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NDC 51660-0492-21 Pseudoephedrine hydrochloride 120 mg/1 Details

Pseudoephedrine hydrochloride 120 mg/1

Pseudoephedrine hydrochloride is a ORAL TABLET, EXTENDED RELEASE in the HUMAN OTC DRUG category. It is labeled and distributed by Ohm Laboratories Inc.. 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: 51660-0492-21
Last Updated: 11/30/2022
MedLinePlus Full Drug Details: Pseudoephedrine

Product Information

NDC	51660-0492
Product ID	51660-492_060dbf55-8c1c-4c02-98e2-83cd6c0bd3fc
Associated GPIs
GCN Sequence Number	n/a
GCN Sequence Number Description	n/a
HIC3	n/a
HIC3 Description	n/a
GCN	n/a
HICL Sequence Number	n/a
HICL Sequence Number Description	n/a
Brand/Generic	n/a
Proprietary Name	Pseudoephedrine hydrochloride
Proprietary Name Suffix	n/a
Non-Proprietary Name	pseudoephedrine hydrochloride
Product Type	HUMAN OTC DRUG
Dosage Form	TABLET, EXTENDED RELEASE
Route	ORAL
Active Ingredient Strength	120
Active Ingredient Units	mg/1
Substance Name	PSEUDOEPHEDRINE HYDROCHLORIDE
Labeler Name	Ohm Laboratories Inc.
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 51660-0492-21 (51660049221)

Pricing Information	N/A
NDC Package Code	51660-492-21
Billing NDC	51660049221
Package	20 TABLET, EXTENDED RELEASE in 1 BLISTER PACK (51660-492-21)
Marketing Start Date	2006-04-28
NDC Exclude Flag	N

Standard Product Labeling (SPL)/Prescribing Information SPL f398ceab-e3d2-421d-813e-b66369f65472 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:

Ohm Laboratories Inc.

New Brunswick, NJ 08901

PRINCIPAL DISPLAY PANEL - 20 Tablet Blister Pack

†Compare To

the active ingredient of

Sudafed® 12 Hour.

NDC 51660-492-21

ohm®

NON-DROWSY

Pseudoephedrine

Hydrochloride 120 mg

12 Hour Extended-Release Tablets, USP

Long-Acting Nasal Decongestant

SINUS PRESSURE + CONGESTION
MAXIMUM STRENGTH

20 Coated Capsule-Shaped Tablets 120 mg Each

PRINCIPAL DISPLAY PANEL - 20 Tablet Blister Pack

INGREDIENTS AND APPEARANCE

PSEUDOEPHEDRINE HYDROCHLORIDE

pseudoephedrine hydrochloride tablet, extended release

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:51660-492
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:51660-492-21	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 - Ohm Laboratories Inc. (184769029)

Registrant - Ohm Laboratories Inc. (184769029)

Name	Address	ID/FEI	Business Operations
Establishment
Ohm Laboratories Inc.		051565745	manufacture(51660-492)

Revised: 5/2019

Document Id: 060dbf55-8c1c-4c02-98e2-83cd6c0bd3fc

Set id: f398ceab-e3d2-421d-813e-b66369f65472

Version: 2

Effective Time: 20190501

Search by Drug Name or NDC

NDC 51660-0492-21 Pseudoephedrine hydrochloride 120 mg/1 Details

Pseudoephedrine hydrochloride 120 mg/1

MedlinePlus Drug Summary

Product Information

Package

Package Images

NDC 51660-0492-21 (51660049221)

Contents

Standard Product Labeling (SPL)/Prescribing Information SPL f398ceab-e3d2-421d-813e-b66369f65472 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 - 20 Tablet Blister Pack

INGREDIENTS AND APPEARANCE

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