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Nasal Decongestant PE by Better Living Brands, LLC

Medically reviewed on February 26, 2018

Dosage form: tablet, film coated
Ingredients: PHENYLEPHRINE HYDROCHLORIDE 10mg
Labeler: Better Living Brands, LLC
NDC Code: 21130-453

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.

Signature Care 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
  • diabetes
  • heart disease
  • high blood pressure
  • thyroid disease
  • 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: ask a doctor

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

Questions or comments?

1-800-426-9391

Principal Display Panel

NDC 21130-453-07

Signature
care
Quality Guaranteed

Maximum Strength
Nasal
Decongestant PE

PHENYLEPHRINE HCl 10 mg
Nasal Decongestant

Compare to
Sudafed PE® Congestion
active ingredient*

  • Non-drowsy
  • Relief of:
    Congestion &
    sinus pressure

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 McNeil Consumer Healthcare, distributors of Sudafed PE® Congestion. 
50844     REV0715J45307

DISTRIBUTED BY BETTER LIVING BRANDS LLC
P.O. BOX 99, PLEASANTON, CA 94566-0009
1-888-723-3929  www.betterlivingbrandsLLC.com

OUR PROMISE
QUALITY & SATISFACTION
100%
GUARANTEED

OR YOUR MONEY BACK.

Signature Care 44-453

NASAL DECONGESTANT PE 
phenylephrine hcl tablet, film coated
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:21130-453
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 
CELLULOSE, MICROCRYSTALLINE 
TITANIUM DIOXIDE 
SILICON DIOXIDE 
Product Characteristics
ColorREDScoreno score
ShapeROUNDSize7mm
FlavorImprint Code44;453
Contains    
Packaging
#Item CodePackage Description
1NDC:21130-453-071 BLISTER PACK in 1 CARTON
136 TABLET, FILM COATED in 1 BLISTER PACK
2NDC:21130-453-441 BLISTER PACK in 1 CARTON
218 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 - Better Living Brands, LLC (009137209)
Establishment
NameAddressID/FEIOperations
LNK International, Inc.832867894MANUFACTURE(21130-453)
Establishment
NameAddressID/FEIOperations
LNK International, Inc.038154464PACK(21130-453)
Establishment
NameAddressID/FEIOperations
LNK International, Inc.832867837PACK(21130-453)
Establishment
NameAddressID/FEIOperations
LNK International, Inc.967626305PACK(21130-453)
Establishment
NameAddressID/FEIOperations
LNK International, Inc.868734088PACK(21130-453)

 
Better Living Brands, LLC

← See all Nasal Decongestant PE brands

Further information

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

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