{
  "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": "2026-06-02",
    "results": {
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  "results": [
    {
      "spl_product_data_elements": [
        "Sleep Aid Doxylamine Succinate DOXYLAMINE SUCCINATE DOXYLAMINE DIBASIC CALCIUM PHOSPHATE DIHYDRATE FD&C BLUE NO. 1 ALUMINUM LAKE MAGNESIUM STEARATE MICROCRYSTALLINE CELLULOSE SODIUM STARCH GLYCOLATE TYPE A POTATO 44;386"
      ],
      "active_ingredient": [
        "Active ingredient (in each tablet) Doxylamine succinate 25 mg"
      ],
      "purpose": [
        "Purpose Nighttime sleep-aid"
      ],
      "indications_and_usage": [
        "Use helps to reduce difficulty in falling asleep"
      ],
      "warnings": [
        "Warnings Do not use in children under 12 years of age with any other product containing doxylamine unless you have time for a full night’s sleep Ask a doctor before use if you have a breathing problem such as emphysema or chronic bronchitis glaucoma trouble urinating due to an enlarged prostate gland Ask a doctor or pharmacist before use if you are taking sedatives or any other sleep-aid tranquilizers any other antihistamines any other drugs When using this product avoid alcoholic beverages do not drive a motor vehicle or operate machinery take only at bedtime Stop use and ask a doctor if sleeplessness persists continuously for more than two weeks. Insomnia may be a symptom of serious underlying medical illness. If pregnant or breast-feeding, ask a health professional before use. Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center right away."
      ],
      "do_not_use": [
        "Do not use in children under 12 years of age with any other product containing doxylamine unless you have time for a full night’s sleep"
      ],
      "ask_doctor": [
        "Ask a doctor before use if you have a breathing problem such as emphysema or chronic bronchitis glaucoma trouble urinating due to an enlarged prostate gland"
      ],
      "ask_doctor_or_pharmacist": [
        "Ask a doctor or pharmacist before use if you are taking sedatives or any other sleep-aid tranquilizers any other antihistamines any other drugs"
      ],
      "when_using": [
        "When using this product avoid alcoholic beverages do not drive a motor vehicle or operate machinery take only at bedtime"
      ],
      "stop_use": [
        "Stop use and ask a doctor if sleeplessness persists continuously for more than two weeks. Insomnia may be a symptom of serious underlying medical illness."
      ],
      "pregnancy_or_breast_feeding": [
        "If pregnant or breast-feeding, ask a health professional before use."
      ],
      "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 adults and children 12 years of age and over: take one tablet 30 minutes before going to bed; take once daily or as directed by a doctor children under 12 years of age: do not use"
      ],
      "storage_and_handling": [
        "Other information TAMPER EVIDENT: DO NOT USE IF OUTER PACKAGE IS OPENED OR BLISTER IS TORN OR BROKEN store at controlled room temperature 20°-25°C (68°-77°F) see end flap for expiration date and lot number"
      ],
      "inactive_ingredient": [
        "Inactive ingredients dibasic calcium phosphate dihydrate, FD&C blue #1 aluminum lake, magnesium stearate, microcrystalline cellulose, sodium starch glycolate"
      ],
      "questions": [
        "Questions or comments? Call 1-855-423-2630 Mon-Fri 8 am to 6 pm CST"
      ],
      "package_label_principal_display_panel": [
        "Principal display panel EQUAL INE® compare to Unisom® SleepTabs® active ingredient* NDC 41163-986-22 nighttime sleep aid doxylamine succinate tablets, 25 mg (nighttime sleep aid) • just one tablet per dose 48 mini tablets actual size TAMPER EVIDENT: DO NOT USE IF PACKAGE IS OPENED OR IF BLISTER UNIT IS TORN, BROKEN OR SHOWS ANY SIGNS OF TAMPERING *This product is not manufactured or distributed by Chattem, Inc., owner of the registered trademark Unisom® SleepTabs®. 50844 REV0123D38622 DISTRIBUTED BY UNFI PROVIDENCE, RI 02908 USA 855-423-2630 100% Quality GUARANTEED Equaline 44-386 Equaline 44-386"
      ],
      "set_id": "005b5ad8-d762-46b5-a7a5-e0ff11ba936a",
      "id": "67863f1b-c028-41f8-8980-05c9452c215a",
      "effective_time": "20260406",
      "version": "9",
      "openfda": {
        "application_number": [
          "ANDA040564"
        ],
        "brand_name": [
          "Sleep Aid"
        ],
        "generic_name": [
          "DOXYLAMINE SUCCINATE"
        ],
        "manufacturer_name": [
          "United Natural Foods, Inc. dba UNFI"
        ],
        "product_ndc": [
          "41163-986"
        ],
        "product_type": [
          "HUMAN OTC DRUG"
        ],
        "route": [
          "ORAL"
        ],
        "substance_name": [
          "DOXYLAMINE SUCCINATE"
        ],
        "rxcui": [
          "1101446"
        ],
        "spl_id": [
          "67863f1b-c028-41f8-8980-05c9452c215a"
        ],
        "spl_set_id": [
          "005b5ad8-d762-46b5-a7a5-e0ff11ba936a"
        ],
        "package_ndc": [
          "41163-986-22"
        ],
        "is_original_packager": [
          true
        ],
        "upc": [
          "0041163256354"
        ],
        "unii": [
          "V9BI9B5YI2"
        ]
      }
    }
  ]
}