Quality Plus 44-417 Headache Pain

Quality Plus 44-417 Headache Pain
SPL v6
SPL
SPL Set ID 6161b881-f422-47ae-86ba-a28d669bce79
Route
ORAL
Published
Effective Date 2025-06-18
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

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

Identifiers & Packaging

Pill Appearance
Imprint: 44;417 Shape: round Color: blue Size: 10 mm Score: 1
Marketing Status
ANDA Active Since 2020-09-16

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
  • temporarily relieves minor aches and pains due to:
    • headache
    • muscular aches
    • minor pain of arthritis
    • toothache
    • the common cold
    • menstrual cramps
    • backache
  • temporarily reduces fever
Warnings

Allergy alert: Naproxen sodium may cause a severe allergic reaction, especially in people allergic to aspirin. Symptoms may include:

  • hives
  • shock
  • rash
  • blisters
  • skin reddening
  • facial swelling
  • asthma (wheezing)

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
  • are age 60 or older
  • take a blood thinning (anticoagulant) or steroid drug
  • take more or for a longer time than directed
  • 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

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.

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
Do Not Use
  • if you have ever had an allergic reaction to any other pain reliever/fever reducer
  • right before or after heart surgery
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)
  • use by expiration date on package
Inactive Ingredients

croscarmellose sodium, FD&C blue #2 aluminum lake, magnesium stearate, microcrystalline cellulose, polyethylene glycol, polyvinyl alcohol, povidone, silicon dioxide, talc, titanium dioxide

Questions Or Comments?

Call 1-800-426-9391 8:30 AM-4:00 PM ET, Monday-Friday

Principal Display Panel

QUALITY

+PLUS

NDC 50844-471-16

Compare to

active ingredient in

Aleve® Headache Pain

Tablets

NAPROXEN

HEADACHE PAIN

NAPROXEN SODIUM

TABLETS, 220 mg

PAIN RELIEVER/FEVER

REDUCER (NSAID)

For temporary relief of minor headache pain

STRENGTH TO LAST

12 HOURS

1000

Coated Tablets

ACTUAL SIZE

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

BROKEN OR MISSING

This product is not manufactured or distributed by Bayer

HealthCare LLC, owner of the registered trademark Aleve®

Headache Pain Tablets.             50844      REV1221A41716

Distributed by: LNK INTERNATIONAL, INC.

60 Arkay Drive, Hauppauge, NY 11788

USA

Quality Plus 44-417 HP
When Using This Product
  • take with food or milk if stomach upset occurs
Ask A Doctor Before Use If
  • the stomach bleeding warning applies to you
  • you are taking a diuretic
  • 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
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:
    • weakness in one part or side of body
    • leg swelling
    • chest pain
    • slurred speech
    • trouble breathing
  • pain gets worse or lasts more than 10 days
  • you have difficulty swallowing
  • any new symptoms appear
  • fever gets worse or lasts more than 3 days
  • it feels like the pill is stuck in your throat
  • redness or swelling is present in the painful area
If Pregnant Or Breast Feeding,

ask a health professional before use. It is especially important not to use naproxen sodium at 20 weeks or later in 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 overdose, get medical help or contact a Poison Control Center right away.

Active Ingredient (in Each Tablet)

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

*nonsteroidal anti-inflammatory drug

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

Structured Label Content

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

  • hives
  • shock
  • rash
  • blisters
  • skin reddening
  • facial swelling
  • asthma (wheezing)

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
  • are age 60 or older
  • take a blood thinning (anticoagulant) or steroid drug
  • take more or for a longer time than directed
  • 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

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.

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
Do Not Use (Do not use)
  • if you have ever had an allergic reaction to any other pain reliever/fever reducer
  • right before or after heart surgery
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)
  • use by expiration date on package
Inactive Ingredients (Inactive ingredients)

croscarmellose sodium, FD&C blue #2 aluminum lake, magnesium stearate, microcrystalline cellulose, polyethylene glycol, polyvinyl alcohol, povidone, silicon dioxide, talc, titanium dioxide

Questions Or Comments? (Questions or comments?)

Call 1-800-426-9391 8:30 AM-4:00 PM ET, Monday-Friday

Principal Display Panel (Principal display panel)

QUALITY

+PLUS

NDC 50844-471-16

Compare to

active ingredient in

Aleve® Headache Pain

Tablets

NAPROXEN

HEADACHE PAIN

NAPROXEN SODIUM

TABLETS, 220 mg

PAIN RELIEVER/FEVER

REDUCER (NSAID)

For temporary relief of minor headache pain

STRENGTH TO LAST

12 HOURS

1000

Coated Tablets

ACTUAL SIZE

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

BROKEN OR MISSING

This product is not manufactured or distributed by Bayer

HealthCare LLC, owner of the registered trademark Aleve®

Headache Pain Tablets.             50844      REV1221A41716

Distributed by: LNK INTERNATIONAL, INC.

60 Arkay Drive, Hauppauge, NY 11788

USA

Quality Plus 44-417 HP
When Using This Product (When using this product)
  • take with food or milk if stomach upset occurs
Ask A Doctor Before Use If (Ask a doctor before use if)
  • the stomach bleeding warning applies to you
  • you are taking a diuretic
  • 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
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:
    • weakness in one part or side of body
    • leg swelling
    • chest pain
    • slurred speech
    • trouble breathing
  • pain gets worse or lasts more than 10 days
  • you have difficulty swallowing
  • any new symptoms appear
  • fever gets worse or lasts more than 3 days
  • it feels like the pill is stuck in your throat
  • redness or swelling is present in the painful area
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 at 20 weeks or later in 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 overdose, get medical help or contact a Poison Control Center right away.

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

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

*nonsteroidal anti-inflammatory drug

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 aspirin for heart attack or stroke, because naproxen may decrease this benefit of aspirin
  • taking any other drug

Advanced Ingredient Data


Raw Label Data

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