{
  "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": "2026-06-02",
    "results": {
      "skip": 0,
      "limit": 1,
      "total": 1
    }
  },
  "results": [
    {
      "spl_product_data_elements": [
        "Defensol D Blister Pack Acetaminophen, Diphenhydramine HCl, Phenylephrine HCI MICROCRYSTALLINE CELLULOSE SILICON DIOXIDE POLYETHYLENE GLYCOL, UNSPECIFIED FD&C BLUE NO. 1 MAGNESIUM STEARATE POVIDONE STARCH, PREGELATINIZED CORN STEARIC ACID TITANIUM DIOXIDE ACETAMINOPHEN ACETAMINOPHEN DIPHENHYDRAMINE HYDROCHLORIDE DIPHENHYDRAMINE PHENYLEPHRINE HYDROCHLORIDE PHENYLEPHRINE SODIUM BICARBONATE TALC METHACRYLIC ACID - ETHYL ACRYLATE COPOLYMER (1:2) CROSPOVIDONE FERRIC OXIDE YELLOW POLYVINYL ALCOHOL, UNSPECIFIED CROSCARMELLOSE SODIUM FD&C BLUE NO. 2"
      ],
      "active_ingredient": [
        "Active ingredients (in each tablet) Acetaminophen 325 mg Diphenhydramine HCl 12.5 mg Phenylephrine HCI 5 mg"
      ],
      "purpose": [
        "Purpose Pain Reliever Antihistamine/ Cough Suppresant Nasal Decongestant"
      ],
      "indications_and_usage": [
        "Uses Temporarily relieves these symptoms associated with cold or flu: headache nasal congestion sore throat fever minor aches and pains Temporarily relieves minor aches, pains, and headache as well as those symptoms of hay fever or other upper respiratory allergies: runny nose sneezing nasal congestion itching of the nose or throat itchy, watery eyes Temporarily relieves minor aches, pains, headache, and nasal congestion as well as sinus congestion and pressure, and reduces swelling of nasal passages"
      ],
      "warnings": [
        "Warnings Liver Warning: This product contains acetaminophen. Severe liver damage may occur if you take more than 8 tablets in any 24-hour period, which is the maximum daily amount with other drugs containing acetaminophen 3 or more alcoholic drinks every day while using this product Severe throat warning: if sore throat is severe, persists for more than 2 days, is accompanied or followed by fever, headache, rash, nausea, or vomiting, consult a doctor promptly. 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 now taking a prescription monoamine oxidase inhibitor (MAOI) (certain drugs for depression, psychiatric, or emotional conditions, or Parkinson's disease), or for 2 weeks after stopping the MADI drug. If you do not know if your prescription drug contains MADI, ask a doctor or pharmacist befaretakingthisprocluct. ■ if you have ever had an allergic reaction to this product or any of its ingredients ■ to sedate a child or to make a child sleepy ■ with any other product containing diphenhydramine, even one used on skin."
      ],
      "ask_doctor": [
        "Ask doctor before use if you have liver desease heart disease high blood pressure thyroid disease diabetes trouble urinating due to an enlarged prostate gland glaucoma a breathing problem such as emphysema, asthma, or chronic bronchitis taking the blood thinning drug warfarin taking any other oral nasal decongestant or stimulant taking any other pain relieve/fever reducer taking sedatives or tranquilizers"
      ],
      "when_using": [
        "When using this product do not use more than directed drowsiness may occur avoid alcoholic drinks alcohol, sedatives, and tranquilizers may increase drowsiness be careful when driving a motor vehicle or operating machinery excitability may occur in children"
      ],
      "stop_use": [
        "Stop use and ask a doctor if you get nervous, dizzy, or sleepless pain or nasal congestion gets worse or lasts more than 7 days fever gets worse or lasts more than 3 days redness or swelling is present new symptoms occur"
      ],
      "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."
      ],
      "overdosage": [
        "Overdose warning: In case of overdose, get medical help or contact a Poison Control Center right away. Prompt 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 12 tablets in a 24 hour period. do not exceed recommended dosage. Taking more than the recommended dose (overdose) may cause serious liver damage. This adult product is not intended for use in children under 12 years of age age dose adults and children 12 years and over 2 tablets every 4 hours children under 12 years do not use"
      ],
      "dosage_and_administration_table": [
        "<table width=\"100%\"><caption/><tbody><tr><td> age</td><td> dose</td></tr><tr><td> adults and children 12 years and over</td><td> 2 tablets every 4 hours</td></tr><tr><td> children under 12 years</td><td> do not use</td></tr></tbody></table>"
      ],
      "inactive_ingredient": [
        "Inactive ingredients corn starch, croscarmellose sodium, crospovidone, FD&C blue#1 aluminum lake, FO&C blue#2 aluminum lake, iron oxide yellow, magnesium stearate, methacrylic acid, and ethyl acrylate copolymer, microcrystalline cellulose, polyethylene glycol, polyvinyl alcohol, povidone, s I con dioxide, sodium bicarbonate, stearic acid, talc, titanium oxide."
      ],
      "questions": [
        "Questions? Menper Distributors, Inc. 1-800-560-5223; M-F 9 AM - 4 PM Eastern"
      ],
      "package_label_principal_display_panel": [
        "Pack"
      ],
      "set_id": "0dfcc977-6101-4536-e063-6294a90a7a48",
      "id": "3a893b13-e7eb-c5b1-e063-6394a90a4253",
      "effective_time": "20250722",
      "version": "2",
      "openfda": {
        "application_number": [
          "M012"
        ],
        "brand_name": [
          "Defensol D Blister Pack"
        ],
        "generic_name": [
          "ACETAMINOPHEN, DIPHENHYDRAMINE HCL, PHENYLEPHRINE HCI"
        ],
        "manufacturer_name": [
          "Menper Distributors, Inc."
        ],
        "product_ndc": [
          "53145-009"
        ],
        "product_type": [
          "HUMAN OTC DRUG"
        ],
        "route": [
          "ORAL"
        ],
        "substance_name": [
          "ACETAMINOPHEN",
          "DIPHENHYDRAMINE HYDROCHLORIDE",
          "PHENYLEPHRINE HYDROCHLORIDE"
        ],
        "rxcui": [
          "1233575"
        ],
        "spl_id": [
          "3a893b13-e7eb-c5b1-e063-6394a90a4253"
        ],
        "spl_set_id": [
          "0dfcc977-6101-4536-e063-6294a90a7a48"
        ],
        "package_ndc": [
          "53145-009-30"
        ],
        "is_original_packager": [
          true
        ],
        "unii": [
          "362O9ITL9D",
          "TC2D6JAD40",
          "04JA59TNSJ"
        ]
      }
    }
  ]
}