{
  "schema_version": 1,
  "kind": "drug_profile",
  "generic": "meclizine",
  "review_status": "reviewed",
  "origin": "openfda",
  "sections": {
    "adult": [
      {
        "text": "Recommended dosage: 25 mg to 100 mg daily, in divided doses ( 2.1 ).",
        "source": "US FDA label for meclizine (Meclizine Hydrochloride), section 'dosage and administration', retrieved 2026-08-29",
        "cached_file": "labels/meclizine.json",
        "verbatim": true
      },
      {
        "text": "Chewable Tablets: Must be chewed or crushed before swallowing; do not swallow whole ( 2.2 ). 2.1 Recommended Dosage The recommended dosage is 25 mg to 100 mg daily administered orally, in divided doses, depending upon clinical response. 2.2 Administration Instructions Tablets Meclizine hydrochloride tablets must be swallowed whole.",
        "source": "US FDA label for meclizine (Meclizine Hydrochloride), section 'dosage and administration', retrieved 2026-08-29",
        "cached_file": "labels/meclizine.json",
        "verbatim": true
      },
      {
        "text": "Recommended dosage: 25 mg to 100 mg daily, in divided doses ( 2.1 ). Tablets: Swallow whole ( 2.2 ). Chewable Tablets: Must be chewed or crushed before swallowing; do not swallow whole ( 2.2 ). 2.1 Recommended Dosage The recommended dosage is 25 mg to 100 mg daily administered orally, in divided doses, depending upon clinical response. 2.2 Administration Instructions Tablets Meclizine hydrochloride tablets must be swallowed whole.",
        "source": "US FDA label for meclizine (Meclizine Hydrochloride), section 'dosage and administration', retrieved 2026-08-29",
        "cached_file": "labels/meclizine.json",
        "verbatim": true
      }
    ],
    "child": [
      {
        "text": "Safety and effectiveness in pediatric patients have not been established.",
        "source": "US FDA label for meclizine (Meclizine Hydrochloride), section 'pediatric use', retrieved 2026-08-29",
        "cached_file": "labels/meclizine.json",
        "verbatim": true
      }
    ],
    "renal": [
      {
        "text": "Treatment with meclizine hydrochloride should be administered with caution in patients with hepatic impairment. 8.7 Renal Impairment The effect of renal impairment on the pharmacokinetics of meclizine has not been evaluated.",
        "source": "US FDA label for meclizine (Meclizine Hydrochloride), section 'use in specific populations', retrieved 2026-08-29",
        "cached_file": "labels/meclizine.json",
        "verbatim": true
      },
      {
        "text": "Because of a potential for drug/metabolite accumulation, meclizine hydrochloride should be administered with caution in patients with renal impairment and in the elderly, as renal function generally declines with age. 8.8 Genetic CYP2D6 Polymorphism The genetic polymorphism of CYP2D6 that results in poor-, intermediate-, extensive-, and ultrarapid metabolizer phenotypes could contribute to large inter-individual variability in meclizine exposure.",
        "source": "US FDA label for meclizine (Meclizine Hydrochloride), section 'use in specific populations', retrieved 2026-08-29",
        "cached_file": "labels/meclizine.json",
        "verbatim": true
      }
    ],
    "hepatic": [
      {
        "text": "The developmental and health benefits of breastfeeding should be considered along with the mother’s clinical need for meclizine hydrochloride and any potential adverse effects on the breastfed infant from meclizine hydrochloride or from the underlying maternal condition. 8.4 Pediatric Use Safety and effectiveness in pediatric patients have not been established.",
        "source": "US FDA label for meclizine (Meclizine Hydrochloride), section 'use in specific populations', retrieved 2026-08-29",
        "cached_file": "labels/meclizine.json",
        "verbatim": true
      },
      {
        "text": "As meclizine hydrochloride undergoes metabolism, hepatic impairment may result in increased systemic exposure of meclizine.",
        "source": "US FDA label for meclizine (Meclizine Hydrochloride), section 'use in specific populations', retrieved 2026-08-29",
        "cached_file": "labels/meclizine.json",
        "verbatim": true
      },
      {
        "text": "Treatment with meclizine hydrochloride should be administered with caution in patients with hepatic impairment. 8.7 Renal Impairment The effect of renal impairment on the pharmacokinetics of meclizine has not been evaluated.",
        "source": "US FDA label for meclizine (Meclizine Hydrochloride), section 'use in specific populations', retrieved 2026-08-29",
        "cached_file": "labels/meclizine.json",
        "verbatim": true
      }
    ],
    "pregnancy": [
      {
        "text": "Risk Summary Data from epidemiological studies have not generally indicated a drug-associated risk of major birth defects with meclizine during pregnancy.",
        "source": "US FDA label for meclizine (Meclizine Hydrochloride), section 'pregnancy', retrieved 2026-08-29",
        "cached_file": "labels/meclizine.json",
        "verbatim": true
      },
      {
        "text": "However, in a published study, an increased incidence of fetal malformations was observed following oral administration of meclizine to pregnant rats during the period of organogenesis, at doses similar to those used clinically.",
        "source": "US FDA label for meclizine (Meclizine Hydrochloride), section 'pregnancy', retrieved 2026-08-29",
        "cached_file": "labels/meclizine.json",
        "verbatim": true
      },
      {
        "text": "In the U.S. general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2-4% and 15-20%, respectively.",
        "source": "US FDA label for meclizine (Meclizine Hydrochloride), section 'pregnancy', retrieved 2026-08-29",
        "cached_file": "labels/meclizine.json",
        "verbatim": true
      }
    ],
    "lactation": [
      {
        "text": "These effects occurred at doses as low as 25 mg/kg, which is approximately 2 times the maximum recommended human dose (100 mg) on a body surface area (mg/m2) basis. 8.2 Lactation Risk Summary There are no data on the presence of meclizine in human milk, the effects on the breastfed infant, or the effects on milk production.",
        "source": "US FDA label for meclizine (Meclizine Hydrochloride), section 'use in specific populations', retrieved 2026-08-29",
        "cached_file": "labels/meclizine.json",
        "verbatim": true
      },
      {
        "text": "The developmental and health benefits of breastfeeding should be considered along with the mother’s clinical need for meclizine hydrochloride and any potential adverse effects on the breastfed infant from meclizine hydrochloride or from the underlying maternal condition. 8.4 Pediatric Use Safety and effectiveness in pediatric patients have not been established.",
        "source": "US FDA label for meclizine (Meclizine Hydrochloride), section 'use in specific populations', retrieved 2026-08-29",
        "cached_file": "labels/meclizine.json",
        "verbatim": true
      }
    ]
  }
}