{
  "meta": {
    "disclaimer": "Do not rely on openFDA to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. We may limit or otherwise restrict your access to the API in line with our Terms of Service.",
    "terms": "https://open.fda.gov/terms/",
    "license": "https://open.fda.gov/license/",
    "last_updated": "2026-06-12",
    "results": {
      "skip": 0,
      "limit": 1,
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  "results": [
    {
      "spl_product_data_elements": [
        "Naproxen Sodium and Diphenhydramine HCl Naproxen Sodium and Diphenhydramine HCl HYPROMELLOSE 2910 (3 MPA.S) MAGNESIUM STEARATE MICROCRYSTALLINE CELLULOSE POLYETHYLENE GLYCOL POVIDONE TALC TITANIUM DIOXIDE NAPROXEN SODIUM NAPROXEN DIPHENHYDRAMINE HYDROCHLORIDE DIPHENHYDRAMINE HYPROMELLOSE 2910 (6 MPA.S) FD&C BLUE NO. 2--ALUMINUM LAKE G;17"
      ],
      "active_ingredient": [
        "ACTIVE INGREDIENT(S) Diphenhydramine Hydrochloride 25 mg Naproxen Sodium 220 mg (naproxen 200 mg) (NSAID)* * nonsteroidal anti-inflammatory drug"
      ],
      "purpose": [
        "PURPOSE Night time sleep aid Pain reliever"
      ],
      "indications_and_usage": [
        "USE(S) for relief of occasional sleeplessness when associated with minor aches and pains helps you fall asleep and stay asleep"
      ],
      "warnings": [
        "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": [
        "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_doctor": [
        "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_doctor_or_pharmacist": [
        "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": [
        "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": [
        "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"
      ],
      "pregnancy_or_breast_feeding": [
        "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": [
        "KEEP OUT OF REACH OF CHILDREN In case of overdose, get medical help or contact a Poison Control Center right away."
      ],
      "dosage_and_administration": [
        "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"
      ],
      "spl_unclassified_section": [
        "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",
        "QUESTIONS OR COMMENTS ? Contact 1-877-770-3183 Mon-Fri 8:00 AM EST to 5:00 PM PST."
      ],
      "inactive_ingredient": [
        "INACTIVE INGREDIENTS FD&C blue2 aluminum lake, hypromellose, magnesiumstearate, microcrystalline cellulose, polyethyleneglycol, povidone, talc, titanium dioxide."
      ],
      "package_label_principal_display_panel": [
        "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 62207-814-38",
        "PRINCIPAL DISPLAY PANEL 62207-814-39"
      ],
      "set_id": "0d59780a-ef22-4b67-8b42-9795dbec8db0",
      "id": "3b4ca636-ecbd-6807-e063-6294a90a7765",
      "effective_time": "20250801",
      "version": "5",
      "openfda": {
        "application_number": [
          "ANDA213663"
        ],
        "brand_name": [
          "Naproxen Sodium and Diphenhydramine HCl"
        ],
        "generic_name": [
          "NAPROXEN SODIUM AND DIPHENHYDRAMINE HCL"
        ],
        "manufacturer_name": [
          "Granules India Ltd"
        ],
        "product_ndc": [
          "62207-814"
        ],
        "product_type": [
          "HUMAN OTC DRUG"
        ],
        "route": [
          "ORAL"
        ],
        "substance_name": [
          "DIPHENHYDRAMINE HYDROCHLORIDE",
          "NAPROXEN SODIUM"
        ],
        "rxcui": [
          "1550957"
        ],
        "spl_id": [
          "3b4ca636-ecbd-6807-e063-6294a90a7765"
        ],
        "spl_set_id": [
          "0d59780a-ef22-4b67-8b42-9795dbec8db0"
        ],
        "package_ndc": [
          "62207-814-95",
          "62207-814-47",
          "62207-814-38",
          "62207-814-39"
        ],
        "is_original_packager": [
          true
        ],
        "unii": [
          "TC2D6JAD40",
          "9TN87S3A3C"
        ]
      }
    }
  ]
}