Loratadine Tablets, 10 Mg

SPL v3

SPL

SPL Set ID e96b4671-82dc-4cc6-a8bf-ef6f1efd8a7d

Route

ORAL

Published

Effective Date 2024-08-07

Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients

Loratadine (10 mg)

Inactive Ingredients

Lactose Monohydrate Starch, Corn Magnesium Stearate Sodium Starch Glycolate Type A Potato

Identifiers & Packaging

Pill Appearance

Imprint: G;10 Shape: round Color: white Size: 7 mm Score: 1

Marketing Status

ANDA Active Since 2020-01-01

Description

Loratadine 10 mg

Purpose

Antihistamine

Medication Information

Purpose

Antihistamine

Description

Loratadine 10 mg

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

Section 50565-1

Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center (1-800-222-1222) right away.

Section 50566-9

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

Section 50567-7

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

Section 50569-3

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

Section 50570-1

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

Section 53414-9

If pregnant or breast-feeding,ask a health professional before use.

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

Questions?

call 1-800-630-8895

Active Ingredient

Loratadine 10 mg

Other Information

store between 20° and 25°C (68° and 77°F)
protect from excessive moisture

Inactive Ingredients

lactose monohydrate, magnesium stearate, pregelatinized starch (maize), sodium starch glycolate

Principal Display Panel

NDC 80513-711-03

Compare to the Active Ingredient in Claritin ^®*

Loratadine 10 mg

Allergy Relief

Non-Drowsy**

Antihistamine

24 Hour Relief of:

Sneezing, runny nose
Itchy, watery eyes
Itchy throat or nose

Original Prescription Strength

**When Taken as Directed. See Drug Facts Panel.

300 Tablets

DO NOT USE IF PRINTED SEAL UNDER CAP IS MISSING OR DAMAGED

*This product is not manufactured or distributed by the owner of the registered trademark Claritin ^®

Distributed by:

ADVANCED RX LLC,

1942 NE 163rd St

North Miami Beach,

FL 33162 U.S.A.

Structured Label Content

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

Section 50565-1 (50565-1)

Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center (1-800-222-1222) right away.

Section 50566-9 (50566-9)

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

Section 50567-7 (50567-7)

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

Section 50569-3 (50569-3)

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

Section 50570-1 (50570-1)

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

Section 53414-9 (53414-9)

If pregnant or breast-feeding,ask a health professional before use.

Purpose

Antihistamine

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

Questions?

call 1-800-630-8895

Active Ingredient (Active ingredient)

Loratadine 10 mg

Other Information (Other information)

store between 20° and 25°C (68° and 77°F)
protect from excessive moisture

Inactive Ingredients (Inactive ingredients)

lactose monohydrate, magnesium stearate, pregelatinized starch (maize), sodium starch glycolate

Principal Display Panel (PRINCIPAL DISPLAY PANEL)

NDC 80513-711-03

Compare to the Active Ingredient in Claritin ^®*

Loratadine 10 mg

Allergy Relief

Non-Drowsy**

Antihistamine

24 Hour Relief of:

Sneezing, runny nose
Itchy, watery eyes
Itchy throat or nose

Original Prescription Strength

**When Taken as Directed. See Drug Facts Panel.

300 Tablets

DO NOT USE IF PRINTED SEAL UNDER CAP IS MISSING OR DAMAGED

*This product is not manufactured or distributed by the owner of the registered trademark Claritin ^®

Distributed by:

ADVANCED RX LLC,

1942 NE 163rd St

North Miami Beach,

FL 33162 U.S.A.

Advanced Ingredient Data

[{"name": "LACTOSE MONOHYDRATE", "unii": "EWQ57Q8I5X", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "STARCH, CORN", "unii": "O8232NY3SJ", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "MAGNESIUM STEARATE", "unii": "70097M6I30", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "SODIUM STARCH GLYCOLATE TYPE A POTATO", "unii": "5856J3G2A2", "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 itchy, watery eyes sneezing itching of the nose or throat", "50565-1": "Keep out of reach of children . In case of overdose, get medical help or contact a Poison Control Center (1-800-222-1222) right away.", "50566-9": "Stop use and ask doctor if an allergic reaction to this product occurs. Seek medical help right away.", "50567-7": "When using this product do not take more than directed. Taking more than directed may cause drowsiness.", "50569-3": " Ask a doctor before use if you have liver or kidney disease. Your doctor should determine if you need a different dose.", "50570-1": "Do not use if you have ever had an allergic reaction to this product or any of its ingredients.", "53414-9": "If pregnant or breast-feeding, ask a health professional before use.", "Purpose": "Antihistamine", "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", "Questions?": "call 1-800-630-8895", "Active ingredient": "Loratadine 10 mg", "Other information": "store between 20° and 25°C (68° and 77°F) protect from excessive moisture", "Inactive ingredients": "lactose monohydrate, magnesium stearate, pregelatinized starch (maize), sodium starch glycolate", "PRINCIPAL DISPLAY PANEL": "NDC 80513-711-03 Compare to the Active Ingredient in Claritin ® * Loratadine 10 mg Allergy Relief Non-Drowsy** Antihistamine 24 Hour Relief of: Sneezing, runny nose Itchy, watery eyes Itchy throat or nose Original Prescription Strength **When Taken as Directed. See Drug Facts Panel. 300 Tablets DO NOT USE IF PRINTED SEAL UNDER CAP IS MISSING OR DAMAGED *This product is not manufactured or distributed by the owner of the registered trademark Claritin ® Distributed by: ADVANCED RX LLC, 1942 NE 163rd St North Miami Beach, FL 33162 U.S.A."}

Additional Information

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Source: dailymed · Ingested: 2026-02-15T12:05:37.364456 · Updated: 2026-03-14T23:07:45.169331