NASAL DECONGESTANT PE- phenylephrine hydrochloride tablet 
National Distribution Network (Smart Choice)

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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Drug Facts

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

  • high blood pressure
  • heart disease
  • thyroid disease
  • diabetes
  • 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 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.

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 for children under 12 years of age

Other information

  • store at 20º-25ºC (68º-77ºF)

Inactive ingredients

carnauba wax, croscarmellose sodium, dibasic calcium phosphate dihydrate, FD&C red #40 aluminium lake, FD&C yellow #6 aluminium lake, hypromellose, magnesium stearate, microcrystalline cellulose, polyethylene glycol (PEG) 400, stearic acid, titanium dioxide

Questions or comments?

Call 1-877-753-3935 Monday-Friday 9AM-5PM EST

Principal Display Panel

Compare to the active ingredient in SUDAFED PE®*

Non Drowsy

Maximum Strength

Nasal Decongestant PE

Phenylephrine HCl 10 mg

Nasal Decongestant

Pseudoephedrine free

Without Drowsiness

  • Nasal & Sinus Congestion
  • Sinus Pressure

TABLETS

1 pill dose

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

KEEP OUTER CARTON FOR COMPLETE WARNINGS AND PRODUCT INFORMATION.

DISTRIBUTED BY

NATIONAL DISTRIBUTION NETWORK

P.O BOX 875

MELVILLE, NY 11747-0875

Package Label

 Phenylephrine HCl 10 mg

Smart Choice Nasal Decongestant PE Tablets

NASAL DECONGESTANT PE 
phenylephrine hydrochloride tablet
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:53441-670
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
CARNAUBA WAX (UNII: R12CBM0EIZ)  
CROSCARMELLOSE SODIUM (UNII: M28OL1HH48)  
CALCIUM PHOSPHATE, DIBASIC, DIHYDRATE (UNII: O7TSZ97GEP)  
FD&C RED NO. 40 (UNII: WZB9127XOA)  
FD&C YELLOW NO. 6 (UNII: H77VEI93A8)  
HYPROMELLOSES (UNII: 3NXW29V3WO)  
MAGNESIUM STEARATE (UNII: 70097M6I30)  
CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)  
POLYETHYLENE GLYCOL 400 (UNII: B697894SGQ)  
STEARIC ACID (UNII: 4ELV7Z65AP)  
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
Product Characteristics
ColorREDScoreno score
ShapeROUNDSize7mm
FlavorImprint Code T234
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:53441-670-1818 in 1 CARTON06/30/201412/31/2018
11 in 1 BLISTER PACK; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC MONOGRAPH FINALpart34106/30/201412/31/2018
Labeler - National Distribution Network (Smart Choice) (045099210)

Revised: 12/2018
Document Id: 949715af-c5d9-4d8a-adc3-09462c4bc3fb
Set id: 4a146ce8-0ee3-4c30-9cef-320a633b51e2
Version: 2
Effective Time: 20181226
 
National Distribution Network (Smart Choice)