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NASAL DECONGESTANT PE by International Laboratories, LLC

Dosage form: tablet
Ingredients: PHENYLEPHRINE HYDROCHLORIDE 10mg
Labeler: International Laboratories, LLC
NDC Code: 54458-847

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.

International Laboratories, Inc. Nasal Decongestant PE Drug Facts

Active ingredient (in each tablet)

 Phenylephrine HCl 10 mg

Purpose

Nasal decongestant

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

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
  • high blood pressure
  • thyroid disease
  • diabetes
  • trouble urinating due to an enlarged 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 a 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 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
  • store at 20-25ºC (68-77ºF)

Inactive ingredients

anhydrous dibasic calcium phosphate, carnauba wax, FD&C red no. 40 aluminum lake, lecithin, magnesium stearate, microcrystalline cellulose, polyethylene glycol, polyvinyl alcohol, silicon dioxide, talc, titanium dioxide

Questions or comments?

 1-800-579-1868

PRINCIPAL DISPLAY PANEL

Drug Facts Label

 

Drug Facts

PRINCIPAL DISPLAY PANEL

Compare to the active ingredient in Sudafed PE® Congestion

Non-Drowsy

Nasal Decongestant PE

PHENYLEPHRINE HYDROCHLORIDE TABLETS

10 mg - Nasal decongestant

DOES NOT CONTAIN PSEUDOEPHEDRINE

Relieves:

  • Nasal & sinus congestion
  • Sinus pressure

14 TABLETS

Actual Size

LIFT HERE TO OPEN

Nasal Decongestant PE

 

NASAL DECONGESTANT PE 
phenylephrine hydrochloride tablet
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:54458-847(NDC:59779-094)
Route of AdministrationORALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
PHENYLEPHRINE HYDROCHLORIDE (PHENYLEPHRINE) PHENYLEPHRINE HYDROCHLORIDE10 mg
Inactive Ingredients
Ingredient NameStrength
CARNAUBA WAX 
CALCIUM PHOSPHATE, DIBASIC, ANHYDROUS 
MAGNESIUM STEARATE 
CELLULOSE, MICROCRYSTALLINE 
POLYETHYLENE GLYCOLS 
POLYVINYL ALCOHOL, UNSPECIFIED 
SILICON DIOXIDE 
TALC 
TITANIUM DIOXIDE 
FD&C RED NO. 40 
LECITHIN, SOYBEAN 
Product Characteristics
ColorREDScoreno score
ShapeROUNDSize8mm
FlavorImprint CodeL7
Contains    
Packaging
#Item CodePackage Description
1NDC:54458-847-1414 TABLET in 1 BLISTER PACK
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC MONOGRAPH FINALpart34105/27/2016
Labeler - International Laboratories, LLC (023569924)
Establishment
NameAddressID/FEIOperations
International Laboratories, LLC023569924RELABEL(54458-847), REPACK(54458-847)
Establishment
NameAddressID/FEIOperations
L. Perrigo Company006013346MANUFACTURE(54458-847), RELABEL(54458-847), REPACK(54458-847)

Revised: 04/2017
 
International Laboratories, LLC

← See all NASAL DECONGESTANT PE brands

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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