Rapidol Naproxen NAPROXEN SODIUM PHARMADEL LLC FDA Approved Uses temporarily relieves minor aches and pains due to minor pain from arthritis menstrual cramps muscular aches headache backache toothache the common cold temporarily reduces fever
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Substance Naproxen Sodium
Route
ORAL
Applications
ANDA091353

Drug Facts

Composition & Profile

Active Ingredients
Active ingredient and Purposes Active ingredient (in each caplet) Purposes Naproxen sodium 220mg (naproxen 200mg) (NSAID*) Pain reliver/ fever reducer *nonsteroidal anti-inflammatory drug
Inactive Ingredients
Inactive ingredients corn starch FD&C blue #2 aluminum lake hypromellose microcrystalline cellulose polyethylene glycol povidone k30 sodium starch glycolate stearic acid titanium dioxide water
Strengths
220 mg 200 mg
Treats Conditions
Uses Temporarily Relieves Minor Aches And Pains Due To Minor Pain From Arthritis Menstrual Cramps Muscular Aches Headache Backache Toothache The Common Cold Temporarily Reduces Fever
Pill Appearance
Shape: oval Color: blue Imprint: 220

Identifiers & Packaging

Container Type UNKNOWN
UNII
9TN87S3A3C
Packaging

Prrinicpal Display Panel PDP NAPROXENO

Package Descriptions
  • Prrinicpal Display Panel PDP NAPROXENO

Overview

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

Indications & Usage

Uses temporarily relieves minor aches and pains due to minor pain from arthritis menstrual cramps muscular aches headache backache toothache the common cold 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 & children 12 years of age 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 to 12 hour period do not exceed 3 Tablets in a 24-hour period children under 12 years of age consult a doctor

Warnings & Precautions
Warnings Allergy a lert: Naproxen sodium may cause severe skin reactions. 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. 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 are taking a diuretic you have problems or serious side effects from taking pain relievers or fever reducers Ask a doctor or pharmacist before use if you are under a doctor’s care for any serious condition taking aspirin for heart attack or stroke, because naproxen may decrease this benefit of aspirin taking any other drugs 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: 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 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 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 at 20 weeks or later 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 (1-800-222-1222).
Purpose

Active ingredient (in each caplet) Purposes Naproxen sodium 220mg (naproxen 200mg) (NSAID*) Pain reliver/ 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

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 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 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 (1-800-222-1222).

Storage & Handling

Other information each caplet contains: sodium 20 mg store between 68-77°F (20-25°C). Avoid high humidity and excessive heat above 104°F (40°C)


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