NAPROXEN SODIUM 220MG tablet, coated

Naproxen Sodium 220mg by

Drug Labeling and Warnings

Naproxen Sodium 220mg by is a Otc medication manufactured, distributed, or labeled by Allegiant Health. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Active ingredient(s)

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

*nonsteroidal anti-inflammatory drug

Purpose

Pain reliever/fever reducer

Use(s)

temporarily relieves minor aches and pains due to:

• headache
• minor pain of arthritis
• muscular aches
• backache
• menstrual cramps
• toothache
• the common cold
• temporarily reduces fever
  

Warnings

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

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 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

Pregnancy/Breastfeeding

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

Other 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

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 to 12 hour
  period
• do not exceed 3 caplets in a 24 hour period
  

Children under 12 years: 

• ask a doctor

Other information

• each caplet contains: sodium 20 mg
  
• do not use if tamper evident seal under bottle is broken or missing
  

Storage

• store at 20° to 25°C (68° to 77°F). Avoid high humidity and excessive heat above 40°C (104°F).

Inactive ingredients

Inactive ingredients FD&C blue #2 aluminum
lake, hypromellose, microcrystalline cellulose,
polyethylene glycol, povidone, titanium dioxide
May contain: corn starch, croscarmellose sodium,
magnesium stearate, purified water, silicon

Questions

Call 1-888-952-0050 Monday through Friday 9AM- 5PM EST.

Principal Display Panel

Naproxen

INGREDIENTS AND APPEARANCE

NAPROXEN SODIUM 220MG 
naproxen sodium 220mg tablet, coated

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 69168-395
Route of Administration	ORAL

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

Inactive Ingredients
Ingredient Name	Strength
STARCH, CORN (UNII: O8232NY3SJ)
FD&C BLUE NO. 2--ALUMINUM LAKE (UNII: 4AQJ3LG584)
HYPROMELLOSES (UNII: 3NXW29V3WO)
MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U)
POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A)
POVIDONE (UNII: FZ989GH94E)
WATER (UNII: 059QF0KO0R)
STEARIC ACID (UNII: 4ELV7Z65AP)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)
CROSCARMELLOSE SODIUM (UNII: M28OL1HH48)
MAGNESIUM STEARATE (UNII: 70097M6I30)
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
SODIUM STARCH GLYCOLATE TYPE B (UNII: SP4S77AHO6)

Product Characteristics
Color	blue	Score	no score
Shape	OVAL	Size	12mm
Flavor		Imprint Code	220
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 69168-395-17	300 in 1 BOTTLE; Type 0: Not a Combination Product	04/21/2021
2	NDC: 69168-395-50	50 in 1 BOTTLE; Type 0: Not a Combination Product	05/18/2022
3	NDC: 69168-395-07	10 in 1 BOTTLE; Type 0: Not a Combination Product	05/04/2011

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
ANDA	ANDA090545	05/04/2011

Labeler - Allegiant Health (079501930)