RxNorm Names

Review RxNorm Normal Forms

PSEUDOEPHEDRINE HYDROCHLORIDE tablet, extended release
[Ohm Laboratories Inc.]

Permanent Link:

http://dailymed.nlm.nih.gov/dailymed/lookup.cfm?setid=f398ceab-e3d2-421d-813e-b66369f65472

Category	DEA Schedule	Marketing Status
HUMAN OTC DRUG LABEL		Abbreviated New Drug Application

Drug Label Sections

Description
Clinical Pharmacology
Indications & Usage
Contraindications
Warnings
Precautions
Adverse Reactions
Overdosage
Dosage & Administration
How Supplied
Patient Counseling Information
Supplemental Patient Material
Boxed Warning
Patient Package Insert
Highlights
Full Table of Contents
Medication Guide

ACTIVE INGREDIENT (IN EACH TABLET)

Pseudoephedrine HCl USP, 120 mg

PURPOSE

Nasal decongestant

USES

temporarily relieves nasal congestion due to:

common cold
hay fever
upper respiratory allergies
temporarily restores freer breathing through the nose
promotes nasal and/or sinus drainage
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
diabetes
thyroid disease
trouble urinating due to an enlarged prostate gland

When using this product

do not use more than directed

Stop use and ask a doctor if

symptoms do not get better within 7 days or occur with a fever
you get nervous, dizzy, or sleepless

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.

DIRECTIONS

adults and children 12 years and older: 1 tablet every 12 hours; not more than 2 tablets in 24 hours
children under 12 years: ask a doctor

OTHER INFORMATION

store at 59o to 77oF in a dry place
protect from light

INACTIVE INGREDIENTS

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

QUESTIONS?

call 1-800-406-7984

Keep the Carton. It contains important information.

See end panel for expiration date.

TAMPER EVIDENT: DO NOT USE IF BLISTER UNITS ARE TORN, BROKEN OR SHOW ANY SIGNS OF TAMPERING.

Distributed by:

Ohm Laboratories Inc.

1385 Livingston Avenue

North Brunswick, NJ 08902

PRINCIPAL DISPLAY PANEL

†Compare to the active ingredient of SUDAFED®12 HOUR.

NDC 51660-492-21

Pseudoephedrine Hydrochloride 120 mg Extended-Release Tablets, USP

Long-Acting Nasal Decongestant

20Coated Capsule-Shaped Tablets

120 mg Each

12 Hour

Nasal & Sinus Congestion due to Colds & Allergies

Sinus Pressure

†This product is not manufactured or distributed by Johnson & Johnson Corporation, owner ofthe registered trademark SUDAFED® 12 HOUR.

20's blister carton

PSEUDOEPHEDRINE HYDROCHLORIDE
pseudoephedrine hydrochloride tablet, extended release

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:51660-492
Route of Administration	ORAL	DEA Schedule

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
PSEUDOEPHEDRINE HYDROCHLORIDE (PSEUDOEPHEDRINE)	PSEUDOEPHEDRINE	120 mg

Inactive Ingredients
Ingredient Name	Strength
CASTOR OIL
COLLOIDAL SILICON DIOXIDE
HYPROMELLOSES
CELLULOSE, MICROCRYSTALLINE
MAGNESIUM STEARATE
TITANIUM DIOXIDE

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

Packaging
#	Item Code	Package Description
1	NDC:51660-492-21	20 in 1 BLISTER PACK

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

Labeler - Ohm Laboratories Inc. (184769029)

Registrant - Ohm Laboratories Inc. (184769029)

Establishment
Name	Address	ID/FEI	Business Operations
Ohm Laboratories Inc.		051565745	manufacture

Revised: 01/2012

Document Id: f398ceab-e3d2-421d-813e-b66369f65472

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

Version: 1

Effective Time: 20120120