{
  "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": 3
    }
  },
  "results": [
    {
      "spl_product_data_elements": [
        "Acetaminophen Acetaminophen tablet extended release STARCH, CORN POVIDONE K30 MAGNESIUM STEARATE HYPROMELLOSE, UNSPECIFIED TRIACETIN CARNAUBA WAX TITANIUM DIOXIDE CELLULOSE, MICROCRYSTALLINE SODIUM STARCH GLYCOLATE TYPE A HYDROXYETHYL CELLULOSE (140 MPA.S AT 5%) ACETAMINOPHEN ACETAMINOPHEN White to off white 71"
      ],
      "active_ingredient": [
        "Active ingredient (in each caplet) Acetaminophen 650 mg"
      ],
      "purpose": [
        "Purpose Pain reliever/fever reducer"
      ],
      "indications_and_usage": [
        "Uses For Arthritis Pain temporarily relieves minor aches and pains due to: minor pain of arthritis muscular aches backache premenstrual and menstrual cramps the common cold headache toothache temporarily reduces fever For Muscle Aches & Pains temporarily relieves minor aches and pains due to: muscular aches backache minor pain of arthritis toothache premenstrual and menstrual cramps headache the common cold temporarily reduces fever"
      ],
      "warnings": [
        "Warnings Liver warning: This product contains acetaminophen. Severe liver damage may occur if you take more than 6 caplets in 24 hours, which is the maximum daily amount 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. if you are allergic to acetaminophen or any of the inactive ingredients in this product."
      ],
      "ask_doctor": [
        "Ask a doctor before use if you have liver disease."
      ],
      "ask_doctor_or_pharmacist": [
        "Ask a doctor or pharmacist before use if you are taking the blood thinning drug warfarin."
      ],
      "stop_use": [
        "Stop using and ask a doctor if pain gets worse or lasts more than 10 days fever gets worse or lasts more than 3 days new symptoms occur redness or swelling is present 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 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 For Arthritis Pain Do not take more than directed. See overdose warning adults: take 2 caplets every 8 hours with water swallow whole; do not crush, chew, split or dissolve do not take more than 6 caplets in 24 hours do not use for more than 10 days unless directed by a doctor under 18 years of age: ask a doctor For Muscle Aches & Pains Do not take more than directed. See overdose warning adults and children 12 years and over: take 2 caplets every 8 hours with water swallow whole; do not crush, chew, split or dissolve do not take more than 6 caplets in 24 hours do not use for more than 10 days unless directed by a doctor children under 12 years: do not use"
      ],
      "storage_and_handling": [
        "Other information store between 20-25°C (68-77°F) The FDA approved Dissolution methods differ from USP"
      ],
      "inactive_ingredient": [
        "Inactive ingredients carnauba wax, hydroxyethyl cellulose, hypromellose, magnesium stearate, microcrystalline cellulose, povidone, pregelatinized starch, sodium starch glycolate, titanium dioxide, triacetin"
      ],
      "other_safety_information": [
        "Questions or comments? Call 1-877-290-4008"
      ],
      "package_label_principal_display_panel": [
        "PACKAGE LABEL.PRINCIPAL DISPLAY PANEL Relabeled and Repackaged by: Enovachem PHARMACEUTICALS Torrance, CA 90501 label"
      ],
      "set_id": "4ef6bc2b-03cf-474f-bb9e-dbb5792ec197",
      "id": "2ef14964-4fa1-9fb6-e063-6294a90aff36",
      "effective_time": "20250224",
      "version": "2",
      "openfda": {
        "application_number": [
          "ANDA215486"
        ],
        "brand_name": [
          "Acetaminophen"
        ],
        "generic_name": [
          "ACETAMINOPHEN TABLET EXTENDED RELEASE"
        ],
        "manufacturer_name": [
          "Asclemed USA, Inc."
        ],
        "product_ndc": [
          "76420-914"
        ],
        "product_type": [
          "HUMAN OTC DRUG"
        ],
        "route": [
          "ORAL"
        ],
        "substance_name": [
          "ACETAMINOPHEN"
        ],
        "rxcui": [
          "1148399"
        ],
        "spl_id": [
          "2ef14964-4fa1-9fb6-e063-6294a90aff36"
        ],
        "spl_set_id": [
          "4ef6bc2b-03cf-474f-bb9e-dbb5792ec197"
        ],
        "package_ndc": [
          "76420-914-40",
          "76420-914-01",
          "76420-914-05",
          "76420-914-26",
          "76420-914-42",
          "76420-914-60"
        ],
        "original_packager_product_ndc": [
          "49483-699"
        ],
        "unii": [
          "362O9ITL9D"
        ]
      }
    }
  ]
}