TOPCARE NASAL DECONGESTANT PE- phenylephrine hydrochloride tablet, film coated 
Topco Associates 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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Topco Associates LLC. Nasal Decongestant PE Drug Facts

Active ingredient (in each tablet)

Phenylephrine HCl 10 mg

Purpose

Nasal decongestant

Uses

temporarily relieves sinus congestion and pressure
temporarily relieves nasal congestion due to the common cold, hay fever or other upper respiratory allergies

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 dosage

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 (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

ask a doctor

Other information

store at 20-25°C (68-77°F)
do not use if blister unit is broken or torn

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?

1-888-423-0139

Principal Display Panel

COMPARE TO SUDAFED PE® CONGESTION

ACTIVE INGREDIENT

NON-DROWSY

Nasal Decongestant PE

PHENYLEPHRINE HCl TABLETS, 10 mg

MAXIMUM STRENGTH

OUR PHARMACISTS RECOMMEND

Sinus + Nasal Congestion

Sinus Pressure

actual size

72 TABLETS

nasal decongestant pe image
TOPCARE NASAL DECONGESTANT PE 
phenylephrine hydrochloride tablet, film coated
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:36800-094
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)  
MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U)  
POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A)  
POLYVINYL ALCOHOL, UNSPECIFIED (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:36800-094-2312 in 1 CARTON09/19/200501/31/2022
16 in 1 BLISTER PACK; Type 0: Not a Combination Product
2NDC:36800-094-471 in 1 CARTON02/03/200907/02/2011
2150 in 1 BOTTLE; Type 0: Not a Combination Product
3NDC:36800-094-686 in 1 CARTON09/13/2005
36 in 1 BLISTER PACK; Type 0: Not a Combination Product
4NDC:36800-094-893 in 1 CARTON09/12/2005
46 in 1 BLISTER PACK; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart34109/12/2005
Labeler - Topco Associates LLC (006935977)

Revised: 11/2021
Document Id: 2886e45d-ddcc-4f3b-ae88-26d7e5c528f8
Set id: 1a903229-a8c5-40ff-86af-737e77c8feec
Version: 5
Effective Time: 20211116
 
Topco Associates LLC