PHENYLEPHRINE HCL MAXIMUM STRENGTH- phenylephrine hcl tablet, film coated 
Rugby Laboratories

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Rugby 44-453

Active ingredient (in each tablet)

Phenylephrine HCl 10 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 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

  • heart disease
  • diabetes
  • thyroid disease
  • high blood pressure
  • difficulty in urination due to enlargement of the prostate gland

When using this product

do not exceed recommended dosage.

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.

Directions

Other information

Inactive ingredients

croscarmellose sodium, dextrose monohydrate, dibasic calcium phosphate dihydrate, FD&C red #40, lecithin, magnesium stearate, maltodextrin, microcrystalline cellulose, silicon dioxide, sodium carboxymethylcellulose, sodium citrate dihydrate, titanium dioxide

Questions or comments?

1-800-645-2158

Principal display panel

Rugby®

NDC 0536-1291-36

Compare to the
active ingredient in
SUDAFED PE®
SINUS CONGESTION*

Maximum Strength
Phenylephrine HCl
10 mg

Nasal Decongestant

Sinus Pressure, Sinus and Nasal Congestion
Non-Drowsy

Actual Size

36 Tablets

TAMPER EVIDENT: DO NOT USE IF PACKAGE IS
OPENED OR IF BLISTER UNIT IS TORN, BROKEN
OR SHOWS ANY SIGNS OF TAMPERING

*This product is not manufactured or distributed by Johnson & Johnson
Corporation, owner of the registered trademark SUDAFED PE® SINUS
CONGESTION.    50844    REV0820A45307

Rev. 01/21   R-17   Re-order No. 371024

Distributed by: RUGBY® LABORATORIES
Livonia, MI 48152
www.rugbylaboratories.com

Rugby 44-453

Rugby 44-453

PHENYLEPHRINE HCL  MAXIMUM STRENGTH
phenylephrine hcl tablet, film coated
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:0536-1291
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
PHENYLEPHRINE HYDROCHLORIDE (UNII: 04JA59TNSJ) (PHENYLEPHRINE - UNII:1WS297W6MV) PHENYLEPHRINE HYDROCHLORIDE10 mg
Inactive Ingredients
Ingredient NameStrength
CROSCARMELLOSE SODIUM (UNII: M28OL1HH48)  
DEXTROSE MONOHYDRATE (UNII: LX22YL083G)  
DIBASIC CALCIUM PHOSPHATE DIHYDRATE (UNII: O7TSZ97GEP)  
FD&C RED NO. 40 (UNII: WZB9127XOA)  
LECITHIN, SOYBEAN (UNII: 1DI56QDM62)  
MAGNESIUM STEARATE (UNII: 70097M6I30)  
MALTODEXTRIN (UNII: 7CVR7L4A2D)  
MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U)  
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
CARBOXYMETHYLCELLULOSE SODIUM, UNSPECIFIED (UNII: K679OBS311)  
TRISODIUM CITRATE DIHYDRATE (UNII: B22547B95K)  
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
Product Characteristics
ColorredScoreno score
ShapeROUNDSize7mm
FlavorImprint Code 44;453
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:0536-1291-362 in 1 CARTON04/09/2020
118 in 1 BLISTER PACK; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC Monograph DrugM01204/09/2020
Labeler - Rugby Laboratories (079246066)
Establishment
NameAddressID/FEIBusiness Operations
LNK International, Inc.832867837manufacture(0536-1291) , pack(0536-1291)
Establishment
NameAddressID/FEIBusiness Operations
LNK International, Inc.832867894manufacture(0536-1291)
Establishment
NameAddressID/FEIBusiness Operations
LNK International, Inc.868734088manufacture(0536-1291)
Establishment
NameAddressID/FEIBusiness Operations
LNK International, Inc.117025878manufacture(0536-1291)

Revised: 2/2024
Document Id: a9a582ad-a504-47b7-a7d8-21a5593c2181
Set id: 953cad64-d587-4f25-a04f-fee2edf9ebb2
Version: 7
Effective Time: 20240222
 
Rugby Laboratories