DG HEALTH NASAL DECONGESTANT PE MAXIMUM STRENGTH- phenylephrine hydrochloride tablet 
Dolgencorp, LLC

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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Dolgencorp, LLC 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
trouble urinating due to an enlarged prostate gland
diabetes

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? 1-888-309-9030

Principal Display Panel

Compare to active ingredient of Sudafed PE®

Maximum Strength

Nasal Decongestant PE

Phenylephrine HCl Tablets, 10 mg

Non-Drowsy

Nasal & Sinus Congestion

Sinus Pressure

1 Pill/Dose

SEE NEW DOSING DIRECTIONS

Nasal Decongestant PE Carton Image 1

Nasal Decongestant PE Carton Image 1

Nasal Decongestant PE Carton Image 2

Nasal Decongestant PE Carton Image 1

Nasal Decongestant PE Carton Image 2

DG HEALTH NASAL DECONGESTANT PE  MAXIMUM STRENGTH
phenylephrine hydrochloride tablet
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:55910-094
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
CARNAUBA WAX (UNII: R12CBM0EIZ)  
ANHYDROUS DIBASIC CALCIUM PHOSPHATE (UNII: L11K75P92J)  
MAGNESIUM STEARATE (UNII: 70097M6I30)  
CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)  
POLYETHYLENE GLYCOL (UNII: 3WJQ0SDW1A)  
POLYVINYL ALCOHOL (UNII: 532B59J990)  
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
TALC (UNII: 7SEV7J4R1U)  
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
FD&C RED NO. 40 (UNII: WZB9127XOA)  
Product Characteristics
ColorREDScoreno score
ShapeROUNDSize8mm
FlavorImprint Code L7
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:55910-094-682 in 1 CARTON02/26/2010
118 in 1 BLISTER PACK; Type 0: Not a Combination Product
2NDC:55910-094-891 in 1 CARTON01/29/2010
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 finalpart34101/29/2010
Labeler - Dolgencorp, LLC (068331990)

Revised: 12/2018
Document Id: db87d659-4b69-4a77-b080-11880b9c7da8
Set id: 3deabbf5-fe4f-4659-859b-3bb1a4ab70dd
Version: 2
Effective Time: 20181219
 
Dolgencorp, LLC