Label: NAPROXEN SODIUM CAPLETS- naproxen sodium tablet
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Contains inactivated NDC Code(s)
NDC Code(s): 70729-003-24, 70729-003-50 - Packager: Breeden Brothers, LLC
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: Abbreviated New Drug Application
Drug Label Information
Updated February 1, 2017
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- Official Label (Printer Friendly)
- SPL UNCLASSIFIED SECTION
- Active ingredient (in each caplet)
- 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:
_ asthma (wheezing) _ skin reddening _ shock
_ blisters _ rash _ facial swelling _ hives
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 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 a blood thinning (anticoagulant) or steroid drug
_ take more or for a longer time than directed
Drug Facts (continued)
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 have asthma
_ you have problems or serious side effects from taking pain relievers or fever reducers
_ you are taking a diuretic
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
_ the risk of heart attack or stroke may increase if you use more than directed or for longer than directed
Drug Facts (continued)
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
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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
- Inactive ingredients
- Questions or comments?
- PRINCIPAL DISPLAY PANEL
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INGREDIENTS AND APPEARANCE
NAPROXEN SODIUM CAPLETS
naproxen sodium tabletProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:70729-003 Route of Administration ORAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength NAPROXEN SODIUM (UNII: 9TN87S3A3C) (NAPROXEN - UNII:57Y76R9ATQ) NAPROXEN 220 mg Inactive Ingredients Ingredient Name Strength CROSCARMELLOSE SODIUM (UNII: M28OL1HH48) FD&C BLUE NO. 2 (UNII: L06K8R7DQK) MAGNESIUM STEARATE (UNII: 70097M6I30) CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U) POLYETHYLENE GLYCOLS (UNII: 3WJQ0SDW1A) POLYVINYL ALCOHOL, UNSPECIFIED (UNII: 532B59J990) POVIDONE (UNII: FZ989GH94E) SILICON DIOXIDE (UNII: ETJ7Z6XBU4) TALC (UNII: 7SEV7J4R1U) TITANIUM DIOXIDE (UNII: 15FIX9V2JP) Product Characteristics Color BLUE Score no score Shape OVAL Size 12mm Flavor Imprint Code 44;604 Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:70729-003-24 24 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product 02/01/2017 2 NDC:70729-003-50 50 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product 02/01/2017 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date ANDA ANDA204872 02/01/2017 Labeler - Breeden Brothers, LLC (080131046)
