{
  "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": 3
    }
  },
  "results": [
    {
      "spl_product_data_elements": [
        "PHARBEDRYL Diphenhydramine HCl 50mg FERROSOFERRIC OXIDE D&C RED NO. 28 FD&C BLUE NO. 1 FD&C RED NO. 40 GELATIN LACTOSE MONOHYDRATE MAGNESIUM STEARATE SILICON DIOXIDE SODIUM LAURYL SULFATE DIPHENHYDRAMINE HYDROCHLORIDE DIPHENHYDRAMINE Pink/ Pink PH013"
      ],
      "active_ingredient": [
        "Active ingredient (in each banded capsule) Diphenhydramine HCl 50mg Purpose Antihistamine"
      ],
      "purpose": [
        "Purpose Antihistamine"
      ],
      "indications_and_usage": [
        "Uses temporarily relieves these symptoms due to hay fever or other upper respiratory allergies: runny nose sneezing itchy, watery eyes itching of the nose or throat temporarily relieves these symptoms due to common cold: runny nose sneezing"
      ],
      "warnings": [
        "Warnings"
      ],
      "do_not_use": [
        "Do not use with any other product containing diphenhydramine, even one used on skin"
      ],
      "ask_doctor": [
        "Ask a doctor before use if you have 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 sedatives or tranquilizers."
      ],
      "when_using": [
        "When using this product drowsiness may occur avoid alcoholic drinks alcohol, sedatives & tranquilizers may increase drowsiness use caution when driving a motor vehicle or operating machinery excitability may occur, especially in children"
      ],
      "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. In case of overdose, get medical help or contact a Poison Control Center right away (1-800-222-1222)."
      ],
      "dosage_and_administration": [
        "Directions take every 4 to 6 hours, or as directed by a doctor do not exceed 6 doses in 24 hours adults and children 12 years and over 1 capsule children under 12 years ask a doctor"
      ],
      "dosage_and_administration_table": [
        "<table width=\"63%\" border=\"1\" cellspacing=\"0\" cellpadding=\"0\"><tbody><tr><td valign=\"top\"><paragraph>adults and children 12 years and over</paragraph></td><td valign=\"top\"><paragraph>1 capsule</paragraph></td></tr><tr><td valign=\"top\"><paragraph>children under 12 years</paragraph></td><td valign=\"top\"><paragraph>ask a doctor</paragraph></td></tr></tbody></table>"
      ],
      "storage_and_handling": [
        "Other information store at 20-25 o C (68-77 o F)"
      ],
      "inactive_ingredient": [
        "Inactive ingredients black iron oxide, D&C red #28, FD&C blue #1, FD&C red #40, gelatin, lactose monohydrate, magnesium stearate, silicon dioxide, sodium lauryl sulfate"
      ],
      "questions": [
        "Questions or comments? (866) 562-2756 (Mon- Fri 8 AM to 4 PM EST)"
      ],
      "package_label_principal_display_panel": [
        "PHARBEST NDC 73057-347-11 Manufactured in the USA PHARBEDRYL Diphenhydramine HCl 50 mg Antihistamine •Sneezing •Runny Nose •Itchy, Watery Eyes •Itchy Throat 1000 CAPSULES Ulai Pharbedryl 50mg Capsule 1000ct Capsule Label"
      ],
      "set_id": "135293fb-5674-4638-be55-b968cf51257e",
      "id": "2c2777c1-a456-d152-e063-6294a90a7539",
      "effective_time": "20250120",
      "version": "3",
      "openfda": {
        "application_number": [
          "M010"
        ],
        "brand_name": [
          "PHARBEDRYL"
        ],
        "generic_name": [
          "DIPHENHYDRAMINE HCL 50MG"
        ],
        "manufacturer_name": [
          "Ulai Health LLC"
        ],
        "product_ndc": [
          "73057-347"
        ],
        "product_type": [
          "HUMAN OTC DRUG"
        ],
        "route": [
          "ORAL"
        ],
        "substance_name": [
          "DIPHENHYDRAMINE HYDROCHLORIDE"
        ],
        "rxcui": [
          "1020477"
        ],
        "spl_id": [
          "2c2777c1-a456-d152-e063-6294a90a7539"
        ],
        "spl_set_id": [
          "135293fb-5674-4638-be55-b968cf51257e"
        ],
        "package_ndc": [
          "73057-347-11",
          "73057-347-08"
        ],
        "is_original_packager": [
          true
        ],
        "upc": [
          "0373057347115"
        ],
        "unii": [
          "TC2D6JAD40"
        ]
      }
    }
  ]
}