NAPROXEN SODIUM 220MG tablet, film coated

Naproxen Sodium 220mg by

Drug Labeling and Warnings

Naproxen Sodium 220mg by is a Otc medication manufactured, distributed, or labeled by Grocery Outlet. 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

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 you

• 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

If pregnant or 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.

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

Inactive ingredients

corn starch, FD&C blue #2 aluminum lake, hypromellose, microcrystalline
cellulose, polyethylene glycol, povidone, purified
water, sodium starch glycolate, stearic acid, titanium
dioxide

Questions/Comments

Call 1-877-290-4008

Principal Display Panel

Label

Carton

INGREDIENTS AND APPEARANCE

NAPROXEN SODIUM 220MG 
naproxen sodium 220mg tablet, film coated

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 85828-394
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)
HYPROMELLOSE, UNSPECIFIED (UNII: 3NXW29V3WO)
MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U)
POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A)
POVIDONE (UNII: FZ989GH94E)
WATER (UNII: 059QF0KO0R)
SODIUM STARCH GLYCOLATE TYPE A CORN (UNII: AG9B65PV6B)
STEARIC ACID (UNII: 4ELV7Z65AP)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)

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: 85828-394-92	1 in 1 CARTON	03/18/2026
1		90 in 1 BOTTLE; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
ANDA	ANDA090545	03/18/2026

Labeler - Grocery Outlet (029161585)