Flanax®

Flanax®
SPL v1
SPL
SPL Set ID a93e4966-9dd3-40ba-b7d6-6ca8fef229c6
Route
ORAL
Published
Effective Date 2020-05-20
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Naproxen (220 mg)
Inactive Ingredients
Silicon Dioxide Fd&c Blue No. 2 Hypromellose 2910 (5 Mpa.s) Magnesium Stearate Microcrystalline Cellulose Polyethylene Glycol 8000 Povidone K30 Titanium Dioxide Talc

Identifiers & Packaging

Marketing Status
ANDA Active Since 2020-05-15

Description

Naproxen sodium 220 mg (naproxen 200 mg) (NSAID)* *nonsteroidal anti-inflammatory drug

Purpose

Pain reliever/ fever reducer


Medication Information

Indications and Usage

Uses ■ temporarily relieves minor aches and pain due to: ■ headache ■ muscular aches ■ toothache ■ the common cold ■ backache ■ menstrual cramps ■ minor pain of arthritis

■ temporarily reduces fever

Purpose

Pain reliever/ fever reducer

Dosage and Administration

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

Description

Naproxen sodium 220 mg (naproxen 200 mg) (NSAID)* *nonsteroidal anti-inflammatory drug

Section 42229-5

Longer Lasting Pain Relief

12 HOURS of pain relief

KEEP OUTER PACKAGE FOR COMPLETE PRODUCT INFORMATION

Distributed by Belmora LLC, 2011 Crystal Dr.#400 Arlington, VA 22202      

www.flanaxusa.com      

Made in India

TAMPER EVIDENT: DO NOT USE IF IMPRINTED SAFETY SEAL UNDER CAP IS BROKEN OR MISSING

Section 50565-1

Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center right away.

Section 51727-6

Inactive ingredients colloidal silicon dioxide, FD & C Blue#2 Aluminum Lake, hypromellose, magnesium stearate, microcrystalline cellulose, polyethylene glycol, povidone, titanium dioxide, talc

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.

Packaging

Drug Facts

Other Information

each tablet contains: sodium 20 mg

■ store at 20°-25°C (68°-77°F). Avoid high humidity and excessive heat above 40°C (104°F)

■ see end flap for expiration date and lot number

Questions Or Comments?

Call 1-888-779-2877 M-F 9AM-5PM EST

Active Ingredient (in Each Tablet)

Naproxen sodium 220 mg (naproxen 200 mg) (NSAID)*

*nonsteroidal anti-inflammatory drug


Structured Label Content

Indications and Usage (34067-9)

Uses ■ temporarily relieves minor aches and pain due to: ■ headache ■ muscular aches ■ toothache ■ the common cold ■ backache ■ menstrual cramps ■ minor pain of arthritis

■ temporarily reduces fever

Dosage and Administration (34068-7)

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

Section 42229-5 (42229-5)

Longer Lasting Pain Relief

12 HOURS of pain relief

KEEP OUTER PACKAGE FOR COMPLETE PRODUCT INFORMATION

Distributed by Belmora LLC, 2011 Crystal Dr.#400 Arlington, VA 22202      

www.flanaxusa.com      

Made in India

TAMPER EVIDENT: DO NOT USE IF IMPRINTED SAFETY SEAL UNDER CAP IS BROKEN OR MISSING

Section 50565-1 (50565-1)

Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center right away.

Section 51727-6 (51727-6)

Inactive ingredients colloidal silicon dioxide, FD & C Blue#2 Aluminum Lake, hypromellose, magnesium stearate, microcrystalline cellulose, polyethylene glycol, povidone, titanium dioxide, talc

Purpose

Pain reliever/ fever reducer

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.

Packaging

Drug Facts

Other Information (Other information)

each tablet contains: sodium 20 mg

■ store at 20°-25°C (68°-77°F). Avoid high humidity and excessive heat above 40°C (104°F)

■ see end flap for expiration date and lot number

Questions Or Comments? (Questions or comments?)

Call 1-888-779-2877 M-F 9AM-5PM EST

Active Ingredient (in Each Tablet) (Active ingredient (in each tablet))

Naproxen sodium 220 mg (naproxen 200 mg) (NSAID)*

*nonsteroidal anti-inflammatory drug


Advanced Ingredient Data


Raw Label Data

All Sections (JSON)