Aleve Liquid Gels

Aleve Liquid Gels
SPL v2
SPL
SPL Set ID a0587c73-d297-462d-a0ef-750cb324486e
Route
ORAL
Published
Effective Date 2024-05-06
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Naproxen (220 mg)
Inactive Ingredients
Ammonia Fd&c Blue No. 1 Gelatin, Unspecified Glycerin Lactic Acid, Unspecified Form Mannitol Polyethylene Glycol, Unspecified Polyvinyl Acetate Phthalate Povidone, Unspecified Propylene Glycol Water Sorbitan Sorbitol Titanium Dioxide

Identifiers & Packaging

Pill Appearance
Imprint: P797 Shape: capsule Color: blue Size: 25 mm Score: 1
Marketing Status
ANDA Active Since 2023-12-01
Description

Drug Facts

Medication Information

Warnings and Precautions

Warnings

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.

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 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)
  • 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.

Indications and Usage

Uses

  • temporarily relieves minor aches and pains due to:
  • minor pain of arthritis
  • muscular aches
  • backache
  • menstrual cramps
  • headache
  • toothache
  • the common cold
  • temporarily reduces fever
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
  • if taken with food, this product may take longer to work
Adults and children 12

years and older
  • take 1 capsule every 8 to 12 hours

    while symptoms last
  • for the first dose you may take

    2 capsules within the first hour
  • do not exceed 2 capsules in any

    8- to 12-hour period
  • do not exceed 3 capsules in a

    24-hour period
Children under 12 years
  • ask a doctor
Description

Drug Facts

Section 42229-5

Drug Facts

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 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
  • slurred speech
  • weakness in one part or side of body
  • leg swelling
  • pain gets worse or lasts more than 10 days
  • fever gets worse or lasts more than 3 days
  • redness or swelling is present in the painful area
  • any new symptoms appear
  • you have difficulty swallowing
  • it feels like the capsule is stuck in your throat
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 aspirin for heart attack or stroke, because naproxen may decrease this benefit of aspirin
  • taking any other drug
Section 50569-3

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
Section 50570-1

Do not use

  • if you have ever had an allergic reaction to any other pain reliever/fever reducer
  • right before or after heart surgery
Section 51727-6

Inactive ingredients ammonium hydroxide, FD&C blue #1, gelatin, glycerin, lactic acid, mannitol, polyethylene glycol, polyvinyl acetate phthalate, povidone, propylene glycol, purified water, sorbitan-sorbitol solution, titanium dioxide

Section 51945-4
Section 53413-1

Questions or comments? 1-800-395-0689

(Mon-Fri 9AM – 5PM EST)

Section 53414-9

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.

Section 55105-1

Purposes

Pain Reliever/Fever Reducer

Section 55106-9

Active ingredient (in each capsule)

Naproxen Sodium 220mg (Naproxen 200mg) (NSAID)*

*nonsteroidal anti-inflammatory drug

Section 60561-8

Other information

  • each capsule contains: sodium 20 mg
  • store at 20°-25°C (68°-77°F). Avoid high humidity and excessive heat above 40°C (104°F).
  • protect from light
  • read all directions and warnings before use.
Principal Display Panel 20 Capsules Label

ALL DAY STRONG®

ALEVE®

LIQUID GELS

naproxen sodium capsules, 220 mg (NSAID)

Pain Reliever/Fever Reducer

BAYER

ALEVE

STRENGTH TO

LAST 12 HOURS

20CAPSULES

(LIQUID FILLED CAPSULES)

Principal Display Panel 50 Capsules Label

ALL DAY STRONG®

ALEVE®

LIQUID GELS

naproxen sodium capsules, 220 mg (NSAID)

Pain Reliever/Fever Reducer

BAYER

ALEVE

STRENGTH TO

LAST 12 HOURS

50CAPSULES

(LIQUID FILLED CAPSULES)

Principal Display Panel 80 Capsules Label

ALL DAY STRONG®

ALEVE®

LIQUID GELS

naproxen sodium capsules, 220 mg (NSAID)

Pain Reliever/Fever Reducer

BAYER

ALEVE

STRENGTH TO

LAST 12 HOURS

80CAPSULES

(LIQUID FILLED CAPSULES)

Principal Display Panel 120 Capsules Label

ALL DAY STRONG®

ALEVE®

LIQUID GELS

naproxen sodium capsules, 220 mg (NSAID)

Pain Reliever/Fever Reducer

BAYER

ALEVE

STRENGTH TO

LAST 12 HOURS

120CAPSULES

(LIQUID FILLED CAPSULES)

Principal Display Panel 160 Capsules Label

ALL DAY STRONG®

ALEVE®

LIQUID GELS

Naproxen Sodium Capsules, 200 mg (NSAID)

Pain Reliever/Fever Reducer

ALEVE

BAYER

STRENGTH TO

LAST 12 HOURS

160CAPSULES

LIQUID FILLED CAPSULES

Principal Display Panel 20 Capsules Carton

ALL DAY STRONG®

ALEVE®

LIQUID GELS

Naproxen Sodium Capsules, 220 mg (NSAID)

Pain Reliever/Fever Reducer

BAYER

ALEVE

ACTUAL SIZE

STRENGTH

TO LAST

12 HOURS

20

CAPSULES

(LIQUID FILLED CAPSULES)

Principal Display Panel 50 Capsules Carton

ALL DAY STRONG®

ALEVE®

LIQUID GELS

Naproxen Sodium Capsules, 220 mg (NSAID)

Pain Reliever/Fever Reducer

BAYER

ALEVE

ACTUAL SIZE

STRENGTH

TO LAST

12 HOURS

50

CAPSULES

(LIQUID FILLED CAPSULES)

Principal Display Panel 80 Capsules Carton

ALL DAY STRONG®

ALEVE®

LIQUID GELS

Naproxen Sodium Capsules, 220 mg (NSAID)

Pain Reliever/Fever Reducer

BAYER

ALEVE

ACTUAL SIZE

STRENGTH

TO LAST

12 HOURS

80

CAPSULES

(LIQUID FILLED CAPSULES)

Principal Display Panel 120 Capsules Carton

120

LIQUID FILLED CAPSULES

ALL DAY STRONG®

ALEVE®

LIQUID GELS

Naproxen Sodium Capsules, 220 mg (NSAID)

Pain Reliever/Fever Reducer

BAYER

ALEVE

ACTUAL SIZE

STRENGTH

TO LAST

12 HOURS

120

CAPSULES

(LIQUID FILLED CAPSULES)

Structured Label Content

Indications and Usage (34067-9)

Uses

  • temporarily relieves minor aches and pains due to:
  • minor pain of arthritis
  • muscular aches
  • backache
  • menstrual cramps
  • headache
  • toothache
  • the common cold
  • 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
  • if taken with food, this product may take longer to work
Adults and children 12

years and older
  • take 1 capsule every 8 to 12 hours

    while symptoms last
  • for the first dose you may take

    2 capsules within the first hour
  • do not exceed 2 capsules in any

    8- to 12-hour period
  • do not exceed 3 capsules in a

    24-hour period
Children under 12 years
  • ask a doctor
Warnings and Precautions (34071-1)

Warnings

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.

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 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)
  • 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.

Section 42229-5 (42229-5)

Drug Facts

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 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
  • slurred speech
  • weakness in one part or side of body
  • leg swelling
  • pain gets worse or lasts more than 10 days
  • fever gets worse or lasts more than 3 days
  • redness or swelling is present in the painful area
  • any new symptoms appear
  • you have difficulty swallowing
  • it feels like the capsule is stuck in your throat
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 aspirin for heart attack or stroke, because naproxen may decrease this benefit of aspirin
  • taking any other drug
Section 50569-3 (50569-3)

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
Section 50570-1 (50570-1)

Do not use

  • if you have ever had an allergic reaction to any other pain reliever/fever reducer
  • right before or after heart surgery
Section 51727-6 (51727-6)

Inactive ingredients ammonium hydroxide, FD&C blue #1, gelatin, glycerin, lactic acid, mannitol, polyethylene glycol, polyvinyl acetate phthalate, povidone, propylene glycol, purified water, sorbitan-sorbitol solution, titanium dioxide

Section 51945-4 (51945-4)
Section 53413-1 (53413-1)

Questions or comments? 1-800-395-0689

(Mon-Fri 9AM – 5PM EST)

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 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.

Section 55105-1 (55105-1)

Purposes

Pain Reliever/Fever Reducer

Section 55106-9 (55106-9)

Active ingredient (in each capsule)

Naproxen Sodium 220mg (Naproxen 200mg) (NSAID)*

*nonsteroidal anti-inflammatory drug

Section 60561-8 (60561-8)

Other information

  • each capsule contains: sodium 20 mg
  • store at 20°-25°C (68°-77°F). Avoid high humidity and excessive heat above 40°C (104°F).
  • protect from light
  • read all directions and warnings before use.
Principal Display Panel 20 Capsules Label (PRINCIPAL DISPLAY PANEL - 20 Capsules Label)

ALL DAY STRONG®

ALEVE®

LIQUID GELS

naproxen sodium capsules, 220 mg (NSAID)

Pain Reliever/Fever Reducer

BAYER

ALEVE

STRENGTH TO

LAST 12 HOURS

20CAPSULES

(LIQUID FILLED CAPSULES)

Principal Display Panel 50 Capsules Label (PRINCIPAL DISPLAY PANEL - 50 Capsules Label)

ALL DAY STRONG®

ALEVE®

LIQUID GELS

naproxen sodium capsules, 220 mg (NSAID)

Pain Reliever/Fever Reducer

BAYER

ALEVE

STRENGTH TO

LAST 12 HOURS

50CAPSULES

(LIQUID FILLED CAPSULES)

Principal Display Panel 80 Capsules Label (PRINCIPAL DISPLAY PANEL - 80 Capsules Label)

ALL DAY STRONG®

ALEVE®

LIQUID GELS

naproxen sodium capsules, 220 mg (NSAID)

Pain Reliever/Fever Reducer

BAYER

ALEVE

STRENGTH TO

LAST 12 HOURS

80CAPSULES

(LIQUID FILLED CAPSULES)

Principal Display Panel 120 Capsules Label (PRINCIPAL DISPLAY PANEL - 120 Capsules Label)

ALL DAY STRONG®

ALEVE®

LIQUID GELS

naproxen sodium capsules, 220 mg (NSAID)

Pain Reliever/Fever Reducer

BAYER

ALEVE

STRENGTH TO

LAST 12 HOURS

120CAPSULES

(LIQUID FILLED CAPSULES)

Principal Display Panel 160 Capsules Label (PRINCIPAL DISPLAY PANEL - 160 Capsules Label)

ALL DAY STRONG®

ALEVE®

LIQUID GELS

Naproxen Sodium Capsules, 200 mg (NSAID)

Pain Reliever/Fever Reducer

ALEVE

BAYER

STRENGTH TO

LAST 12 HOURS

160CAPSULES

LIQUID FILLED CAPSULES

Principal Display Panel 20 Capsules Carton (PRINCIPAL DISPLAY PANEL - 20 Capsules Carton)

ALL DAY STRONG®

ALEVE®

LIQUID GELS

Naproxen Sodium Capsules, 220 mg (NSAID)

Pain Reliever/Fever Reducer

BAYER

ALEVE

ACTUAL SIZE

STRENGTH

TO LAST

12 HOURS

20

CAPSULES

(LIQUID FILLED CAPSULES)

Principal Display Panel 50 Capsules Carton (PRINCIPAL DISPLAY PANEL - 50 Capsules Carton)

ALL DAY STRONG®

ALEVE®

LIQUID GELS

Naproxen Sodium Capsules, 220 mg (NSAID)

Pain Reliever/Fever Reducer

BAYER

ALEVE

ACTUAL SIZE

STRENGTH

TO LAST

12 HOURS

50

CAPSULES

(LIQUID FILLED CAPSULES)

Principal Display Panel 80 Capsules Carton (PRINCIPAL DISPLAY PANEL - 80 Capsules Carton)

ALL DAY STRONG®

ALEVE®

LIQUID GELS

Naproxen Sodium Capsules, 220 mg (NSAID)

Pain Reliever/Fever Reducer

BAYER

ALEVE

ACTUAL SIZE

STRENGTH

TO LAST

12 HOURS

80

CAPSULES

(LIQUID FILLED CAPSULES)

Principal Display Panel 120 Capsules Carton (PRINCIPAL DISPLAY PANEL - 120 Capsules Carton)

120

LIQUID FILLED CAPSULES

ALL DAY STRONG®

ALEVE®

LIQUID GELS

Naproxen Sodium Capsules, 220 mg (NSAID)

Pain Reliever/Fever Reducer

BAYER

ALEVE

ACTUAL SIZE

STRENGTH

TO LAST

12 HOURS

120

CAPSULES

(LIQUID FILLED CAPSULES)

Advanced Ingredient Data

Raw Label Data

All Sections (JSON)

Additional Information

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Source: dailymed · Ingested: 2026-02-15T12:03:03.985845 · Updated: 2026-03-14T23:02:55.861635