{
  "schema_version": 1,
  "kind": "drug_profile",
  "generic": "amoxicillin",
  "review_status": "reviewed",
  "origin": "openfda",
  "sections": {
    "adult": [
      {
        "text": "In Adults, 750 to 1750 mg/day in divided doses every 8 to 12 hours.",
        "source": "US FDA label for amoxicillin (Amoxicillin), section 'dosage and administration', retrieved 2026-08-29",
        "cached_file": "labels/amoxicillin.json",
        "verbatim": true
      },
      {
        "text": "( 2.3 ) Dosing for H. pylori Infection (in Adults): Triple therapy: 1 gram amoxicillin, 500 mg clarithromycin, and 30 mg lansoprazole, all given twice daily (every 12 hours) for 14 days.",
        "source": "US FDA label for amoxicillin (Amoxicillin), section 'dosage and administration', retrieved 2026-08-29",
        "cached_file": "labels/amoxicillin.json",
        "verbatim": true
      },
      {
        "text": "Dual therapy: 1 gram amoxicillin and 30 mg lansoprazole, each given three times daily (every 8 hours) for 14 days.",
        "source": "US FDA label for amoxicillin (Amoxicillin), section 'dosage and administration', retrieved 2026-08-29",
        "cached_file": "labels/amoxicillin.json",
        "verbatim": true
      }
    ],
    "child": [
      {
        "text": "The safety and effectiveness of amoxicillin for the treatment of upper respiratory tract infections, and infections of the genitourinary tract, skin and skin structure and lower respiratory tract have been established in pediatric patients. The safety and effectiveness of amoxicillin for the treatment of H. Pylori infection have not been established in pediatric patients.",
        "source": "US FDA label for amoxicillin (Amoxicillin), section 'pediatric use', retrieved 2026-08-29",
        "cached_file": "labels/amoxicillin.json",
        "verbatim": true
      },
      {
        "text": "In Adults, 750 to 1750 mg/day in divided doses every 8 to 12 hours. In Pediatric Patients over 3 Months of Age, 20 to 45 mg/kg/day in divided doses every 8 to 12 hours. Refer to full prescribing information for specific dosing regimens. ( 2.2 , 2.3 ) The upper dose for neonates and infants aged 3 months or younger is 30 mg/kg/day divided every 12 hours. ( 2.3 ) Dosing for H.",
        "source": "US FDA label for amoxicillin (Amoxicillin), section 'dosage and administration', retrieved 2026-08-29",
        "cached_file": "labels/amoxicillin.json",
        "verbatim": true
      },
      {
        "text": "In Pediatric Patients over 3 Months of Age, 20 to 45 mg/kg/day in divided doses every 8 to 12 hours.",
        "source": "US FDA label for amoxicillin (Amoxicillin), section 'dosage and administration', retrieved 2026-08-29",
        "cached_file": "labels/amoxicillin.json",
        "verbatim": true
      }
    ],
    "renal": [
      {
        "text": "( 2.4 ) Reduce the dose in patients with severe renal impairment (GFR greater than 30 mL/min).",
        "source": "US FDA label for amoxicillin (Amoxicillin), section 'dosage and administration', retrieved 2026-08-29",
        "cached_file": "labels/amoxicillin.json",
        "verbatim": true
      },
      {
        "text": "Please refer to clarithromycin and lansoprazole full prescribing information. 2.5 Dosage in Renal Impairment for Adults and Pediatric Patients Aged 3 Months and Older and Weight Greater than 40 kg Patients with impaired renal function do not generally require a reduction in dose unless the impairment is severe.",
        "source": "US FDA label for amoxicillin (Amoxicillin), section 'dosage and administration', retrieved 2026-08-29",
        "cached_file": "labels/amoxicillin.json",
        "verbatim": true
      },
      {
        "text": "Renal impairment patients with a glomerular filtration rate of less than 30 mL/min should NOT receive the 875 mg dose.",
        "source": "US FDA label for amoxicillin (Amoxicillin), section 'dosage and administration', retrieved 2026-08-29",
        "cached_file": "labels/amoxicillin.json",
        "verbatim": true
      }
    ],
    "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 amoxicillin (Amoxicillin), retrieved 2026-08-29",
        "cached_file": "labels/amoxicillin.json",
        "verbatim": false
      }
    ],
    "pregnancy": [
      {
        "text": "Teratogenic Effects : Pregnancy Category B.",
        "source": "US FDA label for amoxicillin (Amoxicillin), section 'pregnancy', retrieved 2026-08-29",
        "cached_file": "labels/amoxicillin.json",
        "verbatim": true
      },
      {
        "text": "Reproduction studies have been performed in mice and rats at doses up to 2000 mg/kg (3 and 6 times the 3 g human dose, based on body surface area).",
        "source": "US FDA label for amoxicillin (Amoxicillin), section 'pregnancy', retrieved 2026-08-29",
        "cached_file": "labels/amoxicillin.json",
        "verbatim": true
      },
      {
        "text": "There was no evidence of harm to the fetus due to amoxicillin.",
        "source": "US FDA label for amoxicillin (Amoxicillin), section 'pregnancy', retrieved 2026-08-29",
        "cached_file": "labels/amoxicillin.json",
        "verbatim": true
      }
    ],
    "lactation": [
      {
        "text": "Penicillins have been shown to be excreted in human milk.",
        "source": "US FDA label for amoxicillin (Amoxicillin), section 'nursing mothers', retrieved 2026-08-29",
        "cached_file": "labels/amoxicillin.json",
        "verbatim": true
      },
      {
        "text": "Amoxicillin use by nursing mothers may lead to sensitization of infants.",
        "source": "US FDA label for amoxicillin (Amoxicillin), section 'nursing mothers', retrieved 2026-08-29",
        "cached_file": "labels/amoxicillin.json",
        "verbatim": true
      },
      {
        "text": "Caution should be exercised when amoxicillin is administered to a nursing woman.",
        "source": "US FDA label for amoxicillin (Amoxicillin), section 'nursing mothers', retrieved 2026-08-29",
        "cached_file": "labels/amoxicillin.json",
        "verbatim": true
      }
    ]
  },
  "verdicts": {
    "lactation": {
      "level": "caution",
      "line": "The label allows it only when the benefit is judged to outweigh the risk. Read the quote below.",
      "set_by": "Set from the label's own words, not from a reading of them: 'Caution should be exercised when amoxicillin is administered to a nursing'."
    }
  }
}