages 6 to 12 yearstake 1 tablet every 4 to 6 hours; do not take more than 4 tablets in 24 hours
children under 6 yearsdo not use

Other information
  • store at room temperature

Inactive ingredients

Calcium sulfate, carnauba wax, croscarmellose sodium, FD&C red #40 lake, FD&C yellow #6 lake, gelatin, kaolin, lactose, magnesium silicate, magnesium stearate, microcrystalline cellulose, pharmaceutical glaze, silica, stearic acid, sugar and titanium dioxide

Questions or comments?

1-800-645-2158

*Rugby Laboratories is not affiliated with the owner of the registered trademark Sudafed®

SAFETY SEALED: DO NOT USE IF BLISTER SEAL IS BROKEN

Distributed by:

Rugby Laboratories

17177 N Laurel Park Drive, Suite 233

Livonia, MI 48152

www.rugbylaboratories.com

Re-order No. 370277

Rev. 03/17 R-29

Rugby®

Compare to active ingredient in Sudafed®

NDC 0536-3607-35

Nasal Decongestant

Pseudoephedrine HCl 30 mg

Temporarily relieves nasal congestion due to cold & allergies without drowsiness

24 tablets

NASAL DECONGESTANT 
pseudoephedrine hcl tablet
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:0536-3607
Route of AdministrationORALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
PSEUDOEPHEDRINE HYDROCHLORIDE (PSEUDOEPHEDRINE) PSEUDOEPHEDRINE HYDROCHLORIDE30 mg
Inactive Ingredients
Ingredient NameStrength
CROSCARMELLOSE SODIUM 
FD&C YELLOW NO. 6 
MAGNESIUM STEARATE 
CELLULOSE, MICROCRYSTALLINE 
TITANIUM DIOXIDE 
CALCIUM SULFATE ANHYDROUS (CALCIUM CATION)  
CARNAUBA WAX 
FD&C RED NO. 40 
GELATIN 
KAOLIN 
LACTOSE MONOHYDRATE (ANHYDROUS LACTOSE)  
MAGNESIUM SILICATE 
SHELLAC 
SILICON DIOXIDE 
STEARIC ACID 
SUCROSE 
Product Characteristics
ColorredScoreno score
ShapeROUNDSize8mm
FlavorImprint Code1004
Contains    
Packaging
#Item CodePackage Description
1NDC:0536-3607-351 BLISTER PACK in 1 CARTON
124 TABLET in 1 BLISTER PACK
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart34110/29/2012
Labeler - Rugby Laboratories (079246066)

 
Rugby Laboratories

← See all Nasal Decongestant brands

Medically reviewed on Dec 21, 2017

Further information

Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.

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