aleve ®
82891458-ab0d-459a-8602-dcebd22c3010
34390-5
HUMAN OTC DRUG LABEL
Drug Facts
Composition & Product
Identifiers & Packaging
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)
Additional Information
Back to search View SPL set listing Open on DailyMed ↗
Source: dailymed · Ingested: 2026-02-15T12:07:28.232227 · Updated: 2026-03-14T23:10:57.415546