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NDC 00363-7510-20 Naproxen Sodium 220 mg/1 Details
Naproxen Sodium 220 mg/1
Naproxen Sodium is a ORAL TABLET in the HUMAN OTC DRUG category. It is labeled and distributed by Walgreens. The primary component is NAPROXEN SODIUM.
Product Information
| NDC | 00363-7510 |
|---|---|
| Product ID | 0363-7510_e5a5fe51-e1a2-4103-b1f5-2a2d33e79307 |
| Associated GPIs | |
| GCN Sequence Number | n/a |
| GCN Sequence Number Description | n/a |
| HIC3 | n/a |
| HIC3 Description | n/a |
| GCN | n/a |
| HICL Sequence Number | n/a |
| HICL Sequence Number Description | n/a |
| Brand/Generic | n/a |
| Proprietary Name | Naproxen Sodium |
| Proprietary Name Suffix | n/a |
| Non-Proprietary Name | Naproxen Sodium |
| Product Type | HUMAN OTC DRUG |
| Dosage Form | TABLET |
| Route | ORAL |
| Active Ingredient Strength | 220 |
| Active Ingredient Units | mg/1 |
| Substance Name | NAPROXEN SODIUM |
| Labeler Name | Walgreens |
| Pharmaceutical Class | Anti-Inflammatory Agents, Non-Steroidal [CS], Cyclooxygenase Inhibitors [MoA], Nonsteroidal Anti-inflammatory Drug [EPC] |
| DEA Schedule | n/a |
| Marketing Category | ANDA |
| Application Number | ANDA202807 |
| Listing Certified Through | 2024-12-31 |
Package
Package Images
NDC 00363-7510-20 (00363751020)
| NDC Package Code | 0363-7510-20 |
|---|---|
| Billing NDC | 00363751020 |
| Package | 1 BOTTLE, PLASTIC in 1 BOX (0363-7510-20) / 20 TABLET in 1 BOTTLE, PLASTIC |
| Marketing Start Date | 2020-01-31 |
| NDC Exclude Flag | N |
| Pricing Information | N/A |
Standard Product Labeling (SPL)/Prescribing Information SPL a380cace-43dc-4b9c-84d3-0b38241d9d2e 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 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
- 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 reducers
- 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 aspirin for heart attack or stroke, because naproxen may decrease this benefit of aspirin
- 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 problem 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
- 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 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
- each tablet contains: sodium 20 mg
- store at 20º to 25°C (68º to 77°F). excursions permitted between 15ºC and 30ºC (59ºF to 86ºF)[See USP Controlled Room Temperature]. Avoid high humidity and excessive heat above 40°C (104°F). Protect from Light.
- read all directions and warnings before use. Keep carton.
- swallow whole: do not crush, chew or dissolve
Inactive ingredients
Principal Display Panel
Compare to the active ingredient in Aleve® Liquid Gels††
All Day Pain Relief
NAPROXEN SODIUM
CAPSULES, 220 mg (NSAID) /
PAIN RELIEVER / FEVER REDUCER
12 HOUR
LIQUID GELS**
(**Liquid-filled capsules)
††This product is not manufactured or distributed by Bayer Healthcare, LLC, distributor of Aleve® Liquid Gels.
TAMPER EVIDENT: DO NOT USE IF PRINTED SAFETY SEAL UNDER CAP IS BROKEN OR MISSING
KEEP OUTER CARTON FOR COMPLETE WARNINGS AND PRODUCT INFORMATION
DISTRIBUTED BY: WALGREEN CO.
200 WILMOT RD., DEERFIELD, IL 60015
INGREDIENTS AND APPEARANCE
| NAPROXEN SODIUM
naproxen sodium tablet |
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| Labeler - Walgreens (008965063) |
Revised: 3/2022
Document Id: e5a5fe51-e1a2-4103-b1f5-2a2d33e79307
Set id: a380cace-43dc-4b9c-84d3-0b38241d9d2e
Version: 2
Effective Time: 20220330