NAPROXEN SODIUM tablet, film coated

Drug Details [pdf]

Naproxen Sodium Tablets, USP 220 mg

Drug Facts
Active ingredient (in each tablet)

Naproxen sodium USP 220 mg (naproxen 200 mg) (NSAID)*

*nonsteroidal anti-inflammatory drug
Purposes

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

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 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	ask a doctor

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

colloidal silicon dioxide, FD&C blue #2 aluminum lake, hypromellose, magnesium stearate, microcrystalline cellulose, polyethylene glycol, povidone, talc, and titanium dioxide
Questions or comments?

1-855-274-4122

Distributed by: AUROHEALTH LLC
2572 Brunswick Pike,
Lawrenceville, NJ 08648
Made in India

Code No.: TS/DRUGS/22/2009
PACKAGE LABEL-PRINCIPAL DISPLAY PANEL - 220 mg (100 Tablets, Container Label)
HealthyLiving
NDC: 58602-845-21
Naproxen Sodium
Tablets, USP
220 mg (NSAID)
- Pain reliever
- Fever reducer
STRENGTH TO LAST K
12 HOURS 100 Tablets
PACKAGE LABEL-PRINCIPAL DISPLAY PANEL - 220 mg (100 Tablets Carton Label)
HealthyLiving

NDC: 58602-845-21
**Compare to Aleve®

active ingredient

Naproxen Sodium Tablets, USP
220 mg (NSAID)
- Pain reliever
- Fever reducer
K
STRENGTH TO LAST 12 HOURS 100 Tablets

INGREDIENTS AND APPEARANCE

NAPROXEN SODIUM
naproxen sodium tablet, film coated

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 58602-845
Route of Administration	ORAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
NAPROXEN SODIUM (UNII: 9TN87S3A3C) (NAPROXEN - UNII:57Y76R9ATQ)	NAPROXEN SODIUM	220 mg

Ingredient Name	Strength
Inactive Ingredients
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
FD&C BLUE NO. 2 (UNII: L06K8R7DQK)
HYPROMELLOSE 2910 (5 MPA.S) (UNII: R75537T0T4)
MAGNESIUM STEARATE (UNII: 70097M6I30)
MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U)
POLYETHYLENE GLYCOL 8000 (UNII: Q662QK8M3B)
POVIDONE K30 (UNII: U725QWY32X)
TALC (UNII: 7SEV7J4R1U)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)

Product Characteristics
Color	BLUE (light blue)	Score	no score
Shape	OVAL	Size	12mm
Flavor		Imprint Code	K;45
Contains

#	Item Code	Package Description	Marketing Start Date
Packaging
1	NDC: 58602-845-21	1 in 1 CARTON	05/16/2020
1		100 in 1 BOTTLE; Type 0: Not a Combination Product

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
ANDA	ANDA205497	05/16/2020

Labeler - Aurohealth LLC (078728447)

Name	Address	ID/FEI	Business Operations
Establishment
Aurobindo Pharma Limited		650381903	ANALYSIS(58602-845) , MANUFACTURE(58602-845)

NAPROXEN SODIUM tablet, film coated

Naproxen Sodium by

Drug Labeling and Warnings

Drug Details [pdf]