PROXEN NP 660 NAPROXEN SODIUM OPMX LLC FDA Approved Uses ■ temporarily relieves minor aches and pains due to: ■ headache ■ backache ■ muscular aches ■ the common cold ■ toothache ■ menstrual cramps ■ minor pain of arthritis ■ temporarily reduces fever
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Substance Naproxen Sodium
Route
ORAL
Applications
ANDA091353

Drug Facts

Composition & Profile

Active Ingredients
Active ingredient (in each tablet) Purposes Naproxen sodium 220 mg (naproxen 200mg) (NSAID)* .........Pain reliever/fever reducer *nonsteroidal anti-inflammatory drug
Inactive Ingredients
Inactive ingredients colloidal silicon dioxide croscarmellose sodium FD&C Blue #2 lake hypromellose magnesium stearate microcrystalline cellulose polyethylene glycol povidone titanium dioxide
Strengths
220 mg 200 mg
Quantities
660 count
Treats Conditions
Uses Temporarily Relieves Minor Aches And Pains Due To Headache Backache Muscular Aches The Common Cold Toothache Menstrual Cramps Minor Pain Of Arthritis Temporarily Reduces Fever
Pill Appearance
Shape: oval Color: blue Imprint: 220

Identifiers & Packaging

Container Type UNKNOWN
UPC
0810053181362 0810053181379 0810053181423
UNII
9TN87S3A3C
Packaging

PRINCIPAL DISPLAY PANEL 12 CAPLETS NDC 69729-123-12 PROXEN NP 660 NAPROXEN SODIUM Arthritis/Artritis Backache/Dolor de Espalda Muscle and Joint Pain/ Dolor Muscular y de Articulaciones 12 Caplets Proxen; PRINCIPAL DISPLAY PANEL 24 CAPLETS NDC 69729-123-24 PROXEN NP 660 NAPROXEN SODIUM Arthritis/Artritis Backache/Dolor de Espalda Muscle and Joint Pain/ Dolor Muscular y de Articulaciones 24 Caplets Proxen 660 24; PRINCIPAL DISPLAY PANEL 100 CAPLETS NDC 69729-123-50 PROXEN NP 660 NAPROXEN SODIUM Arthritis/Artritis Backache/Dolor de Espalda Muscle and Joint Pain/ Dolor Muscular y de Articulaciones 100 Caplets P100

Package Descriptions
  • PRINCIPAL DISPLAY PANEL 12 CAPLETS NDC 69729-123-12 PROXEN NP 660 NAPROXEN SODIUM Arthritis/Artritis Backache/Dolor de Espalda Muscle and Joint Pain/ Dolor Muscular y de Articulaciones 12 Caplets Proxen
  • PRINCIPAL DISPLAY PANEL 24 CAPLETS NDC 69729-123-24 PROXEN NP 660 NAPROXEN SODIUM Arthritis/Artritis Backache/Dolor de Espalda Muscle and Joint Pain/ Dolor Muscular y de Articulaciones 24 Caplets Proxen 660 24
  • PRINCIPAL DISPLAY PANEL 100 CAPLETS NDC 69729-123-50 PROXEN NP 660 NAPROXEN SODIUM Arthritis/Artritis Backache/Dolor de Espalda Muscle and Joint Pain/ Dolor Muscular y de Articulaciones 100 Caplets P100

Overview

Uses ■ temporarily relieves minor aches and pains due to: ■ headache ■ backache ■ muscular aches ■ the common cold ■ toothache ■ menstrual cramps ■ minor pain of arthritis ■ temporarily reduces fever

Indications & Usage

Uses ■ temporarily relieves minor aches and pains due to: ■ headache ■ backache ■ muscular aches ■ the common cold ■ toothache ■ menstrual cramps ■ minor pain of arthritis ■ temporarily reduces fever

Dosage & Administration

Directions ■ do not take more than directed ■ the smallest effective dose should be used ■ drink a full glass of water with each dose Adults and children 12 years and older: ■ take 1 tablet every 8 to 12 hours while symptoms last ■ for the first dose you may take 2 tablets within the first hour ■ do not exceed 2 tablets in any 8 to12 hour period ■ do not exceed 3 tablets in a 24 hour period Children under 12 years ■ ask a doctor

Warnings & Precautions
Warnings Allergy alert: Naproxen sodium may cause a severe allergic reaction, especially in people allergic to aspirin. Symptoms may include: ■ hives ■ asthma (wheezing) ■ skin reddening ■ facial swelling ■ shock ■ 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 Do not use ■ if you have ever had an allergic reaction to any other pain reliever/fever reducer ■ right before or after heart surgery Ask a doctor before use if ■ the stomach bleeding warning applies to you ■ you have a history of stomach problems, such as heartburn ■ you have high blood pressure, heart disease, liver cirrhosis, or kidney disease ■ you are taking a diuretic ■ you have problems or serious side effects from taking pain relievers or fever reducers ■ you have asthma Ask a doctor or pharmacist before use if you are ■ under a doctor's care for any serious condition ■ taking any other drug When using this product ■ take with food or milk if stomach upset occurs ■ the risk of heart attack or stroke may increase if you use more than directed or for longer than directed Stop use and ask a doctor if ■ side effects occur. You may report side effects to FDA at 1-800-FDA-1088. ■ 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 ■ pain gets worse or lasts more than 10 days ■ fever gets worse or lasts more than 3 days ■ you have difficulty swallowing ■ it feels like the pill is stuck in your throat ■ redness or swelling is present in the painful area ■ any new symptoms appear If pregnant or breast-feeding , ask a health professional before use. It is especially important not to use naproxen sodium during the last 3 months of pregnancy unless definitely directed to do so by a doctor because it may cause problems in the unborn child or complications during delivery. Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center right away.
Purpose

Active ingredient (in each tablet) Purposes Naproxen sodium 220 mg (naproxen 200mg) (NSAID)* .........Pain reliever/fever reducer *nonsteroidal anti-inflammatory drug

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

When Using

When using this product ■ take with food or milk if stomach upset occurs ■ the risk of heart attack or stroke may increase if you use more than directed or for longer than directed

Stop Use & Ask a Doctor

Stop use and ask a doctor if ■ side effects occur. You may report side effects to FDA at 1-800-FDA-1088. ■ 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 ■ pain gets worse or lasts more than 10 days ■ fever gets worse or lasts more than 3 days ■ you have difficulty swallowing ■ it feels like the pill is stuck in your throat ■ redness or swelling is present in the painful area ■ any new symptoms appear

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.

Storage & Handling

Other information ■ each tablet contains: sodium 20 mg ■ store at 20-25° C (68-77° F). Avoid high humidity and excessive heat above 40° C (104° F) ■ read all product information before using ■ TAMPER EVIDENT: DO NOT USE IF IMPRINTED SAFETY SEAL UNDER CAP IS BROKEN OR MISSING.

Questions

Questions or comments? Call: (619) 600-5632 (Mon-Fri 9AM – 5PM EST) or https://www.opmx.us


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