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NDC 49035-0075-12 Naproxen Sodium 220 mg/1 Details
Naproxen Sodium 220 mg/1
Naproxen Sodium is a ORAL CAPSULE, LIQUID FILLED in the HUMAN OTC DRUG category. It is labeled and distributed by EQUATE (Wal-Mart Stores, Inc.). The primary component is NAPROXEN SODIUM.
MedlinePlus Drug Summary
Prescription naproxen is used to relieve pain, tenderness, swelling, and stiffness caused by osteoarthritis (arthritis caused by a breakdown of the lining of the joints), rheumatoid arthritis (arthritis caused by swelling of the lining of the joints), juvenile arthritis (a form of joint disease in children), and ankylosing spondylitis (arthritis that mainly affects the spine). Prescription naproxen tablets, extended-release tablets, and suspension are also used to relieve shoulder pain caused by bursitis (inflammation of a fluid-filled sac in the shoulder joint), tendinitis (inflammation of the tissue that connects muscle to bone), gouty arthritis (attacks of joint pain caused by a build-up of certain substances in the joints), and pain from other causes, including menstrual pain (pain that happens before or during a menstrual period). Nonprescription naproxen is used to reduce fever and to relieve mild pain from headaches, muscle aches, arthritis, menstrual periods, the common cold, toothaches, and backaches. Naproxen is in a class of medications called NSAIDs. It works by stopping the body's production of a substance that causes pain, fever, and inflammation.
Related Packages: 49035-0075-12Last Updated: 11/30/2022
MedLinePlus Full Drug Details: Naproxen
Product Information
| NDC | 49035-0075 |
|---|---|
| Product ID | 49035-075_f4b7b741-58bc-4de7-b4a8-e8be46d99852 |
| Associated GPIs | 66100060100127 |
| GCN Sequence Number | 066844 |
| GCN Sequence Number Description | naproxen sodium CAPSULE 220 MG ORAL |
| HIC3 | S2B |
| HIC3 Description | NSAIDS, CYCLOOXYGENASE INHIBITOR TYPE ANALGESICS |
| GCN | 29254 |
| HICL Sequence Number | 003726 |
| HICL Sequence Number Description | NAPROXEN SODIUM |
| Brand/Generic | Generic |
| Proprietary Name | Naproxen Sodium |
| Proprietary Name Suffix | n/a |
| Non-Proprietary Name | Naproxen Sodium |
| Product Type | HUMAN OTC DRUG |
| Dosage Form | CAPSULE, LIQUID FILLED |
| Route | ORAL |
| Active Ingredient Strength | 220 |
| Active Ingredient Units | mg/1 |
| Substance Name | NAPROXEN SODIUM |
| Labeler Name | EQUATE (Wal-Mart Stores, Inc.) |
| Pharmaceutical Class | Anti-Inflammatory Agents, Non-Steroidal [CS], Cyclooxygenase Inhibitors [MoA], Nonsteroidal Anti-inflammatory Drug [EPC] |
| DEA Schedule | n/a |
| Marketing Category | NDA |
| Application Number | NDA021920 |
| Listing Certified Through | n/a |
Package
Package Images
NDC 49035-0075-12 (49035007512)
| NDC Package Code | 49035-075-12 |
|---|---|
| Billing NDC | 49035007512 |
| Package | 120 CAPSULE, LIQUID FILLED in 1 BOTTLE, PLASTIC (49035-075-12) |
| Marketing Start Date | 2014-09-30 |
| NDC Exclude Flag | N |
| Pricing Information | N/A |
Standard Product Labeling (SPL)/Prescribing Information SPL b899db63-3b9f-464b-a89b-53188d46b0cc Details
Active ingredient (in each capsule)
Uses
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
- have 3 or more alcoholic drinks every day while using this product
- take other drugs containing prescription or nonprescription NSAIDs (aspirin, ibuprofen, naproxen, or others)
- take more or for a longer time than directed
Heart attack and stroke warning: NSAIDs, except aspirin, increase the riskof 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
- 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 kidney disease, asthma, or had a stroke
- you have problems or serious side effects from taking pain relievers or fever reducer
- you are taking a diuretic
Ask a doctor or pharmacist before use if you are
- under a doctor’s care for any serious condition
- taking any other drug
Stop use and ask a doctor if
- you experience any of the following signs of stomach bleeding:
- feel faint
- have bloody or black stools
- vomit blood
- have stomach pain that does not get better
- You have symptoms of heart problems or stroke:
- chest pain
- slurred speech
- leg swelling
- trouble breathing
- weakness in one part or side of body
- pain gets worse or lasts more than 10 days
- fever gets worse or lasts more than 3 days
- redness or swelling is present in the painful area
- any new symptoms appear
- you have difficulty swallowing
- it feels like the capsule is stuck in your throat
Directions
- do not take more than directed
- the smallest effective dose should be used
- drink a full glass of water with each dose
- if taken with food, this product may take longer to work
- adults and children 12 years and older:
- take 1 capsule every 8 to 12 hours while symptoms last
- for the first dose you may take 2 capsules within the first hour
- do not exceed 2 capsules in any 8- to 12-hour period
- do not exceed 3 capsules in a 24-hour period
- children under 12 years: ask a doctor
Other information
Inactive ingredients
Principal Display Panel
Compare to Active Ingredient in Aleve®**
Naproxen sodium
Capsules, 220 mg (NSAID)
pain reliever/fever reducer
12 HOUR RELIEF
CAPSULES
†Liquid Filled Capsules
TAMPER EVIDENT: DO NOT USE IF PRINTED SAFETY SEAL UNDER CAP IS BROKEN OR MISSING.
KEEEP OUTER CARTON FOR COMPLETE WARNINGS AND PRODUCT INFORMATION
**This product is not manufactured or distributed by Bayer HealthCare, LLC, distributor of Aleve®.
Distributed by: Wal-Mart Stores, Inc.,
Bentonville, AR 72716
PRODUCT OF INDIA
INGREDIENTS AND APPEARANCE
| NAPROXEN SODIUM
naproxen sodium capsule, liquid filled |
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| Labeler - EQUATE (Wal-Mart Stores, Inc.) (051957769) |