Label: NAPROXEN- naproxen sodium tablet, coated
- NDC Code(s): 53943-144-02, 53943-144-03
- Packager: DISCOUNT DRUG MART
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: Abbreviated New Drug Application
Drug Label Information
Updated November 30, 2021
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- Official Label (Printer Friendly)
- SPL UNCLASSIFIED SECTION
- Active ingredient (in each tablet)
- Purpose
- Uses
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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
- 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 asthma
- 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
- long term continuous use may increase the risk of heart attack or stroke
Stop use and ask a doctor if
- side effects occur. You may report side effects to FDA at 1-800-FDA-1088.
- 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
- you develop heartburn
- redness or swelling is present in the painful area
- any new symptoms appear
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Directions
- do not take more than directed
- the smallest effective dose should be used
- do not take longer than 10 days, unless directed by a doctor (see Warnings)
- 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
- Inactive ingredients
- PRINCIPAL DISPLAY PANEL
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INGREDIENTS AND APPEARANCE
NAPROXEN
naproxen sodium tablet, coatedProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:53943-144 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) POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A) MAGNESIUM STEARATE (UNII: 70097M6I30) POLYVINYL ALCOHOL (UNII: 532B59J990) POVIDONE, UNSPECIFIED (UNII: FZ989GH94E) STARCH, CORN (UNII: O8232NY3SJ) TALC (UNII: 7SEV7J4R1U) TITANIUM DIOXIDE (UNII: 15FIX9V2JP) Product Characteristics Color blue Score no score Shape ROUND Size 10mm Flavor Imprint Code I3 Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:53943-144-02 1 in 1 CARTON 10/28/2014 1 50 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product 2 NDC:53943-144-03 1 in 1 CARTON 10/28/2014 2 100 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date ANDA ANDA079096 10/28/2014 Labeler - DISCOUNT DRUG MART (047741335)