Berkley and Jensen Nasal Decongestant PE Non-Drowsy Maximum Strength

Dosage form: tablet
Ingredients: PHENYLEPHRINE HYDROCHLORIDE 10mg
Labeler: BJWC
NDC Code: 68391-094

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.

BJWC Nasal Decongestant PE Drug Facts

Active ingredient (in each tablet)

Phenylephrine hydrochloride 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

DECONGESTANT

NON DROWSY – MAXIMUM STRENGTH

NASAL DECONGESTANT PE

PHENYLEPHRINE HCl TABLETS – NASAL DECONGESTANT

NASAL & SINUS CONGESTION – SINUS PRESSURE

Compare to the active ingredient of Non-Drowsy Sudafed PE® Maximum Strength Nasal Decongestant Tablets

72 TABLETS

10 mg EACH

1 PILL/DOSE

GLUTEN GREE

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 AdministrationORALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
PHENYLEPHRINE HYDROCHLORIDE (PHENYLEPHRINE) PHENYLEPHRINE HYDROCHLORIDE10 mg
Inactive Ingredients
Ingredient NameStrength
CALCIUM PHOSPHATE, DIBASIC, ANHYDROUS 
CARNAUBA WAX 
MAGNESIUM STEARATE 
CELLULOSE, MICROCRYSTALLINE 
POLYETHYLENE GLYCOLS 
POLYVINYL ALCOHOL 
SILICON DIOXIDE 
TALC 
TITANIUM DIOXIDE 
Product Characteristics
ColorREDScoreno score
ShapeROUNDSize8mm
FlavorImprint CodeL7
Contains    
Packaging
#Item CodePackage Description
1NDC:68391-094-781 BOTTLE in 1 CARTON
1100 TABLET in 1 BOTTLE
2NDC:68391-094-234 BLISTER PACK in 1 CARTON
218 TABLET in 1 BLISTER PACK
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart34106/05/2009
Labeler - BJWC (159082692)

Revised: 11/2013
 
BJWC

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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