Fexofenadine

Selected allergy products temporarily relieve hay-fever/upper-respiratory-allergy runny nose, sneezing, itchy/watery eyes and itchy nose/throat. Hives products reduce hives and associated itching; they do not prevent hives or allergic reactions. This profile excludes pseudoephedrine combination dosing.

Current FDA NDA021909 lists 30 mg ODT products Discontinued; the retrieved ODT Drug Facts are product-history reference. NDA021963 prescription suspension is also Discontinued. Its May2019 PI approved uncomplicated chronic idiopathic urticaria at 6 months to 6 years, distinct from current OTC allergy/hives ages. This does not establish current prescription supply or permit unsupervised infant use.

At age ≥ 12: selected 60 mg allergy tablet, one with water every 12 hours, maximum two (120 mg) in 24 hours; selected 180 mg allergy or Hives tablet, one with water daily, maximum one (180 mg). Do not combine these regimens. These tablets are not for use below 12; age ≥ 65 or kidney disease requires medical advice. No universal higher-dose hives algorithm is supplied.

Shake and measure only with the enclosed cup. Age ≥ 12: 10 mL (60 mg) every 12 hours, maximum 20 mL daily. Allergy suspension at ages 2 to < 12: 5 mL (30 mg) every 12 hours, maximum 10 mL daily; below 2 ask a doctor. Hives suspension at ages 6 to < 12 uses that same 5 mL schedule, but below 6 ask a doctor. Both ask for medical advice at age ≥ 65 or with kidney disease. Their different pediatric indication thresholds must be preserved.

Historical 30 mg ODT label: age ≥ 12, two tablets every 12 hours, maximum four daily; ages 6 to < 12, one every 12 hours, maximum two daily; below 6 do not use. Place on tongue on an empty stomach, with/without water, and use immediately after opening the individual blister. FDA current status is Discontinued; verify an available exact formulation/current directions before use rather than substitute an adult tablet.

The discontinued FDA May2019 suspension PI gives CIU at ages 2–6: 30 mg (5 mL) twice daily; ages 6 months to < 2: 15 mg (2.5 mL) twice daily. Renal-impairment starting doses for those bands are once daily instead. Its broader renal section describes adult starting 60 mg once daily and ages 2–11 starting 30 mg once daily. These are approved historical clinical references, not a current OTC infant or renal self-dosing instruction. Current OTC labels require clinician assessment; no numerical regimen is established below 6 months.

Use water, not fruit juice; avoid simultaneous aluminum/magnesium antacids. Follow the exact package, and do not double a missed dose to exceed its daily maximum. Hives products require medical review if no improvement after 3 days, hives last over 6 weeks, or lesions are bruised/blistered/nonitchy. Unknown cause warrants assessment rather than prolonged empiric escalation.

Known allergy to fexofenadine or the ingredients of the exact product. OTC product-specific “do not use” directions also restrict ages and use for preventing known-trigger hives; kidney disease is an ask-a-doctor dose warning rather than an ingredient allergy. Check the actual formulation’s ingredients.

The selected current OTC labels and historical FDA prescription PI have no boxed warning. The Hives severe-allergy/epinephrine warnings remain important.

Historical clinical trials report headache, back pain, dizziness and stomach discomfort; children also reported cough/respiratory symptoms/fever, and younger children vomiting, diarrhea or somnolence/fatigue. Serious hypersensitivity including angioedema/anaphylaxis is reported. Trial age groups/causality differ; “non-drowsy” is not a guarantee for every person. Overdose can cause dizziness, drowsiness or dry mouth: seek medical/Poison Help assessment, not a safe dose inferred from high-dose studies; hemodialysis removes little fexofenadine.

Aluminum/magnesium antacids taken close to fexofenadine reduce exposure; current labels prohibit simultaneous use but do not provide one universal spacing interval. Apple, orange and grapefruit juices can lower exposure; use water. Erythromycin/ketoconazole increased concentrations in studied adult regimens without observed extra adverse/QTc effects in those studies; this is not a blanket safety claim or permission to change doses independently.

Current allergy liquid provides OTC doses from age 2; current Hives liquid from age 6; current selected adult tablets from age 12. Younger children need clinical assessment. Discontinued ODT and historical prescription CIU directions are separately identified. Below 6 months safety/effectiveness were unestablished in the FDA PI. Current products direct adults ≥ 65 to ask a doctor, particularly because renal function can decline.

Current OTC labels ask for professional advice. The FDA May2019 PI reports published literature and pharmacovigilance pregnancy data had not identified a drug-associated major-birth-defect/miscarriage risk; this is limited evidence, not proof of no risk. Fexofenadine is present in human milk; infant-effect and milk-production data were unavailable. Discuss maternal need, alternatives and infant context.

Renal dysfunction increases exposure and half-life; current OTC products require clinician-selected dosing. Historical numeric renal starts are provided above as provenance. Hepatic-impairment PK in the FDA PI did not differ substantially from healthy subjects, with no numeric liver adjustment specified. Do not infer dialysis effectively treats overdose.

Fexofenadine is a selective peripheral H1 antagonist and active metabolite of terfenadine; it is not the same drug/product. FDA PI: suspension peak about 1 hour in healthy adult subjects, protein binding 60–70%, adult mean half-life about 14.4 hours and hepatic metabolism about 5%. Radiolabeled recovery about 80% feces/11% urine does not establish the absorbed fraction. Pediatric, renal and formulation values differ; do not assume all products have identical food instructions.

Follow nasal/ocular or hives symptom relief, treatment duration, sedation/dizziness, renal context and medication/juice/antacid use. Inspect atypical lesions and urgently assess systemic severe-allergy signs. No routine serum fexofenadine level or universal ECG schedule is specified by the selected labels.

Use the actual concentration/age/indication chart, shake suspension and wash/air-dry its cup. Do not combine 60 mg and 180 mg schedules or exceed the daily package maximum. Take with water and avoid simultaneous aluminum/magnesium antacids. Ask about kidney disease, age ≥ 65, pregnancy/breastfeeding and younger-child use. Carry prescribed epinephrine and seek emergency help for anaphylaxis; an antihistamine does not replace it.

Aurohealth OTC allergy tablet 60 mg: 30-tablet bottle NDC 58602-877-09. This identifies the selected package, not local stock; verify the original written label and ingredients.

Current selected OTC tablets: 60 and 180 mg; suspensions: 30 mg per 5 mL (6 mg/mL), with indication-dependent ages. FDA ANDA202039/ANDA213466 and selected Allegra Hives application records list OTC products. FDA NDA021909 ODT30 mg and NDA021963 older prescription suspension are Discontinued. Do not infer a current Rx infant bottle or equivalent pseudoephedrine combination.

Current selected products: 20–25°C; protect tablets from excessive moisture/light and follow seal/blister instructions. Shake suspension and use its supplied cup; wash/air-dry after use. Historical ODT instructions require immediate use after opening and no torn/open blister; this is not evidence of current availability. Keep children away and follow actual expiry.