NAPROXEN SODIUM AND PSEUDOEPHEDRINE HYDROCHLORIDE COLD AND SINUS NAPROXEN SODIUM AND PSEUDOEPHEDRINE HYDROCHLORIDE VESPYR BRANDS, INC. FDA Approved Uses temporarily relieves these cold, sinus, and flu symptoms: sinus pressure minor body aches and pains headache nasal and sinus congestion (promotes sinus drainage and restores freer breathing through the nose) fever
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Substance Naproxen Sodium
Route
ORAL
Applications
ANDA211360
Package NDC

Drug Facts

Composition & Profile

Active Ingredients
Active ingredients (in each caplet) Naproxen sodium USP 220 mg (naproxen 200 mg) (NSAID)* Pseudoephedrine Hydrochloride USP 120 mg extended-release *nonsteroidal anti-inflammatory drug
Inactive Ingredients
Inactive ingredients Colloidal silicon dioxide croscarmellose sodium ferric oxide hypromellose lactose monohydrate magnesium stearate microcrystalline cellulose polyethylene glycol povidone talc and titanium dioxide.
Strengths
220 mg 200 mg 120 mg
Quantities
24 count
Treats Conditions
Uses Temporarily Relieves These Cold Sinus And Flu Symptoms Sinus Pressure Minor Body Aches And Pains Headache Nasal And Sinus Congestion Promotes Sinus Drainage And Restores Freer Breathing Through The Nose Fever
Pill Appearance
Shape: capsule Color: white Imprint: L95

Identifiers & Packaging

Container Type BOX
All Product Codes
UNII
9TN87S3A3C 6V9V2RYJ8N
Packaging

PACKAGE LABEL-PRINCIPAL DISPLAY PANEL - 220 mg / 120 mg 24 Caplets (Capsule-Shaped Tablets) Blister Carton Label NDC 71179-816-24 12 HOUR CONTAC-D ™ COLD & SINUS Naproxen Sodium 220 mg & Pseudoephedrine HCL 120 mg Pain Reliever/Fever Reducer (NSAID) & Nasal Decongestant MAXIMUM STRENGTH Headache, Fever, Sore Throat, Body Aches Sinus/Nasal Congestion & Pressure 24 EXTENDED-RELEASE CAPLETS Naproxen Figure

Package Descriptions
  • PACKAGE LABEL-PRINCIPAL DISPLAY PANEL - 220 mg / 120 mg 24 Caplets (Capsule-Shaped Tablets) Blister Carton Label NDC 71179-816-24 12 HOUR CONTAC-D ™ COLD & SINUS Naproxen Sodium 220 mg & Pseudoephedrine HCL 120 mg Pain Reliever/Fever Reducer (NSAID) & Nasal Decongestant MAXIMUM STRENGTH Headache, Fever, Sore Throat, Body Aches Sinus/Nasal Congestion & Pressure 24 EXTENDED-RELEASE CAPLETS Naproxen Figure

Overview

Uses temporarily relieves these cold, sinus, and flu symptoms: sinus pressure minor body aches and pains headache nasal and sinus congestion (promotes sinus drainage and restores freer breathing through the nose) fever

Indications & Usage

Uses temporarily relieves these cold, sinus, and flu symptoms: sinus pressure minor body aches and pains headache nasal and sinus congestion (promotes sinus drainage and restores freer breathing through the nose) fever

Dosage & Administration

Directions do not take more than directed the smallest effective dose should be used swallow whole; do not crush or chew drink a full glass of water with each dose adults and children 12 years and older: 1 caplet every 12 hours; do not take more than 2 caplets in 24 hours children under 12 years: do not use

Warnings & Precautions
Warnings Allergy alert: Naproxen sodium may cause a severe allergic reaction, especially in people allergic to aspirin. Symptoms may include: hives facial swelling asthma (wheezing) shock skin reddening rash blisters If an allergic reaction occurs, stop use and seek medical help right away. Stomach bleeding warning: This product contains an NSAID, which may cause severe stomach bleeding. The chance is higher if you: are age 60 or older have had stomach ulcers or bleeding problems take a blood thinning (anticoagulant) or steroid drug take other drugs containing prescription or nonprescription NSAIDs (aspirin, ibuprofen, naproxen, or others) have 3 or more alcoholic drinks every day while using this product take more or for a longer time than directed Heart attack and stroke warning: NSAIDs, except aspirin, increase the risk of heart attack, heart failure, and stroke. These can be fatal. The risk is higher if you use more than directed or for longer than directed.
Purpose

Purposes Pain reliever/fever reducer Nasal decongestant

Do Not Use

Do not use if you have ever had an allergic reaction to any other pain reliever/fever reducer right before or after heart surgery 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. in children under 12 years of age

When Using

When using this product take with food or milk if stomach upset occurs

Stop Use & Ask a Doctor

Stop use and ask a doctor if you experience any of the following signs of stomach bleeding: feel faint vomit blood have bloody or black stools have stomach pain that does not get better you have symptoms of heart problems or stroke: chest pain trouble breathing weakness in one part or side of body slurred speech leg swelling redness or swelling is present in the painful area any new symptoms appear fever gets worse or lasts more than 3 days you have difficulty swallowing or the caplet feels stuck in your throat you get nervous, dizzy, or sleepless nasal congestion lasts more than 7 days

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 caplet contains: sodium 22 mg store at 20° to 25°C (68° to 77°F) store in a dry place Meets USP dissolution test 3.

Questions

Questions or comments? call 1 (855) 874-0970 (Monday – Friday 8A to 5P EST) DISTRIBUTED BY: Vespyr Brands ® , LLC., East Windsor NJ 08520 © 2025 Vespyr Brands ® , LLC. All rights reserved Contac ® is a registered trademark of Vespyr Brands ® , LLC. www.contac.com Made in India


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