{
  "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": "2026-08-11",
    "results": {
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  "results": [
    {
      "spl_product_data_elements": [
        "Nighttime Sleep Aid Nighttime Sleep Aid 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(s) Doxylamine succinate 25 mg"
      ],
      "purpose": [
        "Purpose Nighttime sleep-aid"
      ],
      "indications_and_usage": [
        "Use(s) helps to reduce difficulty in falling asleep"
      ],
      "warnings": [
        "Warnings Do not use in children under 12 years of age Ask a doctor before use if you have a breathing problem such as emphysema or chronic bronchitis glaucoma difficulty in urination due to an enlargement of the prostate gland Ask a doctor or pharmacist before use if you are taking any other drugs. When using this product avoid alcoholic beverages take only at bedtime Stop use and ask a doctor if sleeplessness persists continuously for more than 2 weeks. Insomnia may be a symptom of a serious underlying medical illness. If pregnant or breastfeeding, ask a health professional before use. Keep out of reach of children Overdose Warning: In case of overdose, get medical help or contact a Poison Control Center (1-800-222-1222) right away."
      ],
      "do_not_use": [
        "Do not use in children under 12 years of age"
      ],
      "ask_doctor": [
        "Ask a doctor before use if you have a breathing problem such as emphysema or chronic bronchitis glaucoma difficulty in urination due to an enlargement of the prostate gland"
      ],
      "ask_doctor_or_pharmacist": [
        "Ask a doctor or pharmacist before use if you are taking any other drugs."
      ],
      "when_using": [
        "When using this product avoid alcoholic beverages take only at bedtime"
      ],
      "stop_use": [
        "Stop use and ask a doctor if sleeplessness persists continuously for more than 2 weeks. Insomnia may be a symptom of a serious underlying medical illness."
      ],
      "pregnancy_or_breast_feeding": [
        "If pregnant or breastfeeding, ask a health professional before use."
      ],
      "keep_out_of_reach_of_children": [
        "Keep out of reach of children Overdose Warning: In case of overdose, get medical help or contact a Poison Control Center (1-800-222-1222) right away."
      ],
      "dosage_and_administration": [
        "Directions Adults and children 12 years 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"
      ],
      "spl_unclassified_section": [
        "Other information DO NOT USE IF IMPRINTED SAFETY SEAL UNDER CAP IS BROKEN OR MISSING store at controlled room temperature 20°– 25°C (68°– 77°F) use by expiration date on package"
      ],
      "inactive_ingredient": [
        "Inactive ingredients dibasic calcium phosphate dihydrate, FD&C blue #1 aluminum lake, magnesium stearate, microcrystalline cellulose, sodium starch glycolate"
      ],
      "questions": [
        "Questions Call 1-888-952-0050 Monday through Friday 9AM - 5PM"
      ],
      "package_label_principal_display_panel": [
        "Principal Display Panel Nighttime sleep aid Nighttime sleep aid"
      ],
      "set_id": "3761182c-275b-40f3-a262-9ef5f5a80723",
      "id": "8accb0e9-d994-4b6a-acc3-4b416f3f65ba",
      "effective_time": "20230316",
      "version": "3",
      "openfda": {
        "application_number": [
          "ANDA040564"
        ],
        "brand_name": [
          "Nighttime Sleep Aid"
        ],
        "generic_name": [
          "NIGHTTIME SLEEP AID"
        ],
        "manufacturer_name": [
          "Allegiant Health"
        ],
        "product_ndc": [
          "69168-439"
        ],
        "product_type": [
          "HUMAN OTC DRUG"
        ],
        "route": [
          "ORAL"
        ],
        "substance_name": [
          "DOXYLAMINE SUCCINATE"
        ],
        "rxcui": [
          "1101446"
        ],
        "spl_id": [
          "8accb0e9-d994-4b6a-acc3-4b416f3f65ba"
        ],
        "spl_set_id": [
          "3761182c-275b-40f3-a262-9ef5f5a80723"
        ],
        "package_ndc": [
          "69168-439-06",
          "69168-439-84",
          "69168-439-40",
          "69168-439-98"
        ],
        "is_original_packager": [
          true
        ],
        "unii": [
          "V9BI9B5YI2"
        ]
      }
    }
  ]
}