NASAL DECONGESTANT- pseudoephedrine hcl tablet 
Rugby Laboratories

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1004 - Rugby

Drug Facts

Active ingredient (in each tablet)

Pseudoephedrine HCl 30 mg

Purpose

Nasal decongestant

Uses

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 exceed recommended dose

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

Inactive ingredients

calcium sulfate, carnauba wax, corn starch, croscarmellose sodium, FD&C red #40 lake, FD&C yellow #6 lake, gelatin, kaolin, lactose monohydrate, magnesium stearate, microcrystalline cellulose, shellac, silicon dioxide, stearic acid, sucrose, talc, titanium dioxide.

Questions or comments?

1-800-616-2471

*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

Indianapolis, IN 46268

www.majorpharmaceuticals.com

Re-order No. 370277

Rev. 08/22 R-29

Rugby®

Compare to active ingredient in Sudafed® Sinus Congestion*

NDC 0536-3607-35

Nasal Decongestant

Pseudoephedrine HCl 30 mg

Temporarily relieves nasal congestion due to colds & allergies without drowsiness

24 tablets

Rugby Label

NASAL DECONGESTANT 
pseudoephedrine hcl tablet
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:0536-3607
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
PSEUDOEPHEDRINE HYDROCHLORIDE (UNII: 6V9V2RYJ8N) (PSEUDOEPHEDRINE - UNII:7CUC9DDI9F) PSEUDOEPHEDRINE HYDROCHLORIDE30 mg
Inactive Ingredients
Ingredient NameStrength
CROSCARMELLOSE SODIUM (UNII: M28OL1HH48)  
FD&C YELLOW NO. 6 (UNII: H77VEI93A8)  
MAGNESIUM STEARATE (UNII: 70097M6I30)  
CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)  
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
CALCIUM SULFATE ANHYDROUS (UNII: E934B3V59H)  
CARNAUBA WAX (UNII: R12CBM0EIZ)  
FD&C RED NO. 40 (UNII: WZB9127XOA)  
GELATIN (UNII: 2G86QN327L)  
KAOLIN (UNII: 24H4NWX5CO)  
LACTOSE MONOHYDRATE (UNII: EWQ57Q8I5X)  
TALC (UNII: 7SEV7J4R1U)  
SHELLAC (UNII: 46N107B71O)  
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
STEARIC ACID (UNII: 4ELV7Z65AP)  
SUCROSE (UNII: C151H8M554)  
STARCH, CORN (UNII: O8232NY3SJ)  
Product Characteristics
ColorredScoreno score
ShapeROUNDSize8mm
FlavorImprint Code 1004
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:0536-3607-351 in 1 CARTON10/29/2012
124 in 1 BLISTER PACK; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC Monograph DrugM01210/29/2012
Labeler - Rugby Laboratories (079246066)

Revised: 1/2024
Document Id: 0eafac67-d7aa-5b86-e063-6394a90a2184
Set id: 775f97c0-6f82-49a8-82ac-f1a73920c3ec
Version: 5
Effective Time: 20240111
 
Rugby Laboratories