{
  "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": "2026-07-18",
    "results": {
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  "results": [
    {
      "spl_product_data_elements": [
        "Back Pain Relief Extra Strength Doans Magnesium Salicylate Magnesium Salicylate Salicylic Acid POLYETHYLENE GLYCOL, UNSPECIFIED STEARIC ACID CELLULOSE, MICROCRYSTALLINE MAGNESIUM STEARATE POLYDEXTROSE TITANIUM DIOXIDE HYPROMELLOSE, UNSPECIFIED TRIACETIN white Caplet 44;338"
      ],
      "active_ingredient": [
        "ACTIVE INGREDIENT Active ingredient (in each caplet) Magnesium Salicylate Tetrahydrate (NSAID*) 580 mg (equivalent to 467.2 mg of anhydrous magnesium salicylate) *nonsteroidal anti-inflammatory drug"
      ],
      "purpose": [
        "PURPOSE Purpose Pain reliever"
      ],
      "indications_and_usage": [
        "INDICATIONS & USAGE Uses For the temporary relief of minor backache pain"
      ],
      "warnings": [
        "WARNINGS Warnings Reye's syndrome: Children and teenagers who have or are recovering from chicken pox or flu-like symptoms should not use this product. When using this product, if changes in behavior with nausea and vomiting occur, consult a doctor because these symptoms could be an early sign of Reye's syndrome, a rare but serious illness. Allergy alert: Magnesium salicylate may cause a severe allergic reaction, which may include: hives facial swelling asthma (wheezing) shock Stomach bleeding warning: This product contains an NSAID, which may cause severe stomach bleeding. The chance is higher if you: are age 60 or older have had stomach ulcers or bleeding problems take a blood thinning (anticoagulant) or steroid drug take other drugs containing prescription or nonprescription NSAIDs (aspirin, ibuprofen, naproxen, or others) have 3 or more alcohol drinks every day while using this product take more or for a longer time than directed DO NOT USE Do not use if you are allergic to salicylates (including aspirin) or any other pain reliever/fever reducer. ASK DOCTOR Ask a doctor before use if stomach bleeding warning applies to you you have a history of stomach problems such as heartburn you have high blood pressure, heart disease, liver cirrhosis, or kidney disease you have asthma you are taking a diuretic ASK DOCTOR/PHARMACIST Ask a doctor or pharmacist before use if you are taking a prescription drug for gout diabetes arthritis STOP USE Stop use and ask a doctor if an allergic reaction occurs. Seek medical help right away. you experience any of the following signs of stomach bleeding: feel faint vomit blood have bloody or black stools have stomach pain that does not get better ringing in the ears or loss of hearing occurs new symptoms occur pain gets worse or lasts more than 10 days fever gets worse or lasts more than 3 days 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. It is especially important not to use magnesium salicylate at 20 weeks or later in pregnancy unless definitely directed to do so by a doctor because it may cause problems in the unborn child or complications during delivery. KEEP OUT OF REACH OF CHILDREN Keep out of reach of children. 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 Do not use if you are allergic to salicylates (including aspirin) or any other pain reliever/fever reducer."
      ],
      "ask_doctor": [
        "ASK DOCTOR Ask a doctor before use if stomach bleeding warning applies to you you have a history of stomach problems such as heartburn you have high blood pressure, heart disease, liver cirrhosis, or kidney disease you have asthma you are taking a diuretic"
      ],
      "ask_doctor_or_pharmacist": [
        "ASK DOCTOR/PHARMACIST Ask a doctor or pharmacist before use if you are taking a prescription drug for gout diabetes arthritis"
      ],
      "stop_use": [
        "STOP USE Stop use and ask a doctor if an allergic reaction occurs. Seek medical help right away. you experience any of the following signs of stomach bleeding: feel faint vomit blood have bloody or black stools have stomach pain that does not get better ringing in the ears or loss of hearing occurs new symptoms occur pain gets worse or lasts more than 10 days fever gets worse or lasts more than 3 days redness or swelling is present These could be signs of a serious condition."
      ],
      "pregnancy_or_breast_feeding": [
        "PREGNANCY OR BREAST FEEDING If pregnant or breast-feeding, ask a health professional before use. It is especially important not to use magnesium salicylate at 20 weeks or later in pregnancy unless definitely directed to do so by a doctor because it may cause problems in the unborn child or complications during delivery."
      ],
      "keep_out_of_reach_of_children": [
        "KEEP OUT OF REACH OF CHILDREN Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center (1-800-222-1222) right away."
      ],
      "dosage_and_administration": [
        "DOSAGE & ADMINISTRATION Directions drink a full glass of water with each dose Adults and children: (12 years and over) Take 2 caplets every 6 hours, not to exceed 8 caplets in 24 hours. Children under 12 years: Do not use unless directed by a doctor"
      ],
      "other_safety_information": [
        "OTHER SAFETY INFORMATION Other information each caplet contains: magnesium 40 mg store at 25°C (77°F); excursions permitted between 15°-30°C (59°-86°F) tamper evident sealed packets do not use any opened or torn packets"
      ],
      "inactive_ingredient": [
        "INACTIVE INGREDIENT Inactive ingredients hypromellose, magnesium stearate, microcrystalline cellulose, polydextrose, polyethylene glycol, stearic acid, titanium dioxide, triacetin"
      ],
      "questions": [
        "QUESTIONS Questions or comments? (888) 602-0288"
      ],
      "package_label_principal_display_panel": [
        "Principal Display Panel – 50 Caplet Box Label 2550 BACK PAIN RELIEF Magnesium Salicylate Tetrahydrate 580 mg (NSAID) Pain Reliever / Anti-Inflammatory Pull to Open 50 Caplets 2 Per Packet The Provision First Aid Line™ BY WILDMAN Principal Display Panel – 50 Caplet Box Label"
      ],
      "set_id": "2e17664f-a83f-48d1-8b2b-37f41eea65b6",
      "id": "f69e4213-b807-4e45-9bc8-94c8f3449aae",
      "effective_time": "20240701",
      "version": "1",
      "openfda": {
        "application_number": [
          "M013"
        ],
        "brand_name": [
          "Back Pain Relief Extra Strength Doans"
        ],
        "generic_name": [
          "MAGNESIUM SALICYLATE"
        ],
        "manufacturer_name": [
          "Wildman Business Group"
        ],
        "product_ndc": [
          "84269-2550"
        ],
        "product_type": [
          "HUMAN OTC DRUG"
        ],
        "route": [
          "ORAL"
        ],
        "substance_name": [
          "MAGNESIUM SALICYLATE"
        ],
        "rxcui": [
          "198742",
          "830388"
        ],
        "spl_id": [
          "f69e4213-b807-4e45-9bc8-94c8f3449aae"
        ],
        "spl_set_id": [
          "2e17664f-a83f-48d1-8b2b-37f41eea65b6"
        ],
        "package_ndc": [
          "84269-2550-2"
        ],
        "is_original_packager": [
          true
        ],
        "upc": [
          "0858704004202"
        ],
        "unii": [
          "41728CY7UX"
        ]
      }
    }
  ]
}