Belmora Flanax

Belmora Flanax
SPL v10
SPL
SPL Set ID a44b8a82-251d-d5e8-e053-2a95a90a72f7
Route
ORAL
Published
Effective Date 2020-07-09
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Naproxen (220 mg)
Inactive Ingredients
Hypromellose, Unspecified Magnesium Stearate Polyethylene Glycol, Unspecified Povidone, Unspecified Microcrystalline Cellulose Fd&c Blue No. 2 Titanium Dioxide Silicon Dioxide Croscarmellose Sodium

Identifiers & Packaging

Pill Appearance
Imprint: 141 Shape: round Color: blue Size: 10 mm Score: 1
Marketing Status
ANDA Active Since 2020-07-20

Description

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

Uses

Temporarily relieves minor aches and pains due to:

■ backache

■ muscular aches

■ minor pain of arthritis

■ menstrual cramps

■ headache

■ toothache

■ the common cold

Temporarily reduces fever

Section 42229-5

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.

Section 50565-1

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

Section 50566-9

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

Section 50567-7

When using this product

■ take with food or milk if stomach upset occurs

Section 50568-5

Ask a doctor or pharmacist before use if you are

■ under a doctor’s care for any serious condition

■ taking any other drug

Section 50569-3

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 are taking a diuretic

■ you have problems or serious side effects from taking pain relievers or fever reducers

Section 50570-1

Do not use

■ if you ever have had an allergic reaction to any other pain reliever/fever reducer

■ right before or after heart surgery

Section 51945-4

Belmora LLC Flanax®

Pain Reliever/Fever Reducer

Longer Lasting Pain Relief

For Temporary Relief of Minor Aches & Pains

  • Headache
  • Backache
  • Arthritis
  • Fever
  • Menstrual Cramps
  • Toothache
  • Common Cold

20 Dual Packets

1 Tablet Per Packet/ 40 Tablets

220 mg Tablets Naproxen Sodium USP (NSAID)

Section 53414-9

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.

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 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

Active Ingredient

Naproxen Sodium USP 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

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

Questions Or Comments?

1-888-779-2877 M_F 9AM-5PM EST


Structured Label Content

Uses

Temporarily relieves minor aches and pains due to:

■ backache

■ muscular aches

■ minor pain of arthritis

■ menstrual cramps

■ headache

■ toothache

■ the common cold

Temporarily reduces fever

Section 42229-5 (42229-5)

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.

Section 50565-1 (50565-1)

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

Section 50566-9 (50566-9)

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

Section 50567-7 (50567-7)

When using this product

■ take with food or milk if stomach upset occurs

Section 50568-5 (50568-5)

Ask a doctor or pharmacist before use if you are

■ under a doctor’s care for any serious condition

■ taking any other drug

Section 50569-3 (50569-3)

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 are taking a diuretic

■ you have problems or serious side effects from taking pain relievers or fever reducers

Section 50570-1 (50570-1)

Do not use

■ if you ever have had an allergic reaction to any other pain reliever/fever reducer

■ right before or after heart surgery

Section 51945-4 (51945-4)

Belmora LLC Flanax®

Pain Reliever/Fever Reducer

Longer Lasting Pain Relief

For Temporary Relief of Minor Aches & Pains

  • Headache
  • Backache
  • Arthritis
  • Fever
  • Menstrual Cramps
  • Toothache
  • Common Cold

20 Dual Packets

1 Tablet Per Packet/ 40 Tablets

220 mg Tablets Naproxen Sodium USP (NSAID)

Section 53414-9 (53414-9)

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.

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 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

Active Ingredient (Active ingredient)

Naproxen Sodium USP 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)

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

Questions Or Comments? (Questions or comments?)

1-888-779-2877 M_F 9AM-5PM EST


Advanced Ingredient Data


Raw Label Data

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