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NDC 46122-0166-60 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 Amerisource Bergen. 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: 46122-0166-60
Last Updated: 11/30/2022
MedLinePlus Full Drug Details: Pseudoephedrine

Product Information

NDC	46122-0166
Product ID	46122-166_8b44b9ef-7b42-44da-b3cf-ad53f2a2ecdd
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 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	Amerisource Bergen
Pharmaceutical Class	Adrenergic alpha-Agonists [MoA], alpha-Adrenergic Agonist [EPC]
DEA Schedule	n/a
Marketing Category	ANDA
Application Number	ANDA077442
Listing Certified Through	2024-12-31

Package

Package Images

NDC 46122-0166-60 (46122016660)

Pricing Information
NDC Package Code	46122-166-60
Billing NDC	46122016660
Package	20 TABLET, FILM COATED, EXTENDED RELEASE in 1 BLISTER PACK (46122-166-60)
Marketing Start Date	2006-04-28
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 34885466-1b89-46b6-9257-07067b111ec6 Details

SPL UNCLASSIFIED SECTION

Drug Facts

Active ingredient (in each tablet)

Pseudoephedrine HCl, USP 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

store at 59° to 77° F in a dry place. Protect from light
TAMPER EVIDENT: DO NOT USE IF BLISTER UNITS ARE TORN, BROKEN OR SHOW ANY SIGNS OF TAMPERING.

Inactive ingredients

castor oil, colloidal silicon dioxide, hypromellose, microcrystalline cellulose, magnesium stearate, titanium dioxide

Questions?

call 1-800-406-7984

SPL UNCLASSIFIED SECTION

Distributed By:

AmerisourceBergen

1 West First Avenue

Conshohocken, PA 19428

PRINCIPAL DISPLAY PANEL - 120 mg Tablet Blister Pack Carton

GOOD

NEIGHBOR

PHARMACY®

Compare to active ingredient in

Sudafed® 12 hour*

NDC 46122-166-60

12 HOUR

Non-Drowsy

Pseudoephedrine

Hydrochloride 120 mg

Extended-Release Tablets, USP

Long-Acting Nasal Decongestant

SINUS PRESSURE + CONGESTION
MAXIMUM STRENGTH

20 Coated Capsule-Shaped Tablets 120 mg Each

PRINCIPAL DISPLAY PANEL - 120 mg Tablet Blister Pack Carton

INGREDIENTS AND APPEARANCE

PSEUDOEPHEDRINE HYDROCHLORIDE

pseudoephedrine hydrochloride tablet, film coated, extended release

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:46122-166
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
CASTOR OIL (UNII: D5340Y2I9G)
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
HYPROMELLOSE, UNSPECIFIED (UNII: 3NXW29V3WO)
MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U)
MAGNESIUM STEARATE (UNII: 70097M6I30)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)

Product Characteristics
Color	white	Score	no score
Shape	CAPSULE	Size	18mm
Flavor		Imprint Code	204
Contains

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:46122-166-60	20 in 1 BLISTER PACK; Type 0: Not a Combination Product	04/28/2006

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
ANDA	ANDA077442	04/28/2006

Labeler - Amerisource Bergen (007914906)

Name	Address	ID/FEI	Business Operations
Establishment
Ohm Laboratories Inc.		051565745	manufacture(46122-166)

Revised: 6/2021

Document Id: 8b44b9ef-7b42-44da-b3cf-ad53f2a2ecdd

Set id: 34885466-1b89-46b6-9257-07067b111ec6

Version: 4

Effective Time: 20210616

Search by Drug Name or NDC

NDC 46122-0166-60 Pseudoephedrine Hydrochloride 120 mg/1 Details

Pseudoephedrine Hydrochloride 120 mg/1

MedlinePlus Drug Summary

Product Information

Package

Package Images

NDC 46122-0166-60 (46122016660)

Contents

Standard Product Labeling (SPL)/Prescribing Information SPL 34885466-1b89-46b6-9257-07067b111ec6 Details

SPL UNCLASSIFIED SECTION

Active ingredient (in each tablet)

Purpose

Uses

Warnings

Ask a doctor before use if you have

Stop use and ask a doctor if

Directions

Other information

Inactive ingredients

Questions?

SPL UNCLASSIFIED SECTION

PRINCIPAL DISPLAY PANEL - 120 mg Tablet Blister Pack Carton

INGREDIENTS AND APPEARANCE

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