Label: NAPROXEN SODIUM AND DIPHENHYDRAMINE HCL tablet, film coated

  • NDC Code(s): 62207-814-38, 62207-814-39, 62207-814-47, 62207-814-95
  • Packager: Granules India Ltd
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: Abbreviated New Drug Application

Drug Label Information

Updated March 7, 2022

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

  • ACTIVE INGREDIENT(S)

    Diphenhydramine Hydrochloride 25 mg

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

    * nonsteroidal anti-inflammatory drug

  • PURPOSE

    Night time sleep-aid

    Pain reliever

  • USE(S)

    • 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, Drug Facts Drug Facts 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

    • 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 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 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 BREASTFEEDING

    ask a health professional before use. It is especially important not to use naproxen sodium at 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.

  • 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 to 25°C (68 to 77°F).
    • avoid high humidity and excessive heat above 40°C (104°F).

    • TAMPER-EVIDENT BOTTLE DO NOT USE IF INNER FOIL SEAL IMPRINTED WITH “SEALED for YOUR PROTECTION” IS BROKEN OR MISSING
  • INACTIVE INGREDIENTS

    FD&C blue2 aluminum lake, hypromellose, magnesiumstearate, microcrystalline cellulose, polyethyleneglycol, povidone, talc, titanium dioxide.

  • QUESTIONS OR COMMENTS ?

    Contact 1-877-770-3183
    Mon-Fri 8:00 AM EST to 5:00 PM PST.

  • PRINCIPAL DISPLAY PANEL

    Naproxen Sodium and
    Diphenhydramine HCl Tablets
    220 mg/25 mg (NSAID)


    Pain Reliever/Nighttime sleep-aid

    SLEEP AID PLUS

    12 HOUR PAIN RELIEVING

    COMPARE TO THE ACTIVE INGREDIENTS OF ALEVE PM

    20 Caplets

    †Capsule-Shaped Tablets

    carton

  • PRINCIPAL DISPLAY PANEL

    Naproxen Sodium and
    Diphenhydramine HCl Tablets
    220 mg/25 mg (NSAID)


    Pain Reliever/Nighttime sleep-aid

    SLEEP AID PLUS

    12 HOUR PAIN RELIEVING

    COMPARE TO THE ACTIVE INGREDIENTS OF ALEVE PM

    500 Caplets†

    †Capsule-Shaped Tablets

    500-label

  • PRINCIPAL DISPLAY PANEL

    nap-diphen-label1-jpg

  • PRINCIPAL DISPLAY PANEL

    nap-diphen-label2-jpg

  • INGREDIENTS AND APPEARANCE
    NAPROXEN SODIUM AND DIPHENHYDRAMINE HCL 
    naproxen sodium and diphenhydramine hcl tablet, film coated
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:62207-814
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    NAPROXEN SODIUM (UNII: 9TN87S3A3C) (NAPROXEN - UNII:57Y76R9ATQ) NAPROXEN SODIUM220 mg
    DIPHENHYDRAMINE HYDROCHLORIDE (UNII: TC2D6JAD40) (DIPHENHYDRAMINE - UNII:8GTS82S83M) DIPHENHYDRAMINE HYDROCHLORIDE25 mg
    Inactive Ingredients
    Ingredient NameStrength
    FD&C BLUE NO. 2--ALUMINUM LAKE (UNII: 4AQJ3LG584)  
    HYPROMELLOSE 2910 (3 MPA.S) (UNII: 0VUT3PMY82)  
    MAGNESIUM STEARATE (UNII: 70097M6I30)  
    MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U)  
    POLYETHYLENE GLYCOL (UNII: 3WJQ0SDW1A)  
    POVIDONE (UNII: FZ989GH94E)  
    TALC (UNII: 7SEV7J4R1U)  
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
    HYPROMELLOSE 2910 (6 MPA.S) (UNII: 0WZ8WG20P6)  
    Product Characteristics
    ColorblueScoreno score
    ShapeCAPSULESize15mm
    FlavorImprint Code G;17
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:62207-814-951 in 1 CARTON02/20/2021
    120 in 1 BOTTLE; Type 0: Not a Combination Product
    2NDC:62207-814-47500 in 1 BOTTLE; Type 0: Not a Combination Product02/20/2021
    3NDC:62207-814-3837500 in 1 POUCH; Type 0: Not a Combination Product02/20/2021
    4NDC:62207-814-397500 in 1 POUCH; Type 0: Not a Combination Product02/20/2021
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    ANDAANDA21366302/20/2021
    Labeler - Granules India Ltd (915000087)