Pseudoephedrine HCl PSEUDOEPHEDRINE HCL BETTER LIVING BRANDS LLC 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
ANDA209008
Package NDC

Drug Facts

Composition & Profile

Active Ingredients
Active ingredient (in each tablet) Pseudoephedrine HCl USP 120 mg
Inactive Ingredients
Inactive ingredients colloidal silicon dioxide dibasic calcium phosphate dihydrate hydroxypropyl cellulose hypromellose lactose monohydrate magnesium stearate microcrystalline cellulose talc and titanium dioxide.
Strengths
120 mg
Quantities
67 count
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: 70;T

Identifiers & Packaging

Container Type BOX
All Product Codes
UPC
0387730788560
UNII
6V9V2RYJ8N
Packaging

PACKAGE LABEL-PRINCIPAL DISPLAY PANEL - 120 mg, Blister Carton 20 (2 X 10) Extended-Release Tablets Compare to the Sudafed ® 12 Hour** active ingredient NDC 21130-158-67 12 HOUR MAXIMUM STRENGTH Long-Acting Nasal Decongestant PSEUDOEPHEDRINE HCl Extended-Release Tablets USP 120 mg • SINUS PRESSURE • CONGESTION • NON-DROWSY 20 COATED CAPLETS* 120 mg EACH *CAPSULE-SHAPED TABLETS PACKAGE LABEL-PRINCIPAL DISPLAY PANEL - 120 mg, Blister Carton 20 (2 X 10) Extended-Release Tablets

Package Descriptions
  • PACKAGE LABEL-PRINCIPAL DISPLAY PANEL - 120 mg, Blister Carton 20 (2 X 10) Extended-Release Tablets Compare to the Sudafed ® 12 Hour** active ingredient NDC 21130-158-67 12 HOUR MAXIMUM STRENGTH Long-Acting Nasal Decongestant PSEUDOEPHEDRINE HCl Extended-Release Tablets USP 120 mg • SINUS PRESSURE • CONGESTION • NON-DROWSY 20 COATED CAPLETS* 120 mg EACH *CAPSULE-SHAPED TABLETS PACKAGE LABEL-PRINCIPAL DISPLAY PANEL - 120 mg, Blister Carton 20 (2 X 10) Extended-Release Tablets

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
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 Each tablet contains: calcium 36 mg store at 20° to 25°C (68° to 77°F). Protect from light. do not use if the individual blister unit is open or torn see side panel for lot number and expiration date Meets USP dissolution test 4

Questions

Questions or comments? call 1-855-274-4122 DISTRIBUTED BY: BETTER LIVING BRANDS LLC P.O.BOX 99 PLEASANTON, CA 94566-0009 ‡1-888-723-3929 Made in India Code: TS/DRUGS/22/2009


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