{
  "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": "2026-10-30",
    "results": {
      "skip": 0,
      "limit": 1,
      "total": 1
    }
  },
  "results": [
    {
      "spl_product_data_elements": [
        "Pain Relief PM ACETAMINOPHEN, DIPHENHYDRAMINE DIPHENHYDRAMINE HYDROCHLORIDE DIPHENHYDRAMINE ACETAMINOPHEN ACETAMINOPHEN CROSCARMELLOSE SODIUM FD&C BLUE NO. 1 ALUMINUM LAKE FD&C BLUE NO. 2 ALUMINUM LAKE HYPROMELLOSE, UNSPECIFIED MAGNESIUM STEARATE MICROCRYSTALLINE CELLULOSE POLYETHYLENE GLYCOL, UNSPECIFIED POLYVINYL ALCOHOL POVIDONE K30 SILICON DIOXIDE SODIUM STARCH GLYCOLATE TYPE A STARCH, CORN TALC TITANIUM DIOXIDE P525"
      ],
      "active_ingredient": [
        "Active Ingredients (in each caplet) Acetaminophen 500 mg Diphenhydramine 25 mg"
      ],
      "purpose": [
        "Purpose Acetaminophen 500 mg ....................................................................................................................................Pain reliever Diphenhydramine HCl 25 mg ...........................................................................….................................Nighttime sleep aid"
      ],
      "indications_and_usage": [
        "Uses: temporary 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 hrs ■ with other drugs containing acetaminophen ■ 3 or more alcoholic drinks every day while using this product. Allergy alert: acetaminophen may cause severe skin reactions. Symptoms may include: ■ skin reddening ■ blisters ■ rash. If a skin reaction occurs, stop use and seek medical help right away."
      ],
      "do_not_use": [
        "Do Not use ■ with any other drug containing acetaminophen (prescription or nonprescription). If you are not sure whether a drug contains acetaminophen, ask a doctor or pharmacist ■ with any other product containing diphenhydramine, even one used on skin ■ in children under 12 years of age ■ if you have ever had an allergic reaction to this product or any of its ingredients."
      ],
      "ask_doctor": [
        "Ask a doctor before use if you have: ■ liver disease ■ glaucoma ■ a breathing problem such as emphysema or chronic bronchitis ■ trouble urinating due to an enlarged prostate gland."
      ],
      "ask_doctor_or_pharmacist": [
        "Ask a doctor or pharmacist before use if you are taking the blood thinning drug warfarin taking sedatives or tranquilizers"
      ],
      "when_using": [
        "When using this product ■ drowsiness will occur ■ avoid alcoholic drinks ■ do not drive a motor vehicle or operate machinery."
      ],
      "stop_use": [
        "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. ■ pain gets worse or lasts more than 10 days ■ fever gets worse or lasts more than 3 days ■ redness or swelling is present ■ new symptoms occur. These could be signs of a serious condition."
      ],
      "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 Overdose warning: In case of overdose, get medical help or contact Poison Control (1-800-222-1222) right away. 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 (see overdose warning) adults and children 12 years and over ■ take 2 caplets at bedtime ■ do not take more than 2 caplets in 24 hours unless directed by a doctor ■ children under 12 years do not use"
      ],
      "other_safety_information": [
        "Other Information: store at 20°-25°C (68°-77°F) do not use if foil or inner seal is broken or missing"
      ],
      "inactive_ingredient": [
        "Inactive Ingredients: Croscarmellose Sodium, FD & C Blue#1 Aluminium Lake, FD &C Blue#2 Aluminium Lake, Hypromelloses, Magnesium Stearate, Microcrystalline Cellulose, Polyethylene Glycol, Polyvinyl Alcohol, Povidone K30, Purified Water, Silicon Dioxide, Sodium Starch Glycolate, Starch Corn, Talc, Titanium Dioxide."
      ],
      "questions": [
        "Questions or Comments? Call 1-732-698-5070 Monday through Friday 9am to 5pm EST or visit www.pioneerlifesciences.com"
      ],
      "spl_unclassified_section": [
        "This product is not manufactured or distributed by Johnson & Johnson Consumer Inc., McNeil Consumer Healthcare Division., owner of the registered trademark Tylenol® Extra Strength Tablets. Distributed by: GenCare Consumer Products, LLC 40E Cotters Ln Suite A, East Brunswick, NJ 08816"
      ],
      "package_label_principal_display_panel": [
        "Rev 00 Pain Relief PM ES 375cts-PRINT"
      ],
      "set_id": "0181af13-da32-4431-be39-c31fdfac9202",
      "id": "3534d9ad-25c0-42ed-89d8-bc28ca3488dd",
      "effective_time": "20251229",
      "version": "2",
      "openfda": {
        "application_number": [
          "M013"
        ],
        "brand_name": [
          "Pain Relief PM"
        ],
        "generic_name": [
          "ACETAMINOPHEN, DIPHENHYDRAMINE"
        ],
        "manufacturer_name": [
          "Pioneer Life Sciences, LLC"
        ],
        "product_ndc": [
          "72090-032"
        ],
        "product_type": [
          "HUMAN OTC DRUG"
        ],
        "route": [
          "ORAL"
        ],
        "substance_name": [
          "DIPHENHYDRAMINE HYDROCHLORIDE",
          "ACETAMINOPHEN"
        ],
        "rxcui": [
          "1092189"
        ],
        "spl_id": [
          "3534d9ad-25c0-42ed-89d8-bc28ca3488dd"
        ],
        "spl_set_id": [
          "0181af13-da32-4431-be39-c31fdfac9202"
        ],
        "package_ndc": [
          "72090-032-01"
        ],
        "is_original_packager": [
          true
        ],
        "unii": [
          "TC2D6JAD40",
          "362O9ITL9D"
        ]
      }
    }
  ]
}