{
  "schema_version": 1,
  "kind": "drug_profile",
  "generic": "salbutamol",
  "review_status": "reviewed",
  "origin": "openfda",
  "sections": {
    "adult": [
      {
        "text": "For oral inhalation only Treatment or prevention of bronchospasm in adults and children 4 years of age and older: 2 inhalations every 4 to 6 hours. In some patients, one inhalation every 4 hours may be sufficient. ( 2.1 ) Prevention of exercise-induced bronchospasm in adults and children 4 years of age and older: 2 inhalations 15 to 30 minutes before exercise.",
        "source": "US FDA label for albuterol (Albuterol Sulfate Inhalation), section 'dosage and administration', retrieved 2026-08-29",
        "cached_file": "labels/salbutamol.json",
        "verbatim": true
      }
    ],
    "child": [
      {
        "text": "For oral inhalation only Treatment or prevention of bronchospasm in adults and children 4 years of age and older: 2 inhalations every 4 to 6 hours. In some patients, one inhalation every 4 hours may be sufficient. ( 2.1 ) Prevention of exercise-induced bronchospasm in adults and children 4 years of age and older: 2 inhalations 15 to 30 minutes before exercise.",
        "source": "US FDA label for albuterol (Albuterol Sulfate Inhalation), section 'dosage and administration', retrieved 2026-08-29",
        "cached_file": "labels/salbutamol.json",
        "verbatim": true
      },
      {
        "text": "The safety and effectiveness of Albuterol Sulfate Inhalation Aerosol for treatment of exercise-induced bronchospasm in children 12 years of age and older is based on one single-dose crossover study in 24 adults and adolescents with exercise-induced bronchospasm comparing doses of 180 mcg with placebo [see Clinical Studies ( 14.2 )] .",
        "source": "US FDA label for albuterol (Albuterol Sulfate Inhalation), section 'pediatric use', retrieved 2026-08-29",
        "cached_file": "labels/salbutamol.json",
        "verbatim": true
      },
      {
        "text": "The safety of Albuterol Sulfate Inhalation Aerosol in children 4 to 11 years of age is based on one 3-week clinical trial in 50 patients 4 to 11 years of age with asthma using the same formulation of albuterol as in Albuterol Sulfate Inhalation Aerosol comparing doses of 180 mcg four times daily with placebo.",
        "source": "US FDA label for albuterol (Albuterol Sulfate Inhalation), section 'pediatric use', retrieved 2026-08-29",
        "cached_file": "labels/salbutamol.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 albuterol (Albuterol Sulfate Inhalation), retrieved 2026-08-29",
        "cached_file": "labels/salbutamol.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 albuterol (Albuterol Sulfate Inhalation), retrieved 2026-08-29",
        "cached_file": "labels/salbutamol.json",
        "verbatim": false
      }
    ],
    "pregnancy": [
      {
        "text": "Pregnancy Exposure Registry There is a pregnancy exposure registry that monitors pregnancy outcomes in women exposed to asthma medications during pregnancy.",
        "source": "US FDA label for albuterol (Albuterol Sulfate Inhalation), section 'pregnancy', retrieved 2026-08-29",
        "cached_file": "labels/salbutamol.json",
        "verbatim": true
      },
      {
        "text": "For more information, contact the Mothers To Baby Pregnancy Studies conducted by the Organization of Teratology Information Specialists at 1-877-311-8972 or visit http://mothertobaby.org/pregnancy-studies/.",
        "source": "US FDA label for albuterol (Albuterol Sulfate Inhalation), section 'pregnancy', retrieved 2026-08-29",
        "cached_file": "labels/salbutamol.json",
        "verbatim": true
      },
      {
        "text": "Risk Summary There are no randomized clinical studies of use of albuterol during pregnancy.",
        "source": "US FDA label for albuterol (Albuterol Sulfate Inhalation), section 'pregnancy', retrieved 2026-08-29",
        "cached_file": "labels/salbutamol.json",
        "verbatim": true
      }
    ],
    "lactation": [
      {
        "text": "A study in which pregnant rats were dosed with radiolabeled albuterol sulfate demonstrated that drug-related material is transferred from the maternal circulation to the fetus. 8.2 Lactation Risk Summary There are no available data on the presence of albuterol in human milk, the effects on the breastfed child, or the effects on milk production.",
        "source": "US FDA label for albuterol (Albuterol Sulfate Inhalation), section 'use in specific populations', retrieved 2026-08-29",
        "cached_file": "labels/salbutamol.json",
        "verbatim": true
      },
      {
        "text": "However, plasma levels of albuterol after inhaled therapeutic doses are low in humans, and if present in breast milk, albuterol has a low oral bioavailability [see Clinical Pharmacology (12) ] .",
        "source": "US FDA label for albuterol (Albuterol Sulfate Inhalation), section 'use in specific populations', retrieved 2026-08-29",
        "cached_file": "labels/salbutamol.json",
        "verbatim": true
      },
      {
        "text": "The developmental and health benefits of breastfeeding should be considered along with the mother’s clinical need for albuterol and any potential adverse effects on the breastfed child from albuterol or from the underlying maternal condition.",
        "source": "US FDA label for albuterol (Albuterol Sulfate Inhalation), section 'use in specific populations', retrieved 2026-08-29",
        "cached_file": "labels/salbutamol.json",
        "verbatim": true
      }
    ]
  }
}