3c9ad1f8-e8ef-bcd0-e063-6394a90ac20e

SPL v2

SPL

SPL Set ID 3c9ad1f8-e8ef-bcd0-e063-6394a90ac20e

Route

oral

Published

Effective Date 2025-12-28

Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients

loratadine (10 mg)

Inactive Ingredients

lactose monohydrate microcrystalline cellulose magnesium stearate sodium starch glycolate type a corn

Identifiers & Packaging

Pill Appearance

Imprint: Claritin;10;458 Shape: round Color: white Size: 10 mm Score: 1

Marketing Status

anda active Since 2020-12-01

Description

Drug Facts

Medication Information

Active Ingredient

Active ingredient (in each tablet)

Loratadine, 10 mg USP

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

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

Other Information

■ store at 20º -25º C (68º -77º F) (see USP Controlled Room Temperature)

Description

Drug Facts

Section 42229-5

Drug Facts

Section 50570-1

Do not useif you have ever had an allergic reaction to this product or any of its ingredients.

Section 51727-6

Inactive ingredients lactose monohydrate, magnesium stearate, microcrystalline cellulose, sodium starch glycolate

Section 51945-4

Section 53413-1

Questions or comments?

1-800-CLARITIN (1-800-252-7484) or www.claritin.com

Section 55105-1

Purpose

Antihistamine

Stop Use

Stop use and ask a doctor ifan allergic reaction to this product occurs. Seek medical help right away.

Claritin 25

Ask A Doctor

Ask a doctor before use if you haveliver or kidney disease. Your doctor should determine if you need a different dose.

Claritin 1 Pouch

When Using This Product

When using this productdo not take more than directed. Taking more than directed may cause drowsiness.

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).

Structured Label Content

Active Ingredient (55106-9)

Active ingredient (in each tablet)

Loratadine, 10 mg USP

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

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

Other Information (Other information)

■ store at 20º -25º C (68º -77º F) (see USP Controlled Room Temperature)

Section 42229-5 (42229-5)

Drug Facts

Section 50570-1 (50570-1)

Do not useif you have ever had an allergic reaction to this product or any of its ingredients.

Section 51727-6 (51727-6)

Inactive ingredients lactose monohydrate, magnesium stearate, microcrystalline cellulose, sodium starch glycolate

Section 51945-4 (51945-4)

Section 53413-1 (53413-1)

Questions or comments?

1-800-CLARITIN (1-800-252-7484) or www.claritin.com

Section 55105-1 (55105-1)

Purpose

Antihistamine

Stop Use (Stop use)

Stop use and ask a doctor ifan allergic reaction to this product occurs. Seek medical help right away.

Claritin 25 (claritin 25)

Ask A Doctor (Ask a doctor)

Ask a doctor before use if you haveliver or kidney disease. Your doctor should determine if you need a different dose.

Claritin 1 Pouch (Claritin 1 pouch)

When Using This Product (When using this product)

When using this productdo not take more than directed. Taking more than directed may cause drowsiness.

If Pregnant 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).

Advanced Ingredient Data

[{"name": "LACTOSE MONOHYDRATE", "unii": "EWQ57Q8I5X", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "MICROCRYSTALLINE CELLULOSE", "unii": "OP1R32D61U", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "MAGNESIUM STEARATE", "unii": "70097M6I30", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "SODIUM STARCH GLYCOLATE TYPE A CORN", "unii": "AG9B65PV6B", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "LORATADINE", "unii": "7AJO3BO7QN", "classCode": "ACTIB", "strengthNumerator": "10", "strengthDenominator": "1", "strengthNumeratorUnit": "mg", "strengthDenominatorUnit": "1"}]

Raw Label Data

All Sections (JSON)

{"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", "42229-5": "Drug Facts", "50570-1": "Do not use if you have ever had an allergic reaction to this product or any of its ingredients.", "51727-6": "Inactive ingredients lactose monohydrate, magnesium stearate, microcrystalline cellulose, sodium starch glycolate", "53413-1": "Questions or comments? 1-800-CLARITIN (1-800-252-7484) or www.claritin.com", "55105-1": "Purpose Antihistamine", "55106-9": "Active ingredient (in each tablet) Loratadine, 10 mg USP", "Stop use": "Stop use and ask a doctor if an allergic reaction to this product occurs. Seek medical help right away.", "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", "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.", "Other information": "■ store at 20º -25º C (68º -77º F) (see USP Controlled Room Temperature)", "When using this product": "When using this product do not take more than directed. Taking more than directed may cause drowsiness.", "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)."}

Additional Information

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Source: dailymed · Ingested: 2026-02-15T12:07:55.651478 · Updated: 2026-03-14T23:11:56.566307