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NDC 36800-0054-52 topcare 12 hour decongestant 120 mg/1 Details

topcare 12 hour decongestant 120 mg/1

topcare 12 hour decongestant is a ORAL TABLET, FILM COATED, EXTENDED RELEASE in the HUMAN OTC DRUG category. It is labeled and distributed by Topco Associates LLC. The primary component is PSEUDOEPHEDRINE HYDROCHLORIDE.

MedlinePlus Drug Summary

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

Related Packages: 36800-0054-52
Last Updated: 11/30/2022
MedLinePlus Full Drug Details: Pseudoephedrine

Product Information

NDC	36800-0054
Product ID	36800-054_1dc8f02b-e7c0-4a83-b9f4-49d7384a7ba6
Associated GPIs	42101020107405
GCN Sequence Number	016937
GCN Sequence Number Description	pseudoephedrine HCl TABLET ER 120 MG ORAL
HIC3	B6V
HIC3 Description	DECONGESTANTS, ORAL
GCN	26901
HICL Sequence Number	002091
HICL Sequence Number Description	PSEUDOEPHEDRINE HCL
Brand/Generic	Generic
Proprietary Name	topcare 12 hour decongestant
Proprietary Name Suffix	n/a
Non-Proprietary Name	Pseudoephedrine Hydrochloride
Product Type	HUMAN OTC DRUG
Dosage Form	TABLET, FILM COATED, EXTENDED RELEASE
Route	ORAL
Active Ingredient Strength	120
Active Ingredient Units	mg/1
Substance Name	PSEUDOEPHEDRINE HYDROCHLORIDE
Labeler Name	Topco Associates LLC
Pharmaceutical Class	Adrenergic alpha-Agonists [MoA], alpha-Adrenergic Agonist [EPC]
DEA Schedule	n/a
Marketing Category	ANDA
Application Number	ANDA075153
Listing Certified Through	2024-12-31

Package

Package Images

NDC 36800-0054-52 (36800005452)

Pricing Information	N/A
NDC Package Code	36800-054-52
Billing NDC	36800005452
Package	10 BLISTER PACK in 1 CARTON (36800-054-52) / 1 TABLET, FILM COATED, EXTENDED RELEASE in 1 BLISTER PACK
Marketing Start Date	2000-04-25
NDC Exclude Flag	N

Standard Product Labeling (SPL)/Prescribing Information SPL 4841c79a-fb92-4209-929a-e4ea0c4015dd Details

Active ingredient (in each tablet)

Pseudoephedrine HCl 120 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 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 12 hours • do not take more than 2 tablets in 24 hours
children under 12 years	do not use this product in children under 12 years of age

Other information

•: each tablet contains: calcium 45 mg
•: store at 20-25°C (68-77°F) in a dry place
•: protect from light
•: do not use if blister unit is broken or torn
•: see carton end panel for lot number and expiration date
•: this product meets the requirements of USP Drug Release Test 3

Inactive ingredients

carnauba wax, colloidal silicon dioxide, dibasic calcium phosphate dihydrate, hypromellose, magnesium stearate, microcrystalline cellulose, polyethylene glycol, polysorbate 80, titanium dioxide

Questions or comments?

1-888-423-0139

Principal Display Panel

TopCare® health

COMPARE TO SUDAFED® SINUS CONGESTION 12 HOUR ACTIVE INGREDIENT

NON-DROWSY

12 Hour Decongestant

PSEUDOEPHEDRINE HYDROCHLORIDE EXTENDED RELEASE TABLETS, 120 mg

NASAL DECONGESTANT

MAXIMUM STRENGTH • SINUS

12 HOUR

• Sinus Pressure + Congestion

20 COATED CAPLETS*

*CAPSULE-SHAPED TABLETS

actual size

INGREDIENTS AND APPEARANCE

TOPCARE 12 HOUR DECONGESTANT

pseudoephedrine hydrochloride tablet, film coated, extended release

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:36800-054
Route of Administration	ORAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
PSEUDOEPHEDRINE HYDROCHLORIDE (UNII: 6V9V2RYJ8N) (PSEUDOEPHEDRINE - UNII:7CUC9DDI9F)	PSEUDOEPHEDRINE HYDROCHLORIDE	120 mg

Ingredient Name	Strength
Inactive Ingredients
CARNAUBA WAX (UNII: R12CBM0EIZ)
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
DIBASIC CALCIUM PHOSPHATE DIHYDRATE (UNII: O7TSZ97GEP)
HYPROMELLOSE, UNSPECIFIED (UNII: 3NXW29V3WO)
MAGNESIUM STEARATE (UNII: 70097M6I30)
MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U)
POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A)
POLYSORBATE 80 (UNII: 6OZP39ZG8H)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)

Product Characteristics
Color	WHITE	Score	no score
Shape	OVAL	Size	18mm
Flavor		Imprint Code	L054
Contains

#	Item Code	Package Description	Marketing Start Date
Packaging
1	NDC:36800-054-52	10 in 1 CARTON	04/25/2000
1		1 in 1 BLISTER PACK; Type 0: Not a Combination Product
2	NDC:36800-054-60	20 in 1 CARTON	05/20/2003
2		1 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
ANDA	ANDA075153	04/25/2000

Labeler - Topco Associates LLC (006935977)

Revised: 10/2022

Document Id: 1dc8f02b-e7c0-4a83-b9f4-49d7384a7ba6

Set id: 4841c79a-fb92-4209-929a-e4ea0c4015dd

Version: 7

Effective Time: 20221005