Label: NAPROXEN SODIUM- naproxen sodium tablet, coated tablet
NAPROXEN SODIUM- naproxen sodium, coated tablets tablet
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NDC Code(s):
25000-141-02,
25000-141-14,
25000-141-26,
25000-141-30, view more25000-141-43, 25000-141-98, 25000-144-02, 25000-144-14, 25000-144-20, 25000-144-30, 25000-144-43, 25000-144-98
- Packager: MARKSANS PHARMA LIMITED
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: Abbreviated New Drug Application
Drug Label Information
Updated June 9, 2023
If you are a consumer or patient please visit this version.
- Download DRUG LABEL INFO: PDF XML
- Official Label (Printer Friendly)
- Active ingredient(s)
- 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 directedHeart 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.
- Do not use
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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 you are
- When using this product
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Stop use and ask 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 - If pregnant or breast-feeding,
- Keep out of reach of children
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Directions
For Tablets:
• 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- to 12-hour period
• do not exceed 3 tablets in a 24-hour periodChildren under 12 years • ask a doctor
For Caplets:
• 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 periodChildren under 12 years • ask a doctor - Other information
- Inactive ingredients
- Questions or comments?
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Principal Display Panel
NDC 25000-141-43
Naproxen Sodium Tablets, USP 220 mg
10’s count bottle label
NDC 25000-141-43
Naproxen Sodium Tablets, USP 220 mg
10’s count carton label
NDC 25000-141-02
Naproxen Sodium Tablets, USP 220 mg
24’s count bottle label
NDC 25000-141-02
Naproxen Sodium Tablets, USP 220 mg
24’s count carton label
NDC 25000-141-14
Naproxen Sodium Tablets, USP 220 mg
1000’s count bottle label
NDC 25000-144-14
Naproxen Sodium Tablets, USP 220 mg (Capsule-shaped tablet)
1000’s count bottle label
NDC 25000-144-43
Naproxen Sodium Tablets, USP 220 mg (Capsule-shaped tablet)
10’s count bottle label
NDC 25000-144-43
Naproxen Sodium Tablets, USP 220 mg (Capsule-shaped tablet)
10’s count carton label
NDC 25000-144-02
Naproxen Sodium Tablets, USP 220 mg (Capsule-shaped tablet)
24’s count bottle label
NDC 25000-144-02
Naproxen Sodium Tablets, USP 220 mg (Capsule-shaped tablet)
24’s count carton label
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INGREDIENTS AND APPEARANCE
NAPROXEN SODIUM
naproxen sodium tablet, coated tabletProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:25000-144 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 SILICON DIOXIDE (UNII: ETJ7Z6XBU4) CROSCARMELLOSE SODIUM (UNII: M28OL1HH48) FD&C BLUE NO. 2 (UNII: L06K8R7DQK) HYPROMELLOSES (UNII: 3NXW29V3WO) MAGNESIUM STEARATE (UNII: 70097M6I30) CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U) POLYETHYLENE GLYCOL (UNII: 3WJQ0SDW1A) POVIDONE (UNII: FZ989GH94E) TITANIUM DIOXIDE (UNII: 15FIX9V2JP) Product Characteristics Color BLUE Score no score Shape OVAL Size 12mm Flavor Imprint Code 144 Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:25000-144-14 1000 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product 05/04/2011 2 NDC:25000-144-20 4 in 1 BOX 05/04/2011 2 6500 in 1 BAG; Type 0: Not a Combination Product 3 NDC:25000-144-30 6 in 1 BOX 05/04/2011 3 6500 in 1 BAG; Type 0: Not a Combination Product 4 NDC:25000-144-02 160 in 1 BOX 05/04/2011 4 1 in 1 CARTON 4 24 in 1 BOTTLE; Type 0: Not a Combination Product 5 NDC:25000-144-43 10 in 1 BOTTLE; Type 0: Not a Combination Product 05/04/2011 6 NDC:25000-144-98 1 in 1 BOX 05/04/2011 6 32165 in 1 BAG; Type 0: Not a Combination Product Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date ANDA ANDA090545 05/04/2011 NAPROXEN SODIUM
naproxen sodium, coated tablets tabletProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:25000-141 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 SILICON DIOXIDE (UNII: ETJ7Z6XBU4) CROSCARMELLOSE SODIUM (UNII: M28OL1HH48) FD&C BLUE NO. 2 (UNII: L06K8R7DQK) CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U) POLYETHYLENE GLYCOL (UNII: 3WJQ0SDW1A) POVIDONE (UNII: FZ989GH94E) TITANIUM DIOXIDE (UNII: 15FIX9V2JP) HYPROMELLOSES (UNII: 3NXW29V3WO) MAGNESIUM STEARATE (UNII: 70097M6I30) Product Characteristics Color BLUE Score no score Shape ROUND Size 10mm Flavor Imprint Code 141 Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:25000-141-14 1000 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product 05/28/2011 2 NDC:25000-141-26 2 in 1 BOX 05/28/2011 2 1600 in 1 BAG; Type 0: Not a Combination Product 3 NDC:25000-141-30 6 in 1 BOX 05/28/2011 3 6500 in 1 BAG; Type 0: Not a Combination Product 4 NDC:25000-141-02 160 in 1 BOX 05/28/2011 4 1 in 1 CARTON 4 24 in 1 BOTTLE; Type 0: Not a Combination Product 5 NDC:25000-141-43 10 in 1 BOTTLE; Type 0: Not a Combination Product 05/28/2011 6 NDC:25000-141-98 1 in 1 BOX 05/28/2011 6 32165 in 1 BAG; Type 0: Not a Combination Product Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date ANDA ANDA090545 05/28/2011 Labeler - MARKSANS PHARMA LIMITED (925822975) Establishment Name Address ID/FEI Business Operations MARKSANS PHARMA LIMITED 925822975 MANUFACTURE(25000-141, 25000-144)