Quick answers
- What is Loratadine used for?
- The FDA-approved label (Loratadine, Bryant Ranch Prepack, June 13, 2025) says: “USE(S) temporarily relieves these symptoms due to hay fever or other upper respiratory allergies: runny nose sneezing itchy, water eyes itching of the nose or throat” This page is not medical advice. Talk to your doctor or pharmacist before you start, stop or change any medicine.
- Does Loratadine have a boxed warning?
- No. None of the 2 FDA labels we found for this medicine has a boxed warning.
- Is there a shortage of Loratadine?
- No current shortage is listed by the FDA for the products of this medicine (FDA data from October 30, 2026).
- Has Loratadine been recalled?
- No recall linked to the products of this medicine appears in the FDA enforcement reports we use.
- Who makes Loratadine?
- 1 company lists prescription products of Loratadine in the FDA NDC Directory, including Bryant Ranch Prepack.
What Loratadine is used for
Quoted from the “Indications and Usage” section of the FDA-approved label.
USE(S) temporarily relieves these symptoms due to hay fever or other upper respiratory allergies: runny nose sneezing itchy, water eyes itching of the nose or throat
— FDA label: Loratadine, Bryant Ranch Prepack, effective June 13, 2025. Read the full label on DailyMed →
The FDA has 2 labels for products of this medicine (different makers and forms); uses can differ between them. Check the label that comes with your own medicine.
This page is not medical advice. Talk to your doctor or pharmacist before you start, stop or change any medicine.
Boxed warning
A boxed warning (“black box”) is the FDA’s strongest warning on a drug label, for serious or life-threatening risks.
The label quoted above has no boxed warning.
0 of 2 FDA labels for this medicine have a boxed warning.
Forms and how it is given
| Dosage forms | Tablet |
|---|---|
| Route | Oral |
| Prescription products | 2 in the FDA NDC Directory |
Companies that list this medicine
Labelers in the FDA NDC Directory: the company named on the package (maker or distributor), with the number of prescription products.
- Bryant Ranch Prepack2 products
FDA approval history
- ANDA: Abbreviated New Drug Application: how a generic version is approved.
Generic approvals (2)
- ANDA210722Granules · December 23, 2019
- ANDA211718Hetero Labs Ltd V · July 28, 2023
Shortage status
The FDA drug shortage list does not show these products.
Recalls
No recall linked to these products (by their NDC code) appears in the FDA enforcement reports.
Official identifiers
| RxCUI (RxNorm) | 311372 |
|---|---|
| SPL set ID of the quoted label | 0d74af21-3ef7-418b-a2ef-78737b0af288 |
| FDA labels (SPL) | 2 |
| FDA applications | 2 ANDA |
| Active ingredients (FDA) | LORATADINE |
Sources
- FDA-approved label on DailyMed (National Library of Medicine) — Loratadine, Bryant Ranch Prepack, effective June 13, 2025; via openFDA, FDA data exported October 30, 2026, retrieved October 31, 2026
- NDC Directory (openFDA) — U.S. Food and Drug Administration (FDA), FDA data exported October 30, 2026, retrieved October 31, 2026
- Drugs@FDA (openFDA) — U.S. Food and Drug Administration (FDA), FDA data exported October 30, 2026, retrieved October 31, 2026
- Drug recall enforcement reports (openFDA) — U.S. Food and Drug Administration (FDA), FDA data exported October 27, 2026, retrieved October 31, 2026
- Drug shortages (openFDA) — U.S. Food and Drug Administration (FDA), FDA data exported October 30, 2026, retrieved October 31, 2026
openFDA data is provided by the FDA as is; it may be incomplete. Always rely on the label that comes with your medicine. FDA Enforcement Report search →