CAREALL Naproxen NAPROXEN SODIUM NEW WORLD IMPORTS, INC. FDA Approved Uses Temporarily relieves minor aches and pains due to: minor pain of arthritis, backache, headache, muscular aches, menstrual cramps, toothache, common cold, temporarily reduces fever
FunFoxMeds box
Substance Naproxen Sodium
Route
ORAL
Applications
ANDA079096
Package NDC

Drug Facts

Composition & Profile

Active Ingredients
Active ingredients (in each caplet) Active ingredient (in each caplet) Naproxen sodium 220mg (Naproxen 200mg) (NSAID)* *nonsteroidal anti-inflammatory drug
Inactive Ingredients
Inactive ingredients croscarmellose sodium FD&C blue number 2 macrogol magnesium stearate polyvinyl alcohol povidone pregelatinized starch talc titanium dioxide
Strengths
220 mg 200 mg
Treats Conditions
Uses Temporarily Relieves Minor Aches And Pains Due To Minor Pain Of Arthritis Backache Headache Muscular Aches Menstrual Cramps Toothache Common Cold Temporarily Reduces Fever
Pill Appearance
Shape: oval Color: blue Imprint: 17

Identifiers & Packaging

Container Type UNKNOWN
All Product Codes
UPC
0085317006082
UNII
9TN87S3A3C
Packaging

NAPC220100

Package Descriptions
  • NAPC220100

Overview

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

Indications & Usage

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

Dosage & Administration

Directions 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 caplet every 8 to 12 hours while symptoms last For the first dose you may take 2 caplets within the first hour Do not exceed 2 caplets in any 8 - 12 hour period Do not exceed 3 caplets 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 NSAID, which may casue 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 everyday while using this product, take more or for a longer time than directed. Heart attack and stroke warning : NSAIDs, except aspirin, increase the rist 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 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 this product When using this product: Take with food or milk if stomach upset occurs. Ask a Doctor Ask a doctor before use if: The stomach bleeding warning applies to you You ahve 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 any other drugs
Purpose

Purpose Pain reliever / fever reducer

Do Not Use

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 When using this product: Take with food or milk if stomach upset occurs.

Stop Use & Ask a Doctor

Stop use and ask a doctor Stop use and ask a doctor if: You experience any of the following signs of stomach bleeding: you feel faint, vomit blood, have bloddy 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, or leg swelling 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 Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center immediately (1-800-222-1222).


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