Pseudoephedrine hydrochloride PSEUDOEPHEDRINE HYDROCHLORIDE OHM LABORATORIES INC. FDA Approved Uses temporarily relieves nasal congestion due to the common cold, hay fever or other upper respiratory allergies temporarily relieves sinus congestion and pressure
FunFoxMeds box
Route
ORAL
Applications
ANDA077442
Package NDC

Drug Facts

Composition & Profile

Active Ingredients
Active ingredient (in each tablet) Pseudoephedrine HCl USP 120 mg
Inactive Ingredients
Inactive ingredients castor oil colloidal silicon dioxide hypromellose microcrystalline cellulose magnesium stearate titanium dioxide
Strengths
120 mg
Quantities
20 tablet
Treats Conditions
Uses Temporarily Relieves Nasal Congestion Due To The Common Cold Hay Fever Or Other Upper Respiratory Allergies Temporarily Relieves Sinus Congestion And Pressure
Pill Appearance
Shape: capsule Color: white Imprint: 204

Identifiers & Packaging

Container Type BOX
All Product Codes
UNII
6V9V2RYJ8N
Packaging

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

Package Descriptions
  • 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

Overview

Uses temporarily relieves nasal congestion due to the common cold, hay fever or other upper respiratory allergies temporarily relieves sinus congestion and pressure

Indications & Usage

Uses temporarily relieves nasal congestion due to the common cold, hay fever or other upper respiratory allergies temporarily relieves sinus congestion and pressure

Dosage & Administration

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

Warnings & Precautions
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)
Purpose

Purpose Nasal decongestant

Do Not Use

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.

When Using

When using this product do not exceed recommended dosage

Stop Use & Ask a Doctor

Stop use and ask a doctor if nervousness, dizziness, or sleeplessness occur symptoms do not improve within 7 days or occur with a fever

Keep Out of Reach of Children

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)

Storage & Handling

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.

Questions

Questions? call 1-800-406-7984


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