Drug label · Respiratory & allergy
Allergy — Fexofenadine Hydrochloride drug label
openFDA · Retrieved 2026-10-13
Allergy label record for fexofenadine hydrochloride. The label lists Amazon.com Services LLC as labeler/manufacturer. Route: oral. Includes selected complete prescribing-information sections from openFDA; consult the linked original label for the complete document.
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Reference details
- Brand name
- ALLERGY
- Generic name
- FEXOFENADINE HYDROCHLORIDE
- Active substance
- FEXOFENADINE HYDROCHLORIDE
- Labeler / manufacturer listed
- Amazon.com Services LLC
- Route
- ORAL
- Product type
- HUMAN OTC DRUG
- Application number
- ANDA212971
- Label version
- 3
- SPL set ID
- 1b5aa481-205d-4935-ae58-fcb8cbc35c4c
- Label effective date
- 2026-09-09
- openFDA dataset updated
- 2026-10-13
Indications and usage
Uses temporarily relieves these symptoms due to hay fever or other upper respiratory allergies: • runny nose • itchy, watery eyes • sneezing • itching of the nose or throat
Purpose
Purpose Antihistamine
Warnings
Warnings Do not use if you have ever had an allergic reaction to this product or any of its ingredients. Ask a doctor before use if you have kidney disease. Your doctor should determine if you need a different dose. When using this product • do not take more than directed • do not take at the same time as aluminum or magnesium antacids • do not take with fruit juices (see Directions) Stop use and ask a doctor if an allergic reaction to this product occurs. Seek medical help right away. If pregnant or breast-feeding, ask a health professional before use. Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center right away (1-800-222-1222).
Do not use
Do not use if you have ever had an allergic reaction to this product or any of its ingredients.
Ask doctor
Ask a doctor before use if you have kidney disease. Your doctor should determine if you need a different dose.
When using
When using this product • do not take more than directed • do not take at the same time as aluminum or magnesium antacids • do not take with fruit juices (see Directions)
Stop use
Stop use and ask a doctor if an allergic reaction to this product occurs. Seek medical help right away.
Dosage and administration
Directions adults and children 12 years of age and over take one 180 mg tablet with water once a day; do not take more than 1 tablet in 24 hours children under 12 years of age do not use adults 65 years of age and older ask a doctor consumers with kidney disease ask a doctor
Pregnancy or breast feeding
If pregnant or breast-feeding, ask a health professional before use.
Keep out of reach of children
Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center right away (1-800-222-1222).
Active ingredient
Active ingredient (in each tablet) Fexofenadine HCl 180 mg
Inactive ingredient
Inactive ingredients colloidal silicon dioxide, croscarmellose sodium, FD&C blue #2 aluminum lake, FD&C red #40 aluminum lake, FD&C yellow #6 aluminum lake, lactose monohydrate, magnesium stearate, microcrystalline cellulose, polyethylene glycol, polyvinyl alcohol, pregelatinized starch, talc, titanium dioxide
Storage and handling
Other information • do not use if printed foil under cap is broken or missing • store between 20° -25°C (68° -77°F) • protect from excessive moisture • this product meets the requirements of USP Dissolution Test 2
Sources and reuse
Selected source label sections. Check the original for the complete label, formatting and latest version.
Selected complete plain-text label sections. Tables and images may require consulting the linked original label. This is a reference copy, not prescribing advice.
Source date: 2026-09-09. Retrieved: 2026-10-13. Text has been organized for reading; this import has not been independently reviewed by a clinician. It is not individualized medical advice.