equate sinus 12 hour PSEUDOEPHEDRINE HYDROCHLORIDE WAL-MART STORES 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
ANDA075153
Package NDC

Drug Facts

Composition & Profile

Active Ingredients
Active ingredient (in each tablet) Pseudoephedrine HCl 120 mg
Inactive Ingredients
Inactive ingredients carnauba wax colloidal silicon dioxide dibasic calcium phosphate dihydrate hypromellose magnesium stearate microcrystalline cellulose polyethylene glycol polysorbate 80 titanium dioxide
Strengths
120 mg
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: oval Color: white Imprint: L054

Identifiers & Packaging

Container Type UNKNOWN
All Product Codes
UNII
6V9V2RYJ8N
Packaging

Principal Display Panel Compare to Sudafed ® Sinus Congestion 12 Hour Caplets active ingredient NON-DROWSY Sinus 12 Hour Pseudoephedrine Hydrochloride Extended Release Tablets, 120 mg 12 HOUR Nasal Decongestant MAXIMUM STRENGTH Congestion Sinus pressure Actual Size 20 COATED CAPLETS* *Capsule-Shaped Tablets Sinus 12 hour image

Package Descriptions
  • Principal Display Panel Compare to Sudafed ® Sinus Congestion 12 Hour Caplets active ingredient NON-DROWSY Sinus 12 Hour Pseudoephedrine Hydrochloride Extended Release Tablets, 120 mg 12 HOUR Nasal Decongestant MAXIMUM STRENGTH Congestion Sinus pressure Actual Size 20 COATED CAPLETS* *Capsule-Shaped Tablets Sinus 12 hour image

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 • each tablet contains: calcium 45 mg • store at 20-25°C (68-77°F) in a dry place • protect from light • do not use if blister unit is broken or torn • see carton end panel for lot number and expiration date • this product meets the requirements of USP Drug Release Test 3

Questions

Questions or comments? 1-888-287-1915


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