OTC Medication Information: Pseudoephedrine Hydrochloride

PSEUDOEPHEDRINE HYDROCHLORIDE- pseudoephedrine hydrochloride tablet, film coated
A-S Medication Solutions

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

Distributed by:
Ohm Laboratories Inc.
New Brunswick, NJ 08901

HOW SUPPLIED

Product: 50090-5554

NDC: 50090-5554-0 10 TABLET, FILM COATED in a BLISTER PACK

PSEUDOEPHEDRINE HYDROCHLORIDE

Label Image

PSEUDOEPHEDRINE HYDROCHLORIDE pseudoephedrine hydrochloride tablet, film coated

Product Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:50090-5554(NDC:51660-204) Route of Administration ORAL DEA Schedule

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

Inactive Ingredients Ingredient Name Strength CASTOR OIL SILICON DIOXIDE HYPROMELLOSE, UNSPECIFIED MICROCRYSTALLINE CELLULOSE 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 Multilevel Packaging 1 NDC:50090-5554-0 10 TABLET, FILM COATED in 1 BLISTER PACK None

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

Labeler — A-S Medication Solutions (830016429)

Establishment
Name	Address	ID/FEI	Operations
A-S Medication Solutions		830016429	RELABEL (50090-5554)

Revised: 09/2023 A-S Medication Solutions