NASAL DECONGESTANT PE- phenylephrine hydrochloride tablet, coated 
FRED'S, INC.

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.

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Freds 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

  • diabetes
  • heart disease
  • high blood pressure
  • thyroid disease
  • 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 (1-800-222-1222) right away.

Directions

Other information

Inactive ingredients

croscarmellose sodium, dextrose monohydrate, dicalcium phosphate dihydrate, FD&C red #40, lecithin, magnesiums 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    REV0313E45344

Fred's 44-453

Fred's 44-453

NASAL DECONGESTANT PE 
phenylephrine hcl tablet, coated
Product Information
Product TypeHUMAN OTC DRUG LABELItem 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 
CALCIUM PHOSPHATE, DIBASIC, DIHYDRATE 
FD&C RED NO. 40 
MAGNESIUM STEARATE 
MALTODEXTRIN 
CELLULOSE, MICROCRYSTALLINE 
SILICON DIOXIDE 
CARBOXYMETHYLCELLULOSE SODIUM 
TRISODIUM CITRATE DIHYDRATE 
TITANIUM DIOXIDE 
Product Characteristics
ColorREDScoreno score
ShapeROUNDSize6mm
FlavorImprint Code 44;453
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:55315-453-441 in 1 CARTON
118 in 1 BLISTER PACK
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC MONOGRAPH FINALpart34112/06/2004
Labeler - FRED'S, INC. (005866116)
Establishment
NameAddressID/FEIBusiness Operations
LNK International, Inc.038154464PACK(55315-453)
Establishment
NameAddressID/FEIBusiness Operations
LNK International, Inc.832867894MANUFACTURE(55315-453)

Revised: 12/2013
Document Id: 88f5c61e-2619-4a08-9c08-3dc9bd4b3e68
Set id: 490f7710-49c8-4bf5-a498-de058f026bb9
Version: 3
Effective Time: 20131231
 
FRED'S, INC.