All Day Pain Relief NAPROXEN SODIUM P & L DEVELOPMENT, LLC FDA Approved Uses temporarily relieves minor aches and pains due to: backache muscular aches minor pain of arthritis menstrual cramps headache toothache the common cold temporarily reduces fever
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Substance Naproxen Sodium
Route
ORAL
Applications
ANDA079096

Drug Facts

Composition & Profile

Active Ingredients
Active ingredient (in each tablet) Naproxen sodium 220 USP mg (naproxen 200 mg) (NSAID)* *nonsteroidal anti-inflammatory drug
Inactive Ingredients
Inactive ingredients croscarmellose sodium FD&C blue # 2 macrogol magnesium stearate polyvinyl alcohol povidone pregelatinized starch talc titanium dioxide
Strengths
200 mg
Treats Conditions
Uses Temporarily Relieves Minor Aches And Pains Due To Backache Muscular Aches Minor Pain Of Arthritis Menstrual Cramps Headache Toothache The Common Cold Temporarily Reduces Fever
Pill Appearance
Shape: round Color: blue Imprint: I3

Identifiers & Packaging

Container Type UNKNOWN
UPC
0359726169400
UNII
9TN87S3A3C
Packaging

Package Labeling READYinCASE All Day Pain Relief Naproxen sodium 220 mg (naproxen 200 mg) (NSAID)* *nonsteroidal anti-inflammatory drug

Package Descriptions
  • Package Labeling READYinCASE All Day Pain Relief Naproxen sodium 220 mg (naproxen 200 mg) (NSAID)* *nonsteroidal anti-inflammatory drug

Overview

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

Indications & Usage

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

Dosage & Administration

Directions do not make 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 a any 8- to 12-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 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 have 3 or more alcoholic drinks every day while using this product take other drugs containing prescription or nonprescription NSAIDs (aspirin, ibuprofen, naproxen, or others) 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 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, kidney disease, asthma, or had a stroke you have problems or serious side effects from taking pain relievers or fever reducers you are taking a diuretic you are taking a diuretic 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 Stop use and ask a doctor if you experience any of the following signs of stomach bleeding: have bloody or black stools feel faint vomit blood have stomach pain that does not get better you have symptoms of heart problem or stroke: chest pain trouble breathing slurred speech leg swelling weakness in one part or side of body pain gets worse or lasts more than 10 days fever gets worse or lasts more than 3 days redness or swelling is present in the painful area any new symptoms appear you have difficulty swallowing it feels like the pill is stuck in your throat 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 (1-800-222-1222) right away.
Purpose

Purposes Pain reliever/fever reducer

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

Stop Use & Ask a Doctor

Stop use and ask a doctor if you experience any of the following signs of stomach bleeding: have bloody or black stools feel faint vomit blood have stomach pain that does not get better you have symptoms of heart problem or stroke: chest pain trouble breathing slurred speech leg swelling weakness in one part or side of body pain gets worse or lasts more than 10 days fever gets worse or lasts more than 3 days redness or swelling is present in the painful area any new symptoms appear you have difficulty swallowing it feels like the pill is stuck in your throat

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 (1-800-222-1222) right away.

Storage & Handling

Other information each tablet contains: sodium 20 mg store at 20º to 25ºC (68º to 77ºF). Avoid high humidity and excessive heat above 40ºC (104ºF). Protect from light.

Questions

Questions or comments? Call 1-877-753-3935 Monday-Friday 9AM-5PM EST


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