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Nasal Decongestant by Rugby Laboratories, Inc

Medically reviewed on September 22, 2017

Dosage form: tablet, sugar coated
Ingredients: PSEUDOEPHEDRINE HYDROCHLORIDE 30mg
Labeler: Rugby Laboratories, Inc
NDC Code: 0536-4391

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.

DRUG FACTS

Active ingredient (in each tablet)
Pseudoephedrine HCl 30 mg

Purpose
Nasal Decongestant

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 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.

Ask a doctor before use if you have
  • high blood pressure
  • heart disease
  • 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
  • you get nervous, dizzy or sleepless
  • symptoms do not improve within 7 days or accompanied by 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
adults and children 12 years and over: 2 tablets
children 6 to under 12 years: 1 tablet
children under 6 years: do not use

Other information
  • store at 25°C (77°F), excursions permitted between 15°-30°C (59°-86°F)
  • protect from light

Inactive ingredients acacia, calcium sulfate anhydrous, carnauba wax, colloidal silicon dioxide, corn starch, D-C red #27 aluminum lake, D-C yellow #10 aluminum lake, FD-C red #40 aluminum lake, FD-C yellow #6 aluminum lake, iron oxide black, iron oxide red, iron oxide yellow (iron oxide ochre), kaolin, microcrystalline cellulose, polyethylene glycol (PEG) - 400, pregelatinized starch, shellac, sodium starch glycolate, stearic acid, sugar, talc, titanium dioxide

Questions or comments? call 1-800-645-2158, 9 am - 5 pm ET, Monday - Friday


NASAL DECONGESTANT 
pseudoephedrine hcl tablet, sugar coated
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:0536-4391
Route of AdministrationORALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
PSEUDOEPHEDRINE HYDROCHLORIDE (PSEUDOEPHEDRINE) PSEUDOEPHEDRINE HYDROCHLORIDE30 mg
Inactive Ingredients
Ingredient NameStrength
ACACIA 
CALCIUM SULFATE ANHYDROUS 
CARNAUBA WAX 
SILICON DIOXIDE 
STARCH, CORN 
D&C RED NO. 27 
D&C YELLOW NO. 10 
FD&C RED NO. 40 
FD&C YELLOW NO. 6 
FERROSOFERRIC OXIDE 
FERRIC OXIDE RED 
FERRIC OXIDE YELLOW 
KAOLIN 
CELLULOSE, MICROCRYSTALLINE 
POLYETHYLENE GLYCOL 400 
STARCH, CORN 
SHELLAC 
SODIUM STARCH GLYCOLATE TYPE A POTATO 
STEARIC ACID 
SUCROSE 
TALC 
TITANIUM DIOXIDE 
Product Characteristics
ColorredScoreno score
ShapeROUNDSize7mm
FlavorImprint CodeTCL;016
Contains    
Packaging
#Item CodePackage Description
1NDC:0536-4391-3524 TABLET, SUGAR COATED (TABLET) in 1 BLISTER PACK
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart34109/22/2011
Labeler - Rugby Laboratories, Inc (109178264)
Registrant - Time Cap Labs, Inc (037052099)
Establishment
NameAddressID/FEIOperations
Time Cap Labs, Inc037052099manufacture

 
Rugby Laboratories, Inc

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Further information

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

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