NAPROXEN SODIUM NAPROXEN SODIUM HUMANWELL PURACAP PHARMACEUTICALS (WUHAN) CO., LTD FDA Approved Uses temporarily relieves minor aches and pains due to: minor pain of arthritis muscular aches backache menstrual cramps headache toothache the common cold temporarily reduces fever
FunFoxMeds box
Substance Naproxen Sodium
Route
ORAL
Applications
ANDA208363
Package NDC

Drug Facts

Composition & Profile

Active Ingredients
Active ingredient (in each capsule) Naproxen sodium 220 mg (naproxen 200 mg) (NSAID)* *nonsteroidal anti-inflammatory drug
Inactive Ingredients
Inactive ingredients FD&C blue#1 gelatin glycerin lactic acid lecithin light mineral oil n-butyl alcohol polyethylene glycol povidone propylene glycol purified water shellac glaze sorbitol sorbitan solution titanium dioxide white ink
Strengths
220 mg 200 mg
Quantities
000 capsules
Treats Conditions
Uses Temporarily Relieves Minor Aches And Pains Due To Minor Pain Of Arthritis Muscular Aches Backache Menstrual Cramps Headache Toothache The Common Cold Temporarily Reduces Fever

Identifiers & Packaging

Container Type UNKNOWN
All Product Codes
UNII
9TN87S3A3C
Packaging

PRINCIPAL DISPLAY PANEL - Shipping Label Naproxen Sodium 220 mg Bulk NDC: 53345-042-01 Each softgel contains: Naproxen Sodium 220 mg CAUTION: FOR FURTHER MANUFACTURING, PROCESSING OR REPACKAGING Quantity: 5,000 Capsules MADE IN CHINA IMPORTANT: 1.Inspect immediately upon receipt. 2.This is a bulk shipment, intended for further processing only. 3.Protect from heat, humidity, and light. Do not refrigerate. 4.Store at 20-25°C (68-77°F) and avoid excessive heat above 40°C (104°F). Shipping Label for Wuhan Shipping Label for PLD

Package Descriptions
  • PRINCIPAL DISPLAY PANEL - Shipping Label Naproxen Sodium 220 mg Bulk NDC: 53345-042-01 Each softgel contains: Naproxen Sodium 220 mg CAUTION: FOR FURTHER MANUFACTURING, PROCESSING OR REPACKAGING Quantity: 5,000 Capsules MADE IN CHINA IMPORTANT: 1.Inspect immediately upon receipt. 2.This is a bulk shipment, intended for further processing only. 3.Protect from heat, humidity, and light. Do not refrigerate. 4.Store at 20-25°C (68-77°F) and avoid excessive heat above 40°C (104°F). Shipping Label for Wuhan Shipping Label for PLD

Overview

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

Indications & Usage

Uses temporarily relieves minor aches and pains due to: minor pain of arthritis muscular aches backache menstrual cramps headache 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 if taken with food, this product may take longer to work adults and children 12 years and older: take 1 capsule every 8 to 12 hours while symptoms last for the first dose you may take 2 capsules within the first hour do not exceed 2 capsules in any 8- to 12-hour period do not exceed 3 capsules 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 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.
Purpose

Purposes Pain reliever/fever reducer 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: 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 weakness in one part or side of body slurred speech leg swelling 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 capsule 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 right away.

Storage & Handling

Other information each capsule 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 directions and warnings before use. Keep carton.

Questions

Questions or comments? Call toll free: 1-855-215-8180


Similar Drugs

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

View all similar drugs →