Drug label · Respiratory & allergy
Claritin — Loratadine drug label
openFDA · Retrieved 2026-10-13
Claritin label record for loratadine. The label lists Select Consumer Group 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
- Claritin
- Generic name
- LORATADINE
- Active substance
- LORATADINE
- Labeler / manufacturer listed
- Select Consumer Group
- Route
- ORAL
- Product type
- HUMAN OTC DRUG
- Application number
- ANDA075209
- Label version
- 2
- SPL set ID
- 3c9ad1f8-e8ef-bcd0-e063-6394a90ac20e
- Label effective date
- 2025-12-28
- 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 ■ sneezing ■ itchy, watery eyes ■ 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 Ask a doctor before use if you have liver or kidney disease. Your doctor should determine if you need a different dose. When using this product When using this product do not take more than directed. Taking more than directed may cause drowsiness. Stop use Stop use and ask a doctor if an allergic reaction to this product occurs. Seek medical help right away. If pregnant 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).
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 Ask a doctor before use if you have liver or kidney disease. Your doctor should determine if you need a different dose.
When using
When using this product When using this product do not take more than directed. Taking more than directed may cause drowsiness.
Stop use
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 Directions adults and children 6 years and over 1 tablet daily; not more than 1 tablet in 24 hours children under 6 years of age ask a doctor consumers with liver or kidney disease ask a doctor
Pregnancy or breast feeding
If pregnant 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 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) Loratadine, 10 mg USP
Inactive ingredient
Inactive ingredients lactose monohydrate, magnesium stearate, microcrystalline cellulose, sodium starch glycolate
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: 2025-12-28. 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.