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NDC 36800-0094-89 TopCare Nasal Decongestant PE 10 mg/1 Details

TopCare Nasal Decongestant PE 10 mg/1

TopCare Nasal Decongestant PE is a ORAL TABLET, FILM COATED in the HUMAN OTC DRUG category. It is labeled and distributed by Topco Associates LLC. The primary component is PHENYLEPHRINE HYDROCHLORIDE.

MedlinePlus Drug Summary

Phenylephrine is used to relieve nasal discomfort caused by colds, allergies, and hay fever. It is also used to relieve sinus congestion and pressure. Phenylephrine will relieve symptoms but will not treat the cause of the symptoms or speed recovery. Phenylephrine is in a class of medications called nasal decongestants. It works by reducing swelling of the blood vessels in the nasal passages.

Related Packages: 36800-0094-89
Last Updated: 11/30/2022
MedLinePlus Full Drug Details: Phenylephrine

Product Information

NDC	36800-0094
Product ID	36800-094_2886e45d-ddcc-4f3b-ae88-26d7e5c528f8
Associated GPIs	42101040100310
GCN Sequence Number	058496
GCN Sequence Number Description	phenylephrine HCl TABLET 10 MG ORAL
HIC3	B6V
HIC3 Description	DECONGESTANTS, ORAL
GCN	23944
HICL Sequence Number	002087
HICL Sequence Number Description	PHENYLEPHRINE HCL
Brand/Generic	Generic
Proprietary Name	TopCare Nasal Decongestant PE
Proprietary Name Suffix	n/a
Non-Proprietary Name	Phenylephrine Hydrochloride
Product Type	HUMAN OTC DRUG
Dosage Form	TABLET, FILM COATED
Route	ORAL
Active Ingredient Strength	10
Active Ingredient Units	mg/1
Substance Name	PHENYLEPHRINE HYDROCHLORIDE
Labeler Name	Topco Associates LLC
Pharmaceutical Class	Adrenergic alpha1-Agonists [MoA], alpha-1 Adrenergic Agonist [EPC]
DEA Schedule	n/a
Marketing Category	OTC MONOGRAPH FINAL
Application Number	part341
Listing Certified Through	2024-12-31

Package

Package Images

NDC 36800-0094-89 (36800009489)

Pricing Information	N/A
NDC Package Code	36800-094-89
Billing NDC	36800009489
Package	3 BLISTER PACK in 1 CARTON (36800-094-89) / 6 TABLET, FILM COATED in 1 BLISTER PACK
Marketing Start Date	2005-09-12
NDC Exclude Flag	N

Standard Product Labeling (SPL)/Prescribing Information SPL 1a903229-a8c5-40ff-86af-737e77c8feec Details

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

INGREDIENTS AND APPEARANCE

TOPCARE NASAL DECONGESTANT PE

phenylephrine hydrochloride tablet, film coated

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:36800-094
Route of Administration	ORAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
PHENYLEPHRINE HYDROCHLORIDE (UNII: 04JA59TNSJ) (PHENYLEPHRINE - UNII:1WS297W6MV)	PHENYLEPHRINE HYDROCHLORIDE	10 mg

Ingredient Name	Strength
Inactive Ingredients
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
Color	RED	Score	no score
Shape	ROUND	Size	8mm
Flavor		Imprint Code	L7
Contains

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:36800-094-23	12 in 1 CARTON	09/19/2005	01/31/2022
1		6 in 1 BLISTER PACK; Type 0: Not a Combination Product
2	NDC:36800-094-47	1 in 1 CARTON	02/03/2009	07/02/2011
2		150 in 1 BOTTLE; Type 0: Not a Combination Product
3	NDC:36800-094-68	6 in 1 CARTON	09/13/2005
3		6 in 1 BLISTER PACK; Type 0: Not a Combination Product
4	NDC:36800-094-89	3 in 1 CARTON	09/12/2005
4		6 in 1 BLISTER PACK; Type 0: Not a Combination Product

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph final	part341	09/12/2005

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