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

Drug Label Information

Updated February 9, 2023

If you are a healthcare professional or from the pharmaceutical industry 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 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 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 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.

    • 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: Do not use if foil inner seal under the cap is opened 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

    nap-diphen-carton-label-jpg

  • 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

    nap-diphen-label-jpg

  • 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)