BERKLEY AND JENSEN NASAL DECONGESTANT PE NON-DROWSY MAXIMUM STRENGTH- phenylephrine hydrochloride tablet 
BJWC

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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BJWC Nasal Decongestant PE 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 use more than directed

Stop use and ask a doctor if

•
you get nervous, dizzy or sleepless
•
symptoms do not improve within 7 days or are accompanied by 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

do not use this product in children under 12 years of age

Other information

•
store at 20º-25ºC (68º-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?

1-800-934-1204

Principal Display Panel

Compare to the active ingredient in Sudafed PE® Congestion

NON-DROWSY

MAXIMUM STRENGTH

NASAL DECONGESTANT PE

PHENYLEPHRINE HCl TABLETS

GLUTEN FREE

NASAL DECONGESTANT

SINUS PRESSURE + CONGESTION

72 TABLETS

10 mg EACH

ACTUAL SIZE

1 PILL / DOSE

Berkley and Jensen Nasal Decongestant PE Image 1
Berkley and Jensen Nasal Decongestant PE Image 2
BERKLEY AND JENSEN NASAL DECONGESTANT PE  NON-DROWSY MAXIMUM STRENGTH
phenylephrine hydrochloride tablet
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:68391-094
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
ANHYDROUS DIBASIC CALCIUM PHOSPHATE (UNII: L11K75P92J)  
CARNAUBA WAX (UNII: R12CBM0EIZ)  
MAGNESIUM STEARATE (UNII: 70097M6I30)  
CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)  
POLYETHYLENE GLYCOLS (UNII: 3WJQ0SDW1A)  
POLYVINYL ALCOHOL (UNII: 532B59J990)  
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
TALC (UNII: 7SEV7J4R1U)  
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
Product Characteristics
ColorREDScoreno score
ShapeROUNDSize8mm
FlavorImprint Code L7
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:68391-094-781 in 1 CARTON06/05/200911/17/2017
1100 in 1 BOTTLE; Type 0: Not a Combination Product
2NDC:68391-094-233 in 1 CARTON06/05/200911/17/2017
218 in 1 BLISTER PACK; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart34106/05/200911/17/2017
Labeler - BJWC (159082692)

Revised: 11/2017
Document Id: f26d5e1b-17d8-4d97-93ba-c05f2d37bb50
Set id: 694f6626-a24f-481c-86e9-39b8af814b3f
Version: 5
Effective Time: 20171118
 
BJWC