Label: NAPROXEN SODIUM 220MG tablet, coated
- NDC Code(s): 53185-362-50
- Packager: Athlete's Needs, Inc.
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: Abbreviated New Drug Application
Drug Label Information
Updated November 14, 2017
If you are a consumer or patient please visit this version.
- Download DRUG LABEL INFO: PDF XML
- Official Label (Printer Friendly)
- Active ingredient
- Purpose
- Uses
-
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.
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, or kidney disease
- you are taking a diuretic
- you have problems or serious side effects from taking pain relievers or fever reducers
- you have asthma
Ask a doctor or pharmacist before use if you are
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
- the risk of heart attack or stroke may increase if you use more than directed or for longer than directed
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
- 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
- You may report side effects to 1-888-952-0050
If pregnant or breast-feeding,
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.
-
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
- Inactive ingredients
- Questions or Comments?
- Principal Display Panel
-
INGREDIENTS AND APPEARANCE
NAPROXEN SODIUM 220MG
naproxen sodium 220mg tablet, coatedProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:53185-362 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 CROSCARMELLOSE SODIUM (UNII: M28OL1HH48) FD&C BLUE NO. 2 (UNII: L06K8R7DQK) HYPROMELLOSES (UNII: 3NXW29V3WO) MAGNESIUM STEARATE (UNII: 70097M6I30) MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U) POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A) POVIDONE (UNII: FZ989GH94E) SILICON DIOXIDE (UNII: ETJ7Z6XBU4) Product Characteristics Color blue Score no score Shape OVAL Size 10mm Flavor Imprint Code 144 Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:53185-362-50 50 in 1 BOTTLE; Type 0: Not a Combination Product 12/23/2014 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date ANDA ANDA090545 12/23/2014 Labeler - Athlete's Needs, Inc. (619703945)
