Drugplain

Claritin 10 mg/1

Loratadine · TABLET · Bayer HealthCare LLC.

2 Recalls on Record
Plain English

Claritin (loratadine) is an over-the-counter antihistamine tablet taken by mouth that helps relieve allergy symptoms like sneezing, itching, and runny nose. It is commonly used to manage seasonal and year-round allergies.

Key Facts

Brand Name
Claritin
Generic Name
Loratadine
NDC Code (Product)
11523-4359
Manufacturer
Bayer HealthCare LLC.
Strength
10 mg/1
Dosage Form
TABLET
Route
ORAL
Marketing Status
Application #
NDA019658
Marketing Start
04/12/1993

Recall History

2 Recalls on Record
Class II06/23/2022

Family Dollar Stores, Llc.

CGMP Deviations: product held outside appropriate storage temperature conditions.

OngoingVoluntary: Firm initiated
Class II12/26/2025

GOLD STAR DISTRIBUTION INC

CGMP Deviations: Insanitary conditions including rodent exposure/activity in their distribution center.

OngoingVoluntary: Firm initiated

Side Effects Reported to FDA

FDA FAERS database · These are reported events, not confirmed side effects

drug ineffective14,090 reports
fatigue6,584 reports
nausea5,858 reports
headache5,416 reports
dyspnoea4,821 reports
diarrhoea4,783 reports
off label use4,688 reports
dizziness4,486 reports
pain4,065 reports
rash3,423 reports

Full Prescribing Information

Source: FDA Drug Label (SPL)For healthcare professionals

Indications & 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

Dosage & Administration

Directions chew or crush tablets completely before swallowing. adults and children 6 years and over chew 2 tablets daily; not more than 2 chewable tablets in 24 hours children 2 to under 6 years of age chew 1 tablet daily; not more than 1 chewable tablet in 24 hours children under 2 years of age ask a doctor consumers with liver or kidney disease ask a doctor

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 liver or kidney disease. Your doctor should determine if you need a different dose. When using this product do not take more than directed. Taking more than directed may cause drowsiness. 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.

Frequently Asked Questions

What is Claritin used for?

Claritin (loratadine) is an over-the-counter antihistamine tablet taken by mouth that helps relieve allergy symptoms like sneezing, itching, and runny nose. It is commonly used to manage seasonal and year-round allergies.

Is Claritin a controlled substance?

Claritin is not classified as a controlled substance by the DEA.

What is the generic name for Claritin?

The generic name for Claritin is Loratadine. There are 10 other brand versions of Loratadine.

What is the NDC code for Claritin 10 mg/1?

The NDC (National Drug Code) for Claritin 10 mg/1 is 11523-4359, listed by Bayer HealthCare LLC..

Product NDC

11523-4359

Package NDC

11523-4359-1

Other Loratadine Brands

See all →

Not medical advice. Always consult your doctor or pharmacist before making any medication decisions.

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