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NDC 45802-0107-52 pseudoephedrine hydrochloride 120 mg/1 Details

pseudoephedrine hydrochloride 120 mg/1

pseudoephedrine hydrochloride is a ORAL TABLET, FILM COATED, EXTENDED RELEASE in the HUMAN OTC DRUG category. It is labeled and distributed by Padagis Israel Pharmaceuticals Ltd. 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: 45802-0107-52
Last Updated: 11/30/2022
MedLinePlus Full Drug Details: Pseudoephedrine

Product Information

NDC	45802-0107
Product ID	45802-107_545032a9-6307-402e-9cb4-1cf5174679c7
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	pseudoephedrine hydrochloride
Proprietary Name Suffix	n/a
Non-Proprietary Name	Pseudoephedrine HCl
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	Padagis Israel Pharmaceuticals Ltd
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 45802-0107-52 (45802010752)

Pricing Information
NDC Package Code	45802-107-52
Billing NDC	45802010752
Package	10 BLISTER PACK in 1 CARTON (45802-107-52) / 1 TABLET, FILM COATED, EXTENDED RELEASE in 1 BLISTER PACK
Marketing Start Date	2014-05-24
NDC Exclude Flag	N
Price Per Unit	0.27385
Pricing Unit	EA
Effective Date	2024-02-21
NDC Description	PSEUDOEPHEDRINE ER 120 MG TAB
Pharmacy Type Indicator	C/I
OTC	Y
Explanation Code	1
Classification for Rate Setting	G
As of Date	2024-02-21

This pricing file, entitled the NADAC (National Average Drug Acquisition Cost) files, provide state Medicaid agencies with covered outpatient drug prices by averaging survey invoice prices from retail community pharmacies across the United States. These pharmacies include independent retail community pharmacies and chain pharmacies. The prices are updated on a weekly and monthly basis

Standard Product Labeling (SPL)/Prescribing Information SPL 4a4da1e6-2ad1-47f7-a9b3-7d845962ef3b 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?

1-800-719-9260

Principal Display Panel

Compare to Sudafed® Sinus Congestion 12 Hour active ingredient

Pseudoephedrine Hydrochloride Extended Release Tablets 120 mg

Nasal Decongestant

Maximum Strength – Non-Drowsy

Sinus Pressure – Congestion

10 COATED CAPLETS*

120 mg EACH

actual size

*(Capsule-shaped Tablets)

12 Hour Sinus

INGREDIENTS AND APPEARANCE

PSEUDOEPHEDRINE HYDROCHLORIDE

pseudoephedrine hcl tablet, film coated, extended release

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:45802-107
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:45802-107-52	10 in 1 CARTON	05/24/2014
1		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	05/24/2014

Labeler - Padagis Israel Pharmaceuticals Ltd (600093611)

Revised: 11/2021

Document Id: 545032a9-6307-402e-9cb4-1cf5174679c7

Set id: 4a4da1e6-2ad1-47f7-a9b3-7d845962ef3b

Version: 4

Effective Time: 20211104