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NDC 27854-0700-10 Flanax Pain Reliever/Fever Reducer 220 mg/1 Details
Flanax Pain Reliever/Fever Reducer 220 mg/1
Flanax Pain Reliever/Fever Reducer is a ORAL TABLET, FILM COATED in the HUMAN OTC DRUG category. It is labeled and distributed by Belmora LLC. 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: 27854-0700-10Last Updated: 11/30/2022
MedLinePlus Full Drug Details: Naproxen
Product Information
NDC | 27854-0700 |
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Product ID | 27854-700_4215c852-11ed-4b06-b132-3674265078e3 |
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 | Flanax Pain Reliever/Fever Reducer |
Proprietary Name Suffix | n/a |
Non-Proprietary Name | Naproxen sodium |
Product Type | HUMAN OTC DRUG |
Dosage Form | TABLET, FILM COATED |
Route | ORAL |
Active Ingredient Strength | 220 |
Active Ingredient Units | mg/1 |
Substance Name | NAPROXEN SODIUM |
Labeler Name | Belmora LLC |
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 | ANDA205497 |
Listing Certified Through | 2024-12-31 |
Package
Package Images

NDC 27854-0700-10 (27854070010)
NDC Package Code | 27854-700-10 |
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Billing NDC | 27854070010 |
Package | 1 BOTTLE in 1 CARTON (27854-700-10) / 10 TABLET, FILM COATED in 1 BOTTLE |
Marketing Start Date | 2020-05-15 |
NDC Exclude Flag | N |
Pricing Information | N/A |
Standard Product Labeling (SPL)/Prescribing Information SPL a93e4966-9dd3-40ba-b7d6-6ca8fef229c6 Details
Active ingredient (in each tablet)
SPL UNCLASSIFIED SECTION
Warnings
Allergy alert: Naproxen sodium may cause a severe allergic reaction, especially in people allergic to aspirin. Symptoms may include: ■ shock ■ facial swelling ■ asthma (wheezing) ■ hives ■ skin reddening ■ blisters ■ rash
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
■ have had stomach ulcers or bleeding problems
■ take blood thinning (anticoagulant) or steroid drug
■ are age 60 or older
■ take other drugs containing prescription or nonprescription NSAIDs [aspirin, ibuprofen, naproxen, or others]
■ take more or for a longer time than directed
■ have 3 or more alcoholic drinks every day while using this product.
Heart attack and stroke warning: NSAIDs, except aspirin, increases 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 are taking a diuretic
■ you have high blood pressure, heart disease, liver cirrhosis, kidney disease, asthma, or had a stroke
■ you have a problems or serious side effects from taking pain relievers or fever reducers
Ask a doctor or pharmacist before use if you are
■ under a doctor's care for any serious condition
■ taking any other drug
When using this product
■ take with food or milk if stomach upset occurs
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: ■ leg swelling ■ chest pain ■ slurred speech ■ 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
■ 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, ask a health professional before use. It is especially important not to use naproxen sodium during the last 3 months of pregnancy unless definitely directed to do so by a doctor because it may cause problems in the unborn child or complications during delivery.
SPL UNCLASSIFIED SECTION
Directions ■ 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 to12 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
SPL UNCLASSIFIED SECTION
SPL UNCLASSIFIED SECTION
INGREDIENTS AND APPEARANCE
FLANAX PAIN RELIEVER/FEVER REDUCER
naproxen sodium tablet, film coated |
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Labeler - Belmora LLC (112753244) |