{
  "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": "2026-06-09",
    "results": {
      "skip": 0,
      "limit": 1,
      "total": 2
    }
  },
  "results": [
    {
      "spl_product_data_elements": [
        "ACETAMINOPHEN PM ACETAMINOPHEN PM CROSCARMELLOSE SODIUM FD&C BLUE NO. 1 HYPROMELLOSES CELLULOSE, MICROCRYSTALLINE POLYETHYLENE GLYCOL 400 POVIDONE SILICON DIOXIDE STARCH, CORN STEARIC ACID TITANIUM DIOXIDE ACETAMINOPHEN ACETAMINOPHEN DIPHENHYDRAMINE HYDROCHLORIDE DIPHENHYDRAMINE AP;133"
      ],
      "active_ingredient": [
        "Active Ingredient (in each caplet) Acetaminophen 500 mg Diphenhydramine HCl 25 mg"
      ],
      "purpose": [
        "Purpose Pain Reliever / Night time sleep aid"
      ],
      "indications_and_usage": [
        "Uses temporarily relief of occasional headaches and minor aches and pains with accompanying sleeplessness"
      ],
      "warnings": [
        "Warnings Liver warning: This product contains acetaminophen. Severe liver damage may occur if you take more than 4,000 mg of acetaminophen in 24 hours with other drugs containing acetaminophen 3 or more alcoholic drinks every day while using this product do not use with any other drug containing acetaminophen (prescription or non prescription). If you are not sure whether a drug contains acetaminophen, ask a doctor or pharmacist. with any other drug containing diphenhydramine, even one used on skin in children under 12 years of age Ask a doctor before use if the you have liver disease glaucoma a breathing problem such as emphysema or chronic bronchitis trouble urinating due to an enlarged prostate gland Ask a doctor or pharmacist before use if you are taking the blood thinning drug warfarin taking sedative or tranquilizers when using this product drowsiness will occur avoid alcoholic drinks do not drive a motor vehicle or operate machinery Stop use and ask a doctor if sleeplessness persists continuously for more than 2 weeks, insomnia may be a symptom of serious underlying medical illness. Any new symptoms appear redness or swelling is present pain gets worse or lasts more than 10 days fever gets worse or lasts more than 3 days If pregnant or breast-feeding, ask a health professional before use."
      ],
      "keep_out_of_reach_of_children": [
        "Keep out of reach of children. Overdose warning: Taking more than the recommended dose (overdose) may cause liver damage. In case of overdose, get medical help or contact a Poison Control Center right away. (1-800-222-1222) Quick medical attention is critical for adults as well as for children even if you do not notice any signs or symptoms."
      ],
      "dosage_and_administration": [
        "Directions do not take more than directed adults and children 12 years and over: take 2 caplets at bedtime if needed or as directed by a doctor children under 12 years : do not use this adult product in children under 12 years of age; this will provide more than the recommended dose(overdose) and may cause liver damage"
      ],
      "spl_unclassified_section": [
        "Other Information store at 15-30 °C (59-86 °F)"
      ],
      "inactive_ingredient": [
        "Inactive Ingredients crosscarmellose sodium, FD&C blue # 1, hypromellose, microcrystalline cellulose, polyethylene glycol 400, povidone, silicon dioxide, starch, stearic acid, titanium dioxide"
      ],
      "questions": [
        "Questions or Comments Call 631-981-4600 8.30 am- 4.30 pm ET, Monday-Friday TAMPER EVIDENT: DO NOT USE IF IMPRINTED SAFETY SEAL UNDER CAP IS BROKEN OR MISSING Manufactured by: Advance Pharmaceutical, Inc. Holtsville, NY 11742"
      ],
      "package_label_principal_display_panel": [
        "PACKAGE LABEL.PRINCIPAL DISPLAY PANEL NDC: 17714-133-50 – 50 COUNT CAPLETS 079fcfcb-figure-01 079fcfcb-figure-02"
      ],
      "set_id": "b172226e-8f2a-4d9c-b7c7-dd737b90463a",
      "id": "60f41580-e074-faad-e053-2a91aa0a9076",
      "effective_time": "20171222",
      "version": "2",
      "openfda": {
        "application_number": [
          "part341"
        ],
        "brand_name": [
          "ACETAMINOPHEN PM"
        ],
        "generic_name": [
          "ACETAMINOPHEN PM"
        ],
        "manufacturer_name": [
          "Advance Pharmaceutical Inc."
        ],
        "product_ndc": [
          "17714-133"
        ],
        "product_type": [
          "HUMAN OTC DRUG"
        ],
        "route": [
          "ORAL"
        ],
        "substance_name": [
          "ACETAMINOPHEN",
          "DIPHENHYDRAMINE HYDROCHLORIDE"
        ],
        "rxcui": [
          "1092189"
        ],
        "spl_id": [
          "60f41580-e074-faad-e053-2a91aa0a9076"
        ],
        "spl_set_id": [
          "b172226e-8f2a-4d9c-b7c7-dd737b90463a"
        ],
        "package_ndc": [
          "17714-133-50"
        ],
        "is_original_packager": [
          true
        ],
        "upc": [
          "0017714133504"
        ],
        "unii": [
          "362O9ITL9D",
          "TC2D6JAD40"
        ]
      }
    }
  ]
}