Label: ALEVE PM- diphenhydramine hydrochloride and naproxen sodium tablet, film coated

  • NDC Code(s): 0280-1200-02, 0280-1200-20, 0280-1200-40, 0280-1200-80
  • Packager: Bayer HealthCare LLC.
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: New Drug Application

Drug Label Information

Updated November 4, 2019

If you are a consumer or patient please visit this version.

  • SPL UNCLASSIFIED SECTION

    Drug Facts

  • ACTIVE INGREDIENT

    Active ingredients (in each caplet)Purposes
    *
    nonsteroidal anti-inflammatory drug
    Diphenhydramine hydrochloride 25 mgNighttime sleep-aid
    Naproxen sodium 220 mg (naproxen 200 mg) (NSAID) *Pain reliever
  • Uses

    • for relief of occasional sleeplessness when associated with minor aches and pains
    • helps 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
    • 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

    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

    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, or asthma
    • 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

    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 any other antihistamines
    • taking any other drug

    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
    • the risk of heart attack or stroke may increase if you use more than directed or for longer than directed

    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
      • 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

    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 right away.

  • 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

  • Questions or comments?

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

  • 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

    20 CAPLETS*

    *CAPSULE-SHAPED TABLETS

    Label 20 count carton

  • INGREDIENTS AND APPEARANCE
    ALEVE PM 
    diphenhydramine hydrochloride and naproxen sodium tablet, film coated
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:0280-1200
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    DIPHENHYDRAMINE HYDROCHLORIDE (UNII: TC2D6JAD40) (DIPHENHYDRAMINE - UNII:8GTS82S83M) DIPHENHYDRAMINE HYDROCHLORIDE25 mg
    NAPROXEN SODIUM (UNII: 9TN87S3A3C) (NAPROXEN - UNII:57Y76R9ATQ) NAPROXEN SODIUM220 mg
    Inactive Ingredients
    Ingredient NameStrength
    CARNAUBA WAX (UNII: R12CBM0EIZ)  
    FD&C BLUE NO. 2 (UNII: L06K8R7DQK)  
    ALUMINUM OXIDE (UNII: LMI26O6933)  
    HYPROMELLOSES (UNII: 3NXW29V3WO)  
    MAGNESIUM STEARATE (UNII: 70097M6I30)  
    CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)  
    POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A)  
    POVIDONE (UNII: FZ989GH94E)  
    WATER (UNII: 059QF0KO0R)  
    TALC (UNII: 7SEV7J4R1U)  
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
    Product Characteristics
    ColorblueScoreno score
    ShapeOVALSize14mm
    FlavorImprint Code ALEVE;PM
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:0280-1200-022 in 1 POUCH; Type 0: Not a Combination Product09/09/2014
    2NDC:0280-1200-201 in 1 CARTON09/09/2014
    220 in 1 BOTTLE; Type 0: Not a Combination Product
    3NDC:0280-1200-401 in 1 CARTON09/09/2014
    340 in 1 BOTTLE; Type 0: Not a Combination Product
    4NDC:0280-1200-801 in 1 CARTON09/09/2014
    480 in 1 BOTTLE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    NDANDA20535209/09/2014
    Labeler - Bayer HealthCare LLC. (112117283)
    Establishment
    NameAddressID/FEIBusiness Operations
    Bayer HealthCare LLC Consumer Care072827066manufacture(0280-1200) , pack(0280-1200)
    Establishment
    NameAddressID/FEIBusiness Operations
    Bayer Bitterfeld GMBH330908898manufacture(0280-1200) , pack(0280-1200)