Label: PROXEN NP 660- naproxen sodium tablet
- NDC Code(s): 69729-123-12, 69729-123-24, 69729-123-50
- Packager: OPMX LLC
- Category: HUMAN OTC DRUG LABEL
Drug Label Information
Updated December 27, 2023
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- SPL UNCLASSIFIED SECTION
- ACTIVE INGREDIENT
- 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 ■ asthma (wheezing) ■ skin reddening
■ facial swelling ■ shock ■ 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 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
■ 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
■ 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 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 to12 hour period
■ do not exceed 3 tablets in a 24 hour period
Children under 12 years
■ ask a doctor
- Other information
- Inactive ingredients
- Questions or comments?
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- PRINCIPAL DISPLAY PANEL 100 CAPLETS
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INGREDIENTS AND APPEARANCE
PROXEN NP 660
naproxen sodium tabletProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:69729-123 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 HYPROMELLOSE, UNSPECIFIED (UNII: 3NXW29V3WO) FD&C BLUE NO. 2 ALUMINUM LAKE (UNII: 4AQJ3LG584) POVIDONE, UNSPECIFIED (UNII: FZ989GH94E) MAGNESIUM STEARATE (UNII: 70097M6I30) CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U) POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A) TITANIUM DIOXIDE (UNII: 15FIX9V2JP) SILICON DIOXIDE (UNII: ETJ7Z6XBU4) CROSCARMELLOSE SODIUM (UNII: M28OL1HH48) Product Characteristics Color blue (Light Blue) Score no score Shape OVAL (Capsule-Shaped) Size 12mm Flavor Imprint Code 220 Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:69729-123-12 1 in 1 CARTON 11/07/2023 1 12 in 1 BLISTER PACK; Type 0: Not a Combination Product 2 NDC:69729-123-24 2 in 1 CARTON 11/16/2023 2 12 in 1 BLISTER PACK; Type 0: Not a Combination Product 3 NDC:69729-123-50 50 in 1 CARTON 11/07/2023 3 2 in 1 POUCH; Type 0: Not a Combination Product Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date ANDA ANDA091353 11/07/2023 Labeler - OPMX LLC (029918743) Establishment Name Address ID/FEI Business Operations Granules India Limited 860316511 manufacture(69729-123) , label(69729-123) , pack(69729-123)