Signature Select 44-604

Signature Select 44-604
SPL v5
SPL
SPL Set ID 3eeb07fe-fcf1-4ea7-b0c2-9cb04f88c041
Route
ORAL
Published
Effective Date 2026-02-13
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;604 Shape: oval Color: blue Size: 12 mm Score: 1
Marketing Status
ANDA Active Since 2023-10-11

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
    • the common cold
    • toothache
    • backache
    • menstrual cramps
    • minor pain of arthritis
  • temporarily reduces fever
Warnings

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

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

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 a blood thinning (anticoagulant) or steroid drug
  • take other drugs containing prescription or nonprescription NSAIDs [aspirin, ibuprofen, naproxen, or others]
  • are age 60 or older
  • have 3 or more alcoholic drinks every day while using this product
  • take more or for a longer time than directed

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 caplet every 8 to 12 hours while symptoms last
    • for the first dose you may take 2 caplets within the first hour
    • do not exceed 2 caplets in any 8- to 12-hour period
    • do not exceed 3 caplets 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 caplet 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

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

COMPARE TO

Aleve® Caplets Active Ingredient

NDC 21130-856-52

Signature

SELECT

NAPROXEN

SODIUM

TABLETS, 220 mg (NSAID)

Pain Reliever/

Fever Reducer 

12 HOUR STRENGTH

Actual Size

90 CAPLETS**

**CAPSULE-SHAPED TABLETS

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, distributors of Aleve® Caplets.

50844 REV1221B60452

♥︎ LOVE IT

OR IT'S ON US

DISTRIBUTED BY: BETTER LIVING BRANDS LLC

P.O. BOX 99, PLEASANTON, CA 94566-0009

1-888-723-3929

Scan here

for more

information

Signature Select 44-604
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 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 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:
    • 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 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 Caplet)

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
    • the common cold
    • toothache
    • backache
    • menstrual cramps
    • minor pain of arthritis
  • 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:

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

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 a blood thinning (anticoagulant) or steroid drug
  • take other drugs containing prescription or nonprescription NSAIDs [aspirin, ibuprofen, naproxen, or others]
  • are age 60 or older
  • have 3 or more alcoholic drinks every day while using this product
  • take more or for a longer time than directed

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 caplet every 8 to 12 hours while symptoms last
    • for the first dose you may take 2 caplets within the first hour
    • do not exceed 2 caplets in any 8- to 12-hour period
    • do not exceed 3 caplets 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 caplet 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

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)

COMPARE TO

Aleve® Caplets Active Ingredient

NDC 21130-856-52

Signature

SELECT

NAPROXEN

SODIUM

TABLETS, 220 mg (NSAID)

Pain Reliever/

Fever Reducer 

12 HOUR STRENGTH

Actual Size

90 CAPLETS**

**CAPSULE-SHAPED TABLETS

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, distributors of Aleve® Caplets.

50844 REV1221B60452

♥︎ LOVE IT

OR IT'S ON US

DISTRIBUTED BY: BETTER LIVING BRANDS LLC

P.O. BOX 99, PLEASANTON, CA 94566-0009

1-888-723-3929

Scan here

for more

information

Signature Select 44-604
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 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 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:
    • 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, (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 Caplet) (Active ingredient (in each caplet))

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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