Drug Facts
Composition & Profile
Identifiers & 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
- 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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