Label: NAPROXEN SODIUM 220MG tablet, coated
- NDC Code(s): 69168-395-07, 69168-395-17, 69168-395-50
- Packager: Allegiant Health
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: Abbreviated New Drug Application
Drug Label Information
Updated April 21, 2021
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- Official Label (Printer Friendly)
- Active ingredient(s)
- Purpose
- Use(s)
-
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
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
- if you have ever had an allergic reaction to
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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
- Storage
- Inactive ingredients
- Questions
- Principal Display Panel
-
INGREDIENTS AND APPEARANCE
NAPROXEN SODIUM 220MG
naproxen sodium 220mg tablet, coatedProduct 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)