Label: GOOD SENSE NAPROXEN SODIUM- diphenhydramine hydrochloride, naproxen sodium tablet, film coated

  • NDC Code(s): 0113-8264-58, 0113-8264-60
  • Packager: L. Perrigo Company
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: Abbreviated New Drug Application

Drug Label Information

Updated February 11, 2021

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

  • Active ingredients (in each caplet)

    Diphenhydramine hydrochloride 25 mg

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

    *nonsteroidal anti-inflammatory drug

  • Purposes

    Nighttime sleep-aid

    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

    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.

    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, 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

    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

    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

    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

    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 (1-800-222-1222).

  • 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 21 mg
    store at 20-25°C (68-77°F)
    avoid high humidity and excessive heat above 40°C (104°F)
  • Inactive ingredients

    croscarmellose sodium, FD&C blue #1 aluminum lake, FD&C blue #2 aluminum lake, magnesium stearate, microcrystalline cellulose, polyethylene glycol, polyvinyl alcohol, povidone, silicon dioxide, talc, titanium dioxide

  • Questions or comments?

    1-800-719-9260

  • Package/Label Principal Display Panel

    Caplets

    Naproxen Sodium PM

    Naproxen Sodium and Diphenhydramine Hydrochloride Tablets, 220 mg/25 mg

    Actual Size

    Pain Reliever (NSAID) / Nighttime Sleep-aid

    Sleep Aid Plus 12-Hour Pain Reliever

    Compare to active ingredients of Aleve® pm

    40 Caplets**

    **Capsule-Shaped Tablets

    264-c2-naproxen-sodium-pm
  • INGREDIENTS AND APPEARANCE
    GOOD SENSE NAPROXEN SODIUM 
    diphenhydramine hydrochloride, naproxen sodium tablet, film coated
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:0113-8264
    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
    CROSCARMELLOSE SODIUM (UNII: M28OL1HH48)  
    FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
    FD&C BLUE NO. 2 (UNII: L06K8R7DQK)  
    MAGNESIUM STEARATE (UNII: 70097M6I30)  
    MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U)  
    POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A)  
    POLYVINYL ALCOHOL, UNSPECIFIED (UNII: 532B59J990)  
    POVIDONE, UNSPECIFIED (UNII: FZ989GH94E)  
    SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
    TALC (UNII: 7SEV7J4R1U)  
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
    Product Characteristics
    ColorBLUEScoreno score
    ShapeOVALSize15mm
    FlavorImprint Code L264
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:0113-8264-601 in 1 CARTON12/28/2018
    120 in 1 BOTTLE; Type 0: Not a Combination Product
    2NDC:0113-8264-581 in 1 CARTON06/06/2019
    240 in 1 BOTTLE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    ANDAANDA20849912/28/2018
    Labeler - L. Perrigo Company (006013346)