Drug Facts

Drug Facts
SPL v4
SPL
SPL Set ID 03a331d8-c957-4949-894f-51d9bd15e0d0
Route
ORAL
Published
Effective Date 2025-08-20
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Naproxen (220 mg) Diphenhydramine (25 mg)
Inactive Ingredients
Carnauba Wax Fd&c Blue No. 2 Polyethylene Glycol, Unspecified Magnesium Stearate Hypromelloses Povidone Cellulose, Microcrystalline Talc Titanium Dioxide

Identifiers & Packaging

Pill Appearance
Imprint: AC37 Shape: capsule Color: blue Size: 15 mm Score: 1
Marketing Status
ANDA Completed Since 2018-12-31 Until 2026-12-31

Description

Diphenhydramine hydrochloride 25 mg Naproxen sodium 220 mg (naproxen 200 mg) (NSAID)* *nonsteroidal anti-inflammatory drug

Purpose

Nighttime sleep-aid Pain reliever


Medication Information

Purpose

Nighttime sleep-aid

Pain reliever

Description

Diphenhydramine hydrochloride 25 mg Naproxen sodium 220 mg (naproxen 200 mg) (NSAID)* *nonsteroidal anti-inflammatory drug

Uses
  • for relief of occasional sleeplessness when associated with minor aches and pains
  • help you fall asleep and stay asleep
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
  • have 3 or more alcoholic drinks every day while using this product  
  • take other drugs containing prescription or nonprescription NSAIDs (aspirin, ibuprofen, naproxen, or others)
  • 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
  • drink a full glass of water with each dose
  • adults and children 12 years and over:
  • take 2 tablets at bedtime
  • do not take more than 2 tablets in 24 hours
  • if taken with food, this product may take longer to work
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
Product Label
SUNMARK Naproxen PM
Other Information
  • each tablet contains: sodium 20 mg
  • read all warnings and directions before use. Keep carton.
  • store between 20º- 25ºC (68º-77ºF)
  • avoid high humidity and excessive heat above 40ºC (104ºF)
Inactive Ingredients

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

Questions Or Comments?

Call 1-877-753-3935 Monday-Friday 9AM-5PM EST

Principal Display Panel

COMPARE TO ALEVE® PM ACTIVE INGREDIENTS†

Naproxen  PM

Naproxen Sodium 220 mg

Pain reliever (NSAID)

Diphenhydramine HCI 25 mg/

Nighttime sleep-aid

COATED CAPLETS**

(**CAPSULES-SHAPED TABLETS)

†This product is not manufactured or distributed by Bayer Health Care, LLC, distributor of Aleve® PM

TAMPER EVIDENT: DO NOT USE IF PRINTED SAFETY SEAL UNDER CAP IS BROKEN OR MISSING.

KEEP OUTER CARTON FOR COMPLETE WARNINGS AND PRODUCT INGORMATION.

Another Quality Product Distributed by McKesson

One Post Street, San Francisco, CA 94104

www.sunmarkbrand.com

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
  • the stomach bleeding warning applies to you
  • you have problems or serious side effects from taking pain relievers or fever reducer
  • 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 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
    • have bloody or black stools  
    • vomit blood
    • 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 last 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
If Pregnant Or Breast Feeding,

ask a health professional before use. It is especially important not to use naproxen sodium during the last 3 months of 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 (1-800-222-1222) right away.

Active Ingredient (in Each Caplet)

Diphenhydramine hydrochloride 25 mg

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

*nonsteroidal anti-inflammatory drug

Ask A Doctor Or Pharmacist Before Use If You Are
  • taking sedatives or tranquilizer, or any other sleep-aid
  • under a doctor’s care for any serious condition
  • taking any other antihistamines
  • taking any other drug

Structured Label Content

Uses
  • for relief of occasional sleeplessness when associated with minor aches and pains
  • help you fall asleep and stay asleep
Purpose

Nighttime sleep-aid

Pain reliever

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
  • have 3 or more alcoholic drinks every day while using this product  
  • take other drugs containing prescription or nonprescription NSAIDs (aspirin, ibuprofen, naproxen, or others)
  • 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
  • drink a full glass of water with each dose
  • adults and children 12 years and over:
  • take 2 tablets at bedtime
  • do not take more than 2 tablets in 24 hours
  • if taken with food, this product may take longer to work
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
Product Label
SUNMARK Naproxen PM
Other Information (Other information)
  • each tablet contains: sodium 20 mg
  • read all warnings and directions before use. Keep carton.
  • store between 20º- 25ºC (68º-77ºF)
  • avoid high humidity and excessive heat above 40ºC (104ºF)
Inactive Ingredients (Inactive ingredients)

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

Questions Or Comments? (Questions or comments?)

Call 1-877-753-3935 Monday-Friday 9AM-5PM EST

Principal Display Panel

COMPARE TO ALEVE® PM ACTIVE INGREDIENTS†

Naproxen  PM

Naproxen Sodium 220 mg

Pain reliever (NSAID)

Diphenhydramine HCI 25 mg/

Nighttime sleep-aid

COATED CAPLETS**

(**CAPSULES-SHAPED TABLETS)

†This product is not manufactured or distributed by Bayer Health Care, LLC, distributor of Aleve® PM

TAMPER EVIDENT: DO NOT USE IF PRINTED SAFETY SEAL UNDER CAP IS BROKEN OR MISSING.

KEEP OUTER CARTON FOR COMPLETE WARNINGS AND PRODUCT INGORMATION.

Another Quality Product Distributed by McKesson

One Post Street, San Francisco, CA 94104

www.sunmarkbrand.com

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)
  • the stomach bleeding warning applies to you
  • you have problems or serious side effects from taking pain relievers or fever reducer
  • 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 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
    • have bloody or black stools  
    • vomit blood
    • 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 last 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
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 during the last 3 months of 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 (1-800-222-1222) right away.

Active Ingredient (in Each Caplet) (Active ingredient (in each caplet))

Diphenhydramine hydrochloride 25 mg

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)
  • taking sedatives or tranquilizer, or any other sleep-aid
  • under a doctor’s care for any serious condition
  • taking any other antihistamines
  • taking any other drug

Advanced Ingredient Data


Raw Label Data

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