{
  "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,
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  },
  "results": [
    {
      "spl_product_data_elements": [
        "8HR Arthritis Pain Relief Acetaminophen 650mg SODIUM STARCH GLYCOLATE TYPE A HYDROXYETHYL CELLULOSE, UNSPECIFIED HYPROMELLOSE, UNSPECIFIED MAGNESIUM STEARATE TITANIUM DIOXIDE ACETAMINOPHEN ACETAMINOPHEN MICROCRYSTALLINE CELLULOSE POVIDONE, UNSPECIFIED STARCH, CORN TRIACETIN CARNAUBA WAX White to Off-White 71"
      ],
      "spl_unclassified_section": [
        "Drug Facts"
      ],
      "active_ingredient": [
        "Active ingredient (in each caplet) Acetaminophen 650 mg"
      ],
      "purpose": [
        "Purpose Pain reliever/fever reducer"
      ],
      "indications_and_usage": [
        "Uses 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"
      ],
      "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 use 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 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"
      ],
      "dosage_and_administration_table": [
        "<table border=\"0\" width=\"100%\"><tbody><tr><td>adults</td><td><list listType=\"unordered\"><item>take 2 caplets every 8 hours with water</item><item>swallow whole; do not crush, chew, split, or dissolve</item><item>do not take more than 6 caplets in 24 hours</item><item>do not use for more than 10 days unless directed by a doctor </item></list></td></tr><tr><td>under 18 years of age </td><td><list listType=\"unordered\"><item>ask a doctor</item></list></td></tr></tbody></table>"
      ],
      "other_safety_information": [
        "Other information store between 20-25ºC (68-77ºF) 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"
      ],
      "questions": [
        "Questions or comments? Call 1-877-290-4008"
      ],
      "package_label_principal_display_panel": [
        "CVS 699R Acetaminophen Tablets 100ct 699R Label"
      ],
      "set_id": "2eb6eba1-46af-32a4-e063-6294a90a499c",
      "id": "50839010-7c69-159b-e063-6394a90aadfa",
      "effective_time": "20260428",
      "version": "3",
      "openfda": {
        "application_number": [
          "ANDA215486"
        ],
        "brand_name": [
          "8HR Arthritis Pain Relief"
        ],
        "generic_name": [
          "ACETAMINOPHEN 650MG"
        ],
        "manufacturer_name": [
          "CVS Pharmacy"
        ],
        "product_ndc": [
          "51316-969"
        ],
        "product_type": [
          "HUMAN OTC DRUG"
        ],
        "route": [
          "ORAL"
        ],
        "substance_name": [
          "ACETAMINOPHEN"
        ],
        "rxcui": [
          "1148399"
        ],
        "spl_id": [
          "50839010-7c69-159b-e063-6394a90aadfa"
        ],
        "spl_set_id": [
          "2eb6eba1-46af-32a4-e063-6294a90a499c"
        ],
        "package_ndc": [
          "51316-969-01"
        ],
        "is_original_packager": [
          true
        ],
        "unii": [
          "362O9ITL9D"
        ]
      }
    }
  ]
}