Label: NAPROXEN SODIUM tablet
-
NDC Code(s):
62207-750-41,
62207-750-42,
62207-750-43,
62207-750-44, view more62207-750-45, 62207-750-47, 62207-750-49, 62207-750-51, 62207-750-52, 62207-750-53, 62207-753-41, 62207-753-42, 62207-753-43, 62207-753-44, 62207-753-45, 62207-753-47, 62207-753-49, 62207-753-51, 62207-753-52, 62207-753-53
- Packager: Granules India Limited
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: Abbreviated New Drug Application
Drug Label Information
Updated December 11, 2023
If you are a consumer or patient please visit this version.
- Download DRUG LABEL INFO: PDF XML
- Official Label (Printer Friendly)
- ACTIVE INGREDIENT
- PURPOSE
- INDICATIONS AND USAGE
-
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 directed
- DO NOT USE
-
ASK DOCTOR
- 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 DOCTOR/PHARMACIST
- WHEN USING
-
STOP USE
- 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
- you develop heartburn
- redness or swelling is present in the painful area
- any new symptoms appear
- PREGNANCY OR BREAST FEEDING
- KEEP OUT OF REACH OF CHILDREN
-
DOSAGE AND ADMINISTRATION
- 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 - INACTIVE INGREDIENT
- QUESTIONS
- PACKAGE LABEL.PRINCIPAL DISPLAY PANEL
-
INGREDIENTS AND APPEARANCE
NAPROXEN SODIUM
naproxen sodium tabletProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:62207-750 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 CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U) STARCH, CORN (UNII: O8232NY3SJ) POVIDONE K30 (UNII: U725QWY32X) SODIUM STARCH GLYCOLATE TYPE A POTATO (UNII: 5856J3G2A2) STEARIC ACID (UNII: 4ELV7Z65AP) HYPROMELLOSES (UNII: 3NXW29V3WO) POLYETHYLENE GLYCOL 400 (UNII: B697894SGQ) TITANIUM DIOXIDE (UNII: 15FIX9V2JP) FD&C BLUE NO. 2 (UNII: L06K8R7DQK) Product Characteristics Color blue (Light Blue) Score no score Shape ROUND Size 10mm Flavor Imprint Code I1 Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:62207-750-41 24 in 1 BOTTLE; Type 0: Not a Combination Product 09/30/2011 2 NDC:62207-750-42 50 in 1 BOTTLE; Type 0: Not a Combination Product 09/30/2011 3 NDC:62207-750-43 43 in 1 BOTTLE; Type 0: Not a Combination Product 09/30/2011 4 NDC:62207-750-44 150 in 1 BOTTLE; Type 0: Not a Combination Product 09/30/2011 5 NDC:62207-750-45 200 in 1 BOTTLE; Type 0: Not a Combination Product 09/30/2011 6 NDC:62207-750-47 500 in 1 BOTTLE; Type 0: Not a Combination Product 09/30/2011 7 NDC:62207-750-49 1000 in 1 BOTTLE; Type 0: Not a Combination Product 09/30/2011 8 NDC:62207-750-51 10 in 1 BOTTLE; Type 0: Not a Combination Product 09/30/2011 9 NDC:62207-750-52 300 in 1 BOTTLE; Type 0: Not a Combination Product 09/30/2011 10 NDC:62207-750-53 400 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:62207-753 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 CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U) STARCH, CORN (UNII: O8232NY3SJ) POVIDONE K30 (UNII: U725QWY32X) SODIUM STARCH GLYCOLATE TYPE A POTATO (UNII: 5856J3G2A2) STEARIC ACID (UNII: 4ELV7Z65AP) HYPROMELLOSES (UNII: 3NXW29V3WO) POLYETHYLENE GLYCOL 400 (UNII: B697894SGQ) TITANIUM DIOXIDE (UNII: 15FIX9V2JP) FD&C BLUE NO. 2 (UNII: L06K8R7DQK) 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:62207-753-41 24 in 1 BOTTLE; Type 0: Not a Combination Product 09/30/2011 2 NDC:62207-753-42 50 in 1 BOTTLE; Type 0: Not a Combination Product 09/30/2011 3 NDC:62207-753-43 43 in 1 BOTTLE; Type 0: Not a Combination Product 09/30/2011 4 NDC:62207-753-44 150 in 1 BOTTLE; Type 0: Not a Combination Product 09/30/2011 5 NDC:62207-753-45 200 in 1 BOTTLE; Type 0: Not a Combination Product 09/30/2011 6 NDC:62207-753-47 500 in 1 BOTTLE; Type 0: Not a Combination Product 09/30/2011 7 NDC:62207-753-49 1000 in 1 BOTTLE; Type 0: Not a Combination Product 09/30/2011 8 NDC:62207-753-51 10 in 1 BOTTLE; Type 0: Not a Combination Product 09/30/2011 9 NDC:62207-753-52 300 in 1 BOTTLE; Type 0: Not a Combination Product 09/30/2011 10 NDC:62207-753-53 400 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 Labeler - Granules India Limited (915000087) Establishment Name Address ID/FEI Business Operations Granules India Limited 918609236 analysis(62207-750, 62207-753) , manufacture(62207-750, 62207-753) , pack(62207-750, 62207-753) , label(62207-750, 62207-753)