Label: NAPROXEN SODIUM tablet
- NDC Code(s): 69848-009-01, 69848-010-01, 69848-010-05, 69848-010-10
- Packager: Granules USA, Inc.
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: Abbreviated New Drug Application
Drug Label Information
Updated January 2, 2024
If you are a consumer or patient please visit this version.
- Download DRUG LABEL INFO: PDF XML
- Official Label (Printer Friendly)
- Active ingredient (For Tablet)
- Active ingredient (For Caplet)
- Purposes
- Uses
- Allergy alert:
-
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
- Heart attack and stroke warning:
- Do not use
-
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
-
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
■ 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 the reach of children.
-
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 period
Children under 12 years
■ ask a doctor
-
Directions (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 period
Children under 12 years
■ ask a doctor
- Other information (For Tablet)
- Other information (For Caplet)
- Inactive ingredients
- Questions or comments?
- Tablets
- Caplets
-
INGREDIENTS AND APPEARANCE
NAPROXEN SODIUM
naproxen sodium tabletProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:69848-010 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 MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U) FD&C BLUE NO. 2 (UNII: L06K8R7DQK) HYPROMELLOSES (UNII: 3NXW29V3WO) STARCH, CORN (UNII: O8232NY3SJ) STEARIC ACID (UNII: 4ELV7Z65AP) POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A) TITANIUM DIOXIDE (UNII: 15FIX9V2JP) POVIDONE (UNII: FZ989GH94E) SODIUM STARCH GLYCOLATE TYPE A POTATO (UNII: 5856J3G2A2) Product Characteristics Color blue Score no score Shape ROUND Size 10mm Flavor Imprint Code 220 Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:69848-010-01 10 in 1 BOTTLE; Type 0: Not a Combination Product 07/01/2019 2 NDC:69848-010-05 50 in 1 BOTTLE; Type 0: Not a Combination Product 03/01/2023 3 NDC:69848-010-10 100 in 1 BOTTLE; Type 0: Not a Combination Product 03/01/2023 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date ANDA ANDA091353 07/01/2019 NAPROXEN SODIUM
naproxen sodium tabletProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:69848-009 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 MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U) TITANIUM DIOXIDE (UNII: 15FIX9V2JP) STEARIC ACID (UNII: 4ELV7Z65AP) POVIDONE (UNII: FZ989GH94E) SODIUM STARCH GLYCOLATE TYPE A POTATO (UNII: 5856J3G2A2) FD&C BLUE NO. 2 (UNII: L06K8R7DQK) HYPROMELLOSES (UNII: 3NXW29V3WO) STARCH, CORN (UNII: O8232NY3SJ) POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A) Product Characteristics Color blue Score no score Shape OVAL Size 12mm Flavor Imprint Code 220 Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:69848-009-01 10 in 1 BOTTLE; Type 0: Not a Combination Product 07/01/2019 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date ANDA ANDA091353 07/01/2019 12/31/2023 Labeler - Granules USA, Inc. (137098864)