Drug Facts

Drug Facts

SPL v4

SPL

SPL Set ID a34e8cb7-4fdf-45be-b288-45d93eef6220

Route

ORAL

Published

Effective Date 2022-12-26

Document Type 34390-5 HUMAN OTC DRUG LABEL

Composition & Product

Active Ingredients

Loratadine (10 mg)

Inactive Ingredients

Lactose Monohydrate Magnesium Stearate Starch, Corn

Identifiers & Packaging

Pill Appearance

Imprint: 458;Claritin;10 Shape: round Color: white Size: 6 mm Score: 1

Marketing Status

NDA Active Since 2021-03-01

Description

Active ingredients (in each tablet) Purpose Loratadine 10 mg Antihistamine

Medication Information

Description

Active ingredients (in each tablet) Purpose Loratadine 10 mg Antihistamine

Use

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

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 productdon not take more than directed. Taking more than directed may cause drowsiness.

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

If pregnant or breast-feeding,ask 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.

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
consumer with liver or kidney disease	ask a doctor

Claritin ®

Active ingredients (in each tablet)	Purpose
Loratadine 10 mg	Antihistamine

Other Information

Safety sealed: do not use if the individual blister unit imprinted with Claritin ^®is open or torn
Store between 20 ^o to 25 ^{o C}(68 ^oto 77 ^oF)
Protect from excessive moisture

Inactive Ingredients

Corn starch, lactose monohydrate, magnesium stearate

Questions and Comments?

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

Dist. by: Bayer HealthCare LLC

Whippany, NJ 07981

Product of India

Do not use if pouch is torn or broken.

Repackaged and distributed by:

RJ General

2024 Northwest Drive

Cincinnati OH 45231

Principal Display Panel 25 Tablet Pouch Carton

Non-Drowsy*

Claritin ^®

loratadine tablets 10 mg/ antihistamine

Indoor & Outdoor Allergies

Relief of:

runny nose
itchy, watery eyes
sneezing
itching of the throat or nose

Structured Label Content

Use (USE)

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

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 productdon not take more than directed. Taking more than directed may cause drowsiness.

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

If pregnant or breast-feeding,ask 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.

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
consumer with liver or kidney disease	ask a doctor

Claritin ® (CLARITIN ®)

Active ingredients (in each tablet)	Purpose
Loratadine 10 mg	Antihistamine

Other Information (Other information)

Safety sealed: do not use if the individual blister unit imprinted with Claritin ^®is open or torn
Store between 20 ^o to 25 ^{o C}(68 ^oto 77 ^oF)
Protect from excessive moisture

Inactive Ingredients (Inactive ingredients)

Corn starch, lactose monohydrate, magnesium stearate

Questions and Comments?

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

Dist. by: Bayer HealthCare LLC

Whippany, NJ 07981

Product of India

Do not use if pouch is torn or broken.

Repackaged and distributed by:

RJ General

2024 Northwest Drive

Cincinnati OH 45231

Principal Display Panel 25 Tablet Pouch Carton (PRINCIPAL DISPLAY PANEL - 25 Tablet Pouch Carton)

Non-Drowsy*

Claritin ^®

loratadine tablets 10 mg/ antihistamine

Indoor & Outdoor Allergies

Relief of:

runny nose
itchy, watery eyes
sneezing
itching of the throat or nose

Advanced Ingredient Data

[{"name": "LACTOSE MONOHYDRATE", "unii": "EWQ57Q8I5X", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "MAGNESIUM STEARATE", "unii": "70097M6I30", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "STARCH, CORN", "unii": "O8232NY3SJ", "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)

{"USE": "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", "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 don not take more than directed. Taking more than directed may cause drowsiness. Stop use and ask doctor if an allergic reaction to this product occurs. Seek medical help right away. If pregnant or breast-feeding, ask 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.", "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 consumer with liver or kidney disease ask a doctor", "CLARITIN ®": "Active ingredients (in each tablet) Purpose Loratadine 10 mg Antihistamine", "Other information": "Safety sealed: do not use if the individual blister unit imprinted with Claritin ® is open or torn Store between 20 o to 25 o C (68 o to 77 o F) Protect from excessive moisture", "Inactive ingredients": "Corn starch, lactose monohydrate, magnesium stearate", "Questions and Comments?": "1-800-CLARITIN(1-800-252-7484) or www.claritin.com Dist. by: Bayer HealthCare LLC Whippany, NJ 07981 Product of India Do not use if pouch is torn or broken. Repackaged and distributed by: RJ General 2024 Northwest Drive Cincinnati OH 45231", "PRINCIPAL DISPLAY PANEL - 25 Tablet Pouch Carton": "Non-Drowsy* Claritin ® loratadine tablets 10 mg/ antihistamine Indoor & Outdoor Allergies Relief of: runny nose itchy, watery eyes sneezing itching of the throat or nose "}

Additional Information

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Source: dailymed · Ingested: 2026-02-15T12:07:14.548458 · Updated: 2026-03-14T23:10:29.645873