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Nasal Decongestant by Premier Value (Chain Drug Consortium, LLC)

Dosage form: tablet
Ingredients: PHENYLEPHRINE HYDROCHLORIDE 10mg
Labeler: Premier Value (Chain Drug Consortium, LLC)
NDC Code: 68016-235

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.

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
  • heart disease
  • high blood pressure
  • 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®

MAXIMUM STRENGTH

Nasal Decongestant PE

NON-DROWSY

PHENYLEPHRINE HCl 10 mg

Relief of:

  • Sinus Pressure
  • Congestion

Tablets

*This product is not manufactured or distributed by McNeil Consumer Healthcare, owner of the registered trademark Sudafed PE®.

DISTRIBUTED BY: CHAIN DRUG CONSORTIUM, LLC

3301 NW BOCA RATON BLVD. SUITE 101

BOCA RATON, FL 33431

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.

Product Label

Premier Value Nasal Decongestant PE Tablet

NASAL DECONGESTANT 
phenylephrine hcl tablet
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:68016-235
Route of AdministrationORALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
PHENYLEPHRINE HYDROCHLORIDE (PHENYLEPHRINE) PHENYLEPHRINE HYDROCHLORIDE10 mg
Inactive Ingredients
Ingredient NameStrength
CARNAUBA WAX 
CROSCARMELLOSE SODIUM 
CALCIUM PHOSPHATE, DIBASIC, DIHYDRATE 
FD&C RED NO. 40 
FD&C YELLOW NO. 6 
HYPROMELLOSES 
MAGNESIUM STEARATE 
CELLULOSE, MICROCRYSTALLINE 
POLYETHYLENE GLYCOL 400 
STEARIC ACID 
TITANIUM DIOXIDE 
Product Characteristics
ColorREDScoreno score
ShapeROUNDSize7mm
FlavorImprint CodeT234
Contains    
Packaging
#Item CodePackage Description
1NDC:68016-235-1818 BLISTER PACK (18 BLISTER PACK) in 1 CARTON
11 TABLET (1 TABLET) in 1 BLISTER PACK
2NDC:68016-235-3636 BLISTER PACK (36 BLISTER PACK) in 1 CARTON
21 TABLET (1 TABLET) in 1 BLISTER PACK
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC MONOGRAPH FINALpart34107/12/2010
Labeler - Premier Value (Chain Drug Consortium, LLC) (101668460)

Revised: 03/2014
 
Premier Value (Chain Drug Consortium, LLC)

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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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