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Nasal Decongestant PE by FRED'S, INC.

Medically reviewed on August 30, 2017

Dosage form: tablet, film coated
Ingredients: PHENYLEPHRINE HYDROCHLORIDE 10mg
Labeler: FRED'S, INC.
NDC Code: 55315-453

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.

Freds 44-453

Active ingredient (in each tablet)

Phenylephrine HCl 10 mg

Purpose

Nasal decongestant

Uses
  • temporarily relieves nasal congestion due to the common cold, hay fever or other upper respiratory allergies
  • temporarily relieves sinus congestion and pressure

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 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 (1-800-222-1222) right away.

Directions
  • adults and children 12 years and over: take 1 tablet every 4 hours. Do not take more than 6 tablets in 24 hours.
  • children under 12 years: do not use this product in children under 12 years of age 

Other information
  • TAMPER EVIDENT: DO NOT USE IF OUTER PACKAGE IS OPENED OR BLISTER IS TORN OR BROKEN
  • store at 25ºC (77ºF); excursions permitted between 15º-30ºC (59º-86ºF)
  • see end flap for expiration date and lot number 

Inactive ingredients

croscarmellose sodium, dextrose monohydrate, dicalcium phosphate dihydrate, FD&C red #40, lecithin, magnesium stearate, maltodextrin, microcrystalline cellulose, silica gel, sodium carboxymethylcellulose, sodium citrate dihydrate, titanium dioxide

Principal display panel

fred's®

Maximum Strength
Nasal Decongestant PE

Phenylephrine HCl 10 mg | Nasal Decongestant 

Non-Drowsy
Sinus Pressure
Congestion

18 Tablets

Compare to the
active ingredient in:

Sudafed PE®
Congestion*

DISTRIBUTED BY: fred's, Inc.
4300 NEW GETWELL RD, MEMPHIS, TN 38118
www.fredsinc.com

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
McNeil Consumer Healthcare, owner of the registered
trademark Sudafed PE® Congestion.
50844    REV0715F45344

Freds 44-453

NASAL DECONGESTANT PE 
phenylephrine hcl tablet, film coated
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:55315-453
Route of AdministrationORALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
PHENYLEPHRINE HYDROCHLORIDE (PHENYLEPHRINE) PHENYLEPHRINE HYDROCHLORIDE10 mg
Inactive Ingredients
Ingredient NameStrength
CROSCARMELLOSE SODIUM 
DEXTROSE MONOHYDRATE 
FD&C RED NO. 40 
MAGNESIUM STEARATE 
MALTODEXTRIN 
MICROCRYSTALLINE CELLULOSE 
SILICON DIOXIDE 
TRISODIUM CITRATE DIHYDRATE 
TITANIUM DIOXIDE 
CARBOXYMETHYLCELLULOSE SODIUM, UNSPECIFIED FORM 
DIBASIC CALCIUM PHOSPHATE DIHYDRATE 
Product Characteristics
ColorREDScoreno score
ShapeROUNDSize7mm
FlavorImprint Code44;453
Contains    
Packaging
#Item CodePackage Description
1NDC:55315-453-441 BLISTER PACK in 1 CARTON
118 TABLET, FILM COATED in 1 BLISTER PACK
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC MONOGRAPH FINALpart34101/14/2005
Labeler - FRED'S, INC. (005866116)
Establishment
NameAddressID/FEIOperations
LNK International, Inc.038154464PACK(55315-453)
Establishment
NameAddressID/FEIOperations
LNK International, Inc.832867894MANUFACTURE(55315-453)
Establishment
NameAddressID/FEIOperations
LNK International, Inc.832867837PACK(55315-453)
Establishment
NameAddressID/FEIOperations
LNK International, Inc.868734088PACK(55315-453)
Establishment
NameAddressID/FEIOperations
LNK International, Inc.967626305PACK(55315-453)

 
FRED'S, INC.

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Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

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