{
  "schema_version": 1,
  "kind": "drug_profile",
  "generic": "mebendazole",
  "review_status": "reviewed",
  "origin": "openfda",
  "sections": {
    "adult": [
      {
        "text": "The recommended dosage in patients one year of age and older is one VERMOX™ CHEWABLE 500 mg tablet taken as a single dose.",
        "source": "US FDA label for mebendazole (VERMOX), section 'dosage and administration', retrieved 2026-08-29",
        "cached_file": "labels/mebendazole.json",
        "verbatim": true
      },
      {
        "text": "The recommended dosage in patients one year of age and older is one single tablet of VERMOX™ CHEWABLE 500 mg taken as a single dose, chewed completely before swallowing ( 2 ).",
        "source": "US FDA label for mebendazole (VERMOX), section 'dosage and administration', retrieved 2026-08-29",
        "cached_file": "labels/mebendazole.json",
        "verbatim": true
      },
      {
        "text": "The recommended dosage in patients one year of age and older is one VERMOX™ CHEWABLE 500 mg tablet taken as a single dose. Chew VERMOX™ CHEWABLE 500 mg tablet completely before swallowing. Do not swallow the tablet whole. For patients who have difficulty chewing the tablet, approximately 2 mL to 3 mL of drinking water can be added to a suitably sized spoon and the VERMOX™ CHEWABLE 500 mg tablet placed into the water.",
        "source": "US FDA label for mebendazole (VERMOX), section 'dosage and administration', retrieved 2026-08-29",
        "cached_file": "labels/mebendazole.json",
        "verbatim": true
      }
    ],
    "child": [
      {
        "text": "The safety and effectiveness of VERMOX™ CHEWABLE 500 mg tablets have been established in pediatric patients 1 to 16 years of age. Use of VERMOX™ CHEWABLE 500 mg tablets in children is supported by evidence from adequate and well-controlled studies of VERMOX™ CHEWABLE 500 mg tablets [see Clinical Studies (14) ] .",
        "source": "US FDA label for mebendazole (VERMOX), section 'pediatric use', retrieved 2026-08-29",
        "cached_file": "labels/mebendazole.json",
        "verbatim": true
      }
    ],
    "renal": [
      {
        "text": "No kidney-impairment dose in this label. Not a statement that none is needed.",
        "source": "Read and found silent: the US FDA label for mebendazole (VERMOX), retrieved 2026-08-29",
        "cached_file": "labels/mebendazole.json",
        "verbatim": false
      }
    ],
    "hepatic": [
      {
        "text": "No liver-impairment dose in this label. Not a statement that none is needed.",
        "source": "Read and found silent: the US FDA label for mebendazole (VERMOX), retrieved 2026-08-29",
        "cached_file": "labels/mebendazole.json",
        "verbatim": false
      }
    ],
    "pregnancy": [
      {
        "text": "Risk Summary The available published literature on mebendazole use in pregnant women has not reported a clear association between mebendazole and a potential risk of major birth defects or miscarriages [see Data ].",
        "source": "US FDA label for mebendazole (VERMOX), section 'pregnancy', retrieved 2026-08-29",
        "cached_file": "labels/mebendazole.json",
        "verbatim": true
      },
      {
        "text": "There are risks to the mother and fetus associated with untreated helminthic infection during pregnancy [see Clinical Considerations ] .",
        "source": "US FDA label for mebendazole (VERMOX), section 'pregnancy', retrieved 2026-08-29",
        "cached_file": "labels/mebendazole.json",
        "verbatim": true
      },
      {
        "text": "In animal reproduction studies, adverse developmental effects (i.e., skeletal malformations, soft tissue malformations, decreased pup weight, embryolethality) were observed when mebendazole was administered to pregnant rats during the period of organogenesis at single oral doses as low as 10 mg/kg (approximately 0.2-fold the maximum recommended human dose (MRHD)).",
        "source": "US FDA label for mebendazole (VERMOX), section 'pregnancy', retrieved 2026-08-29",
        "cached_file": "labels/mebendazole.json",
        "verbatim": true
      }
    ],
    "lactation": [
      {
        "text": "No abnormalities were found on gross and radiographic examination of pups at birth. 8.2 Lactation Risk Summary Limited data from case reports demonstrate that a small amount of mebendazole is present in human milk following oral administration.",
        "source": "US FDA label for mebendazole (VERMOX), section 'use in specific populations', retrieved 2026-08-29",
        "cached_file": "labels/mebendazole.json",
        "verbatim": true
      },
      {
        "text": "There are no reports of effects on the breastfed infant, and the limited reports on the effects on milk production are inconsistent.",
        "source": "US FDA label for mebendazole (VERMOX), section 'use in specific populations', retrieved 2026-08-29",
        "cached_file": "labels/mebendazole.json",
        "verbatim": true
      },
      {
        "text": "The limited clinical data during lactation precludes a clear determination of the risk of VERMOX™ CHEWABLE to a breastfed infant; therefore, developmental and health benefits of breastfeeding should be considered along with the mother's clinical need for VERMOX™ CHEWABLE and any potential adverse effects on the breastfed infant from VERMOX™ CHEWABLE or from the underlying maternal condition.",
        "source": "US FDA label for mebendazole (VERMOX), section 'use in specific populations', retrieved 2026-08-29",
        "cached_file": "labels/mebendazole.json",
        "verbatim": true
      }
    ]
  }
}