Belmora Flanax Private Label Distributor

Belmora Flanax Private Label Distributor
SPL v4
SPL
SPL Set ID 8591ca57-04ee-5053-e053-2991aa0aa4dd
Route
ORAL
Published
Effective Date 2020-04-22
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Naproxen (220 mg)
Inactive Ingredients
Povidone Starch, Corn Titanium Dioxide Magnesium Stearate Fd&c Blue No. 2 Polyethylene Glycol, Unspecified Polyvinyl Alcohol, Unspecified Talc Croscarmellose

Identifiers & Packaging

Pill Appearance
Imprint: I;3 Shape: round Color: blue Size: 9 mm Score: 1
Marketing Status
ANDA Active Since 2008-12-30

Description

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

Purpose

Pain reliever/fever reducer


Medication Information

Purpose

Pain reliever/fever reducer

Description

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

Uses

Temporary relieves minor aches and pains due to:

  • minor pain of arthritis
  • backache
  • headache
  • the common cold
  • muscular aches
  • menstrual cramps
  • toothache

Temporarily reduces fever

Directions
  • do not take more than directed
  • the smallest effective dose should be used
  • drink a full glass of water with each dose

Adults: (12 years of age 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

Do Not Use
  • if you ever have had an allergic reaction to any other pain reliever/fever reducer
  • right before or after heart surgery
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.

Active Ingredient

Naproxen Sodium 220 mg

(naproxen 200 mg) (NSAID)*

*nonsteroidal anti-inflammatory drug

Other Information
  • each tablet contains: sodium 20 mg
  • store at 68-77ºF (20-25ºC)
  • avoid high humidity and excessive heat above 104ºF (40ºC)
  • tamper evident sealed packets
  • do not use any open or torn packets
Inactive Ingredients

croscarmellose sodium, FD&C blue #2, macrogol, magnesium stearate, polyvinyl alcohol, povidone, pregelatinized starch, talc, titanium dioxide

Source Ndc 47682 237

Flanax®

Pain Reliever/Fever Reducer

Longer Lasting Pain Relief

For Temporary Relief Of Minor Aches & Pains

20 Dual Packets

1 Tablet Per Packet

40 Tablets

220MG Tablets Naproxen Sodium USP (NSAID)

Questions Or Comments?

1-888-779-2877

M-F 9AM-5PM EST

Belmora LLC, 2231 Crystal Dr. Suite 1000, Arlington, VA 22202

When Using This Product
  • take with food or milk if stomach upset occurs
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 stomach ulcers or bleeding problems
  • take a blood thinner (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
Ask A Doctor Before Use If
  • 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 are taking a diuretic
  • you have problems or serious side effects from taking pain relievers or fever reducers
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:

■ chest pain ■ trouble breathing ■ weakness in one part or side of body ■ slurred speech ■ leg swelling

■ pain gets worse or lasts for more than 10 days

■ fever gets worse or lasts for 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.

Keep Out of Reach of Children.

In case of accidental overdose, get medical help or contact a Poison Control Center right away.

Heart Attack and Stroke Warning:

NSAID, 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

Ask A Doctor Or Pharmacist Before Use If You Are
  • under a doctor's care for any serious condition
  • taking any other drug

Structured Label Content

Uses

Temporary relieves minor aches and pains due to:

  • minor pain of arthritis
  • backache
  • headache
  • the common cold
  • muscular aches
  • menstrual cramps
  • toothache

Temporarily reduces fever

Purpose

Pain reliever/fever reducer

Directions
  • do not take more than directed
  • the smallest effective dose should be used
  • drink a full glass of water with each dose

Adults: (12 years of age 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

Do Not Use (Do not use)
  • if you ever have had an allergic reaction to any other pain reliever/fever reducer
  • right before or after heart surgery
Allergy Alert: (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.

Active Ingredient (Active ingredient)

Naproxen Sodium 220 mg

(naproxen 200 mg) (NSAID)*

*nonsteroidal anti-inflammatory drug

Other Information (Other information)
  • each tablet contains: sodium 20 mg
  • store at 68-77ºF (20-25ºC)
  • avoid high humidity and excessive heat above 104ºF (40ºC)
  • tamper evident sealed packets
  • do not use any open or torn packets
Inactive Ingredients (Inactive ingredients)

croscarmellose sodium, FD&C blue #2, macrogol, magnesium stearate, polyvinyl alcohol, povidone, pregelatinized starch, talc, titanium dioxide

Source Ndc 47682 237 (Source NDC 47682-237)

Flanax®

Pain Reliever/Fever Reducer

Longer Lasting Pain Relief

For Temporary Relief Of Minor Aches & Pains

20 Dual Packets

1 Tablet Per Packet

40 Tablets

220MG Tablets Naproxen Sodium USP (NSAID)

Questions Or Comments? (Questions or comments?)

1-888-779-2877

M-F 9AM-5PM EST

Belmora LLC, 2231 Crystal Dr. Suite 1000, Arlington, VA 22202

When Using This Product (When using this product)
  • take with food or milk if stomach upset occurs
Stomach Bleeding Warning: (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 stomach ulcers or bleeding problems
  • take a blood thinner (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
Ask A Doctor Before Use If (Ask a doctor before use if)
  • 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 are taking a diuretic
  • you have problems or serious side effects from taking pain relievers or fever reducers
Stop Use and Ask A Doctor If (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:

■ chest pain ■ trouble breathing ■ weakness in one part or side of body ■ slurred speech ■ leg swelling

■ pain gets worse or lasts for more than 10 days

■ fever gets worse or lasts for 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 (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.

Keep Out of Reach of Children. (Keep out of reach of children.)

In case of accidental overdose, get medical help or contact a Poison Control Center right away.

Heart Attack and Stroke Warning: (Heart attack and stroke warning:)

NSAID, 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

Ask A Doctor Or Pharmacist Before Use If You Are (Ask a doctor or pharmacist before use if you are)
  • under a doctor's care for any serious condition
  • taking any other drug

Advanced Ingredient Data


Raw Label Data

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