aleve ®

aleve ®
SPL v16
SPL
SPL Set ID 82891458-ab0d-459a-8602-dcebd22c3010
Route
oral
Published
Effective Date 2014-09-12
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
diphenhydramine (25 mg) naproxen (220 mg)
Inactive Ingredients
fd&c blue no. 2 aluminum oxide hypromelloses magnesium stearate cellulose, microcrystalline polyethylene glycol, unspecified carnauba wax povidone water talc titanium dioxide

Identifiers & Packaging

Pill Appearance
Imprint: ALEVE;PM Shape: oval Color: blue Size: 14 mm Score: 1
Marketing Status
nda active Since 2014-09-09

Description

Drug Facts


Medication Information

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.

Uses
  • for relief of occasional sleeplessness when associated with minor aches and pains
  • helps you fall asleep and stay asleep
Directions
  • do not take more than directed
  • drink a full glass of water with each dose
  • adults and children 12 years and over: take 2 caplets at bedtime
  • do not take more than 2 caplets in 24 hours
  • if taken with food, this product may take longer to work
Other Information
  • read all warnings and directions before use. Keep outer carton.
  • 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)
Inactive Ingredients

carnauba wax, FD&C blue #2 aluminum lake, hypromellose, magnesium stearate, microcrystalline cellulose, polyethylene glycol, povidone, purified water, talc, titanium dioxide

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 53414-9

If pregnant or breast-feeding, ask a health professional before use. It is especially important not to use naproxen sodium 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
Active ingredients (in each caplet) Purposes
Diphenhydramine hydrochloride 25 mg Nighttime sleep-aid
Naproxen sodium 220 mg (naproxen 200 mg) (NSAID)
nonsteroidal anti-inflammatory drug
Pain reliever
Do Not Use
  • if you have ever had an allergic reaction to any other pain reliever/fever reducer
  • unless you have time for a full night's sleep
  • in children under 12 years of age
  • right before or after heart surgery
  • with any other product containing diphenhydramine, even one used on skin
  • if you have sleeplessness without pain
Questions Or Comments?

1-800-395-0689 (Mon – Fri 9AM – 5PM EST)

When Using This Product
  • drowsiness will occur
  • avoid alcoholic drinks
  • do not drive a motor vehicle or operate machinery
  • take with food or milk if stomach upset occurs
Ask A Doctor Before Use If
  • stomach bleeding warning applies to you
  • you have problems or serious side effects from taking pain relievers or fever reducers
  • 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 a breathing problem such as emphysema or chronic bronchitis
  • you have glaucoma
  • you have trouble urinating due to an enlarged prostate gland
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 more than 10 days
  • sleeplessness persists continuously for more than 2 weeks. Insomnia may be a symptom of a serious underlying medical illness.
  • redness or swelling is present in the painful area
  • any new symptoms appear
  • you have difficulty swallowing
  • it feels like the pill is stuck in your throat
Ask A Doctor Or Pharmacist Before Use If You Are
  • taking sedatives or tranquilizers, or any other sleep-aid
  • 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 antihistamines
  • taking any other drug
Principal Display Panel 20 Tablet Bottle Carton

Aleve® PM

naproxen sodium, 220 mg (NSAID)/

diphenhydramine HCl, 25 mg

Pain reliever/nighttime sleep-aid

SLEEP AID PLUS

12 HOUR PAIN RELIEVING

STRENGTH OF ALEVE

ACTUAL SIZE

20 CAPLETS

*CAPSULE-SHAPED TABLETS


Structured Label Content

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.

Uses
  • for relief of occasional sleeplessness when associated with minor aches and pains
  • helps you fall asleep and stay asleep
Directions
  • do not take more than directed
  • drink a full glass of water with each dose
  • adults and children 12 years and over: take 2 caplets at bedtime
  • do not take more than 2 caplets in 24 hours
  • if taken with food, this product may take longer to work
Other Information (Other information)
  • read all warnings and directions before use. Keep outer carton.
  • 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)
Inactive Ingredients (Inactive ingredients)

carnauba wax, FD&C blue #2 aluminum lake, hypromellose, magnesium stearate, microcrystalline cellulose, polyethylene glycol, povidone, purified water, talc, titanium dioxide

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 53414-9 (53414-9)

If pregnant or breast-feeding, ask a health professional before use. It is especially important not to use naproxen sodium 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)
Active ingredients (in each caplet) Purposes
Diphenhydramine hydrochloride 25 mg Nighttime sleep-aid
Naproxen sodium 220 mg (naproxen 200 mg) (NSAID)
nonsteroidal anti-inflammatory drug
Pain reliever
Do Not Use (Do not use)
  • if you have ever had an allergic reaction to any other pain reliever/fever reducer
  • unless you have time for a full night's sleep
  • in children under 12 years of age
  • right before or after heart surgery
  • with any other product containing diphenhydramine, even one used on skin
  • if you have sleeplessness without pain
Questions Or Comments? (Questions or comments?)

1-800-395-0689 (Mon – Fri 9AM – 5PM EST)

When Using This Product (When using this product)
  • drowsiness will occur
  • avoid alcoholic drinks
  • do not drive a motor vehicle or operate machinery
  • take with food or milk if stomach upset occurs
Ask A Doctor Before Use If (Ask a doctor before use if)
  • stomach bleeding warning applies to you
  • you have problems or serious side effects from taking pain relievers or fever reducers
  • 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 a breathing problem such as emphysema or chronic bronchitis
  • you have glaucoma
  • you have trouble urinating due to an enlarged prostate gland
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 more than 10 days
  • sleeplessness persists continuously for more than 2 weeks. Insomnia may be a symptom of a serious underlying medical illness.
  • redness or swelling is present in the painful area
  • any new symptoms appear
  • you have difficulty swallowing
  • it feels like the pill is stuck in your throat
Ask A Doctor Or Pharmacist Before Use If You Are (Ask a doctor or pharmacist before use if you are)
  • taking sedatives or tranquilizers, or any other sleep-aid
  • 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 antihistamines
  • taking any other drug
Principal Display Panel 20 Tablet Bottle Carton (PRINCIPAL DISPLAY PANEL - 20 Tablet Bottle Carton)

Aleve® PM

naproxen sodium, 220 mg (NSAID)/

diphenhydramine HCl, 25 mg

Pain reliever/nighttime sleep-aid

SLEEP AID PLUS

12 HOUR PAIN RELIEVING

STRENGTH OF ALEVE

ACTUAL SIZE

20 CAPLETS

*CAPSULE-SHAPED TABLETS


Advanced Ingredient Data


Raw Label Data

All Sections (JSON)