Label: NAPROXEN SODIUM tablet
NAPROXEN SODIUM tablet, film coated
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NDC Code(s):
62207-327-41,
62207-327-42,
62207-327-43,
62207-327-47, view more62207-327-49, 62207-328-41, 62207-328-42, 62207-328-43, 62207-328-47, 62207-328-49, 62207-728-24, 62207-728-42, 62207-728-43, 62207-728-47, 62207-728-49, 62207-729-24, 62207-729-42, 62207-729-43, 62207-729-47, 62207-729-49, 62207-761-42, 62207-761-43, 62207-761-47, 62207-761-49, 62207-762-42, 62207-762-43, 62207-762-47, 62207-762-49
- Packager: Granules India Ltd
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: Abbreviated New Drug Application
Drug Label Information
Updated February 6, 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
- USE(S)
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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 had 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
- WHEN USING THIS PRODUCT
-
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
- PREGNANCY/BREASTFEEDING
- KEEP OUT OF REACH OF CHILDREN
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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 doseAdults 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
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INACTIVE INGREDIENT
Inactive Ingredients FD&C blue#2 aluminum lake, hypromellose 2910, maize starch, microcrystalline cellulose, polyethylene glycol, povidone k-30, sodium starch glycolate, stearic acid, titanium dioxide
Questions or Comments?
1-877-770-3183 Mon - Fri 9:00 AM to 4:30 PM ESTDo not use if carton is open or of foil seal on bottle opening is missing or broken.
Manufactured By:
Granules India Limited
Hyderabad –500 081, India
MADE IN INDIA
M.L. 37/RR/AP/2003/F/R - PRINCIPAL DISPLAY PANEL
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INGREDIENTS AND APPEARANCE
NAPROXEN SODIUM
naproxen sodium tabletProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:62207-328 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 FD&C BLUE NO. 2 (UNII: L06K8R7DQK) HYPROMELLOSES (UNII: 3NXW29V3WO) STARCH, CORN (UNII: O8232NY3SJ) CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U) POLYETHYLENE GLYCOL 400 (UNII: B697894SGQ) POVIDONE K30 (UNII: U725QWY32X) SODIUM STARCH GLYCOLATE TYPE A POTATO (UNII: 5856J3G2A2) STEARIC ACID (UNII: 4ELV7Z65AP) TITANIUM DIOXIDE (UNII: 15FIX9V2JP) Product Characteristics Color blue (Light 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:62207-328-41 24 in 1 BOTTLE; Type 0: Not a Combination Product 07/16/2021 2 NDC:62207-328-42 50 in 1 BOTTLE; Type 0: Not a Combination Product 07/16/2021 3 NDC:62207-328-43 100 in 1 BOTTLE; Type 0: Not a Combination Product 07/16/2021 4 NDC:62207-328-47 500 in 1 BOTTLE; Type 0: Not a Combination Product 07/16/2021 5 NDC:62207-328-49 1000 in 1 BOTTLE; Type 0: Not a Combination Product 07/16/2021 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date ANDA ANDA091353 07/16/2021 NAPROXEN SODIUM
naproxen sodium tabletProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:62207-327 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 FD&C BLUE NO. 2 (UNII: L06K8R7DQK) HYPROMELLOSES (UNII: 3NXW29V3WO) STARCH, CORN (UNII: O8232NY3SJ) CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U) POLYETHYLENE GLYCOL 400 (UNII: B697894SGQ) POVIDONE K30 (UNII: U725QWY32X) SODIUM STARCH GLYCOLATE TYPE A POTATO (UNII: 5856J3G2A2) STEARIC ACID (UNII: 4ELV7Z65AP) TITANIUM DIOXIDE (UNII: 15FIX9V2JP) Product Characteristics Color blue (Light Blue) Score no score Shape OVAL (Caplet -Shaped) Size 12mm Flavor Imprint Code 220 Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:62207-327-41 24 in 1 BOTTLE; Type 0: Not a Combination Product 07/16/2021 2 NDC:62207-327-42 50 in 1 BOTTLE; Type 0: Not a Combination Product 07/16/2021 3 NDC:62207-327-43 100 in 1 BOTTLE; Type 0: Not a Combination Product 07/16/2021 4 NDC:62207-327-47 500 in 1 BOTTLE; Type 0: Not a Combination Product 07/16/2021 5 NDC:62207-327-49 1000 in 1 BOTTLE; Type 0: Not a Combination Product 07/16/2021 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date ANDA ANDA091353 07/16/2021 NAPROXEN SODIUM
naproxen sodium tablet, film coatedProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:62207-761 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 FD&C BLUE NO. 2 (UNII: L06K8R7DQK) HYPROMELLOSES (UNII: 3NXW29V3WO) STARCH, CORN (UNII: O8232NY3SJ) CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U) POLYETHYLENE GLYCOL 400 (UNII: B697894SGQ) POVIDONE K30 (UNII: U725QWY32X) SODIUM STARCH GLYCOLATE TYPE A POTATO (UNII: 5856J3G2A2) STEARIC ACID (UNII: 4ELV7Z65AP) TITANIUM DIOXIDE (UNII: 15FIX9V2JP) Product Characteristics Color blue (Light Blue) Score no score Shape ROUND Size 9mm Flavor Imprint Code 220 Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:62207-761-42 50 in 1 BOTTLE; Type 0: Not a Combination Product 09/30/2011 2 NDC:62207-761-43 100 in 1 BOTTLE; Type 0: Not a Combination Product 09/30/2011 3 NDC:62207-761-47 500 in 1 BOTTLE; Type 0: Not a Combination Product 09/30/2011 4 NDC:62207-761-49 1000 in 1 BOTTLE; Type 0: Not a Combination Product 09/30/2011 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date ANDA ANDA091353 09/30/2011 NAPROXEN SODIUM
naproxen sodium tablet, film coatedProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:62207-762 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 FD&C BLUE NO. 2 (UNII: L06K8R7DQK) HYPROMELLOSES (UNII: 3NXW29V3WO) STARCH, CORN (UNII: O8232NY3SJ) CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U) POLYETHYLENE GLYCOL 400 (UNII: B697894SGQ) POVIDONE K30 (UNII: U725QWY32X) SODIUM STARCH GLYCOLATE TYPE A POTATO (UNII: 5856J3G2A2) STEARIC ACID (UNII: 4ELV7Z65AP) TITANIUM DIOXIDE (UNII: 15FIX9V2JP) Product Characteristics Color blue (Light Blue) Score no score Shape OVAL (Caplet -Shaped) Size 12mm Flavor Imprint Code 220 Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:62207-762-42 50 in 1 BOTTLE; Type 0: Not a Combination Product 09/30/2011 2 NDC:62207-762-43 100 in 1 BOTTLE; Type 0: Not a Combination Product 09/30/2011 3 NDC:62207-762-47 500 in 1 BOTTLE; Type 0: Not a Combination Product 09/30/2011 4 NDC:62207-762-49 1000 in 1 BOTTLE; Type 0: Not a Combination Product 09/30/2011 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date ANDA ANDA091353 09/30/2011 NAPROXEN SODIUM
naproxen sodium tabletProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:62207-728 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 FD&C BLUE NO. 2 (UNII: L06K8R7DQK) HYPROMELLOSES (UNII: 3NXW29V3WO) STARCH, CORN (UNII: O8232NY3SJ) CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U) POLYETHYLENE GLYCOL 400 (UNII: B697894SGQ) POVIDONE K30 (UNII: U725QWY32X) SODIUM STARCH GLYCOLATE TYPE A POTATO (UNII: 5856J3G2A2) STEARIC ACID (UNII: 4ELV7Z65AP) TITANIUM DIOXIDE (UNII: 15FIX9V2JP) Product Characteristics Color blue (Light 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:62207-728-24 24 in 1 BOTTLE; Type 0: Not a Combination Product 06/08/2018 2 NDC:62207-728-42 50 in 1 BOTTLE; Type 0: Not a Combination Product 06/08/2018 3 NDC:62207-728-43 100 in 1 BOTTLE; Type 0: Not a Combination Product 06/08/2018 4 NDC:62207-728-47 500 in 1 BOTTLE; Type 0: Not a Combination Product 06/08/2018 5 NDC:62207-728-49 1000 in 1 BOTTLE; Type 0: Not a Combination Product 06/08/2018 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date ANDA ANDA091353 06/08/2018 NAPROXEN SODIUM
naproxen sodium tabletProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:62207-729 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 FD&C BLUE NO. 2 (UNII: L06K8R7DQK) HYPROMELLOSES (UNII: 3NXW29V3WO) STARCH, CORN (UNII: O8232NY3SJ) CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U) POLYETHYLENE GLYCOL 400 (UNII: B697894SGQ) POVIDONE K30 (UNII: U725QWY32X) SODIUM STARCH GLYCOLATE TYPE A POTATO (UNII: 5856J3G2A2) STEARIC ACID (UNII: 4ELV7Z65AP) TITANIUM DIOXIDE (UNII: 15FIX9V2JP) Product Characteristics Color blue (Light Blue) Score no score Shape OVAL (Caplet -Shaped) Size 12mm Flavor Imprint Code 220 Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:62207-729-24 24 in 1 BOTTLE; Type 0: Not a Combination Product 06/08/2018 2 NDC:62207-729-42 50 in 1 BOTTLE; Type 0: Not a Combination Product 06/08/2018 3 NDC:62207-729-43 100 in 1 BOTTLE; Type 0: Not a Combination Product 06/08/2018 4 NDC:62207-729-47 500 in 1 BOTTLE; Type 0: Not a Combination Product 06/08/2018 5 NDC:62207-729-49 1000 in 1 BOTTLE; Type 0: Not a Combination Product 06/08/2018 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date ANDA ANDA091353 06/08/2018 Labeler - Granules India Ltd (915000087) Establishment Name Address ID/FEI Business Operations Granules India Ltd 918609236 manufacture(62207-728, 62207-729, 62207-761, 62207-762, 62207-327, 62207-328)