Ana-Dent PAIN RELIEF NAPROXEN SODIUM BELMORA LLC FDA Approved Uses ■ temporarily relieves minor aches and pain due to: ■ headache ■ muscular aches ■ toothache ■ the common cold ■ backache ■ menstrual cramps ■ minor pain of arthritis ■ temporarily reduces fever
FunFoxMeds box
Substance Naproxen Sodium
Route
ORAL
Applications
ANDA205497
Package NDC

Drug Facts

Composition & Profile

Active Ingredients
Active ingredient (in each tablet) Naproxen sodium 220 mg (naproxen 200 mg) (NSAID)* *nonsteroidal anti-inflammatory drug
Inactive Ingredients
Inactive ingredients colloidal silicon dioxide FD & C Blue#2 Aluminum Lake hypromellose magnesium stearate microcrystalline cellulose polyethylene glycol povidone titanium dioxide talc
Strengths
220 mg 200 mg
Treats Conditions
Uses Temporarily Relieves Minor Aches And Pain Due To Headache Muscular Aches Toothache The Common Cold Backache Menstrual Cramps Minor Pain Of Arthritis Temporarily Reduces Fever

Identifiers & Packaging

Container Type UNKNOWN
All Product Codes
UNII
9TN87S3A3C
Packaging

Packaging Flx701

Package Descriptions
  • Packaging Flx701

Overview

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

Indications & Usage

Uses ■ temporarily relieves minor aches and pain due to: ■ headache ■ muscular aches ■ toothache ■ the common cold ■ backache ■ 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 to12 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: 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: ■ shock ■ facial swelling ■ asthma (wheezing) ■ hives ■ skin reddening ■ blisters ■ rash 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 ■ have had stomach ulcers or bleeding problems ■ take blood thinning (anticoagulant) or steroid drug ■ are age 60 or older ■ take other drugs containing prescription or nonprescription NSAIDs [aspirin, ibuprofen, naproxen, or others] ■ take more or for a longer time than directed ■ have 3 or more alcoholic drinks every day while using this product. Do not use ■ right before or after heart surgery ■ if you have ever had an allergic reaction to any other pain reliever/fever reducer 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 asthma ■ you have high blood pressure, heart disease, liver cirrhosis or kidney disease ■ you have a problems or serious side effects from taking pain relievers or fever reducers ■ 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 ■ 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 ■ 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 (1-800-222-1222) right away.
Purpose

Purpose Pain reliever/ fever reducer

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 20°-25°C (68°-77°F). Avoid high humidity and excessive heat above 40°C (104°F) ■ see end flap for expiration date and lot number

Questions

Questions or comments? Call 1-888-779-2877 M-F 9AM-5PM EST


Similar Drugs

Related medications based on brand, generic name, substance, active ingredients.

View all similar drugs →