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NDC 36800-0432-67 Topcare Nasal Decongestant 30 mg/1 Details

Topcare Nasal Decongestant 30 mg/1

Topcare Nasal Decongestant 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 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: 36800-0432-67
Last Updated: 11/30/2022
MedLinePlus Full Drug Details: Pseudoephedrine

Product Information

NDC	36800-0432
Product ID	36800-432_4b199c18-a168-4aab-b4b6-b2bd16fa6488
Associated GPIs	42101020100305
GCN Sequence Number	005089
GCN Sequence Number Description	pseudoephedrine HCl TABLET 30 MG ORAL
HIC3	B6V
HIC3 Description	DECONGESTANTS, ORAL
GCN	20481
HICL Sequence Number	002091
HICL Sequence Number Description	PSEUDOEPHEDRINE HCL
Brand/Generic	Generic
Proprietary Name	Topcare Nasal Decongestant
Proprietary Name Suffix	Maximum Strength Non Drowsy
Non-Proprietary Name	Pseudoephedrine HCl
Product Type	HUMAN OTC DRUG
Dosage Form	TABLET, FILM COATED
Route	ORAL
Active Ingredient Strength	30
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	OTC MONOGRAPH FINAL
Application Number	part341
Listing Certified Through	2024-12-31

Package

Package Images

NDC 36800-0432-67 (36800043267)

Pricing Information	N/A
NDC Package Code	36800-432-67
Billing NDC	36800043267
Package	48 BLISTER PACK in 1 CARTON (36800-432-67) / 1 TABLET, FILM COATED in 1 BLISTER PACK
Marketing Start Date	1990-02-15
NDC Exclude Flag	N

Standard Product Labeling (SPL)/Prescribing Information SPL 1a9e0336-c0c2-43f8-aeea-668d4a209714 Details

Active ingredient (in each tablet)

Pseudoephedrine HCl 30 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 2 tablets every 4 to 6 hours • do not take more than 8 tablets in 24 hours
children ages 6 to 11 years	• take 1 tablet every 4 to 6 hours • do not take more than 4 tablets in 24 hours
children under 6 years	do not use this product in children under 6 years of age

Other information

•: each tablet contains: calcium 20 mg
•: store at 20°-25°C (68°-77°F)
•: do not use if blister unit is broken or torn

Inactive ingredients

carnauba wax, dibasic calcium phosphate dihydrate, FD&C red no. 40 aluminum lake, hypromellose, magnesium stearate, microcrystalline cellulose, polyethylene glycol, polysorbate 80, silicon dioxide, titanium dioxide

Questions or comments?

1-888-423-0139

Principal Display Panel

TopCare® health

COMPARE TO SUDAFED® CONGESTION ACTIVE INGREDIENT

NON-DROWSY

Nasal Decongestant

PSEUDOEPHEDRINE HYDROCHLORIDE TABLETS, 30 mg

MAXIMUM STRENGTH

• Sinus Pressure + Congestion

• Pseudoephedrine HCl

24 TABLETS

actual size

INGREDIENTS AND APPEARANCE

TOPCARE NASAL DECONGESTANT MAXIMUM STRENGTH NON DROWSY

pseudoephedrine hcl tablet, film coated

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:36800-432
Route of Administration	ORAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
PSEUDOEPHEDRINE HYDROCHLORIDE (UNII: 6V9V2RYJ8N) (PSEUDOEPHEDRINE - UNII:7CUC9DDI9F)	PSEUDOEPHEDRINE HYDROCHLORIDE	30 mg

Ingredient Name	Strength
Inactive Ingredients
CARNAUBA WAX (UNII: R12CBM0EIZ)
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)
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)
FD&C RED NO. 40 (UNII: WZB9127XOA)

Product Characteristics
Color	RED	Score	no score
Shape	ROUND (convex)	Size	7mm
Flavor		Imprint Code	L432
Contains

#	Item Code	Package Description	Marketing Start Date
Packaging
1	NDC:36800-432-62	24 in 1 CARTON	01/15/1988
1		1 in 1 BLISTER PACK; Type 0: Not a Combination Product
2	NDC:36800-432-67	48 in 1 CARTON	02/15/1990
2		1 in 1 BLISTER PACK; Type 0: Not a Combination Product
3	NDC:36800-432-80	96 in 1 CARTON	12/26/2019
3		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
OTC monograph final	part341	01/15/1988

Labeler - Topco Associates LLC (006935977)

Revised: 8/2022

Document Id: 4b199c18-a168-4aab-b4b6-b2bd16fa6488

Set id: 1a9e0336-c0c2-43f8-aeea-668d4a209714

Version: 7

Effective Time: 20220829