Loratadine Tablets, 10 Mg

SPL v1

SPL

SPL Set ID 1dd299e7-dfdd-459b-bb2b-83e37dd2e63d

Route

ORAL

Published

Effective Date 2025-04-11

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: 6 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 42229-5

Distributed by:

BI-MART

Eugene, OR 97402

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 toll free 1-844-912-4012

Active Ingredient

Loratadine 10 mg

Other Information

store between 20° and 25°C (68° and 77°F)
protect from excessive moisture
DO NOT USE IF PRINTED SEAL UNDER CAP IS MISSING OR DAMAGED.

Inactive Ingredients

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

Principal Display Panel 10 Tablets

NDC 37835-621-10

Compare to the Active Ingredient in Claritin ^®*

Non-Drowsy**

Allergy Relief

Loratadine 10 mg/Antihistamine

24 Hour Allergy

Relief of:

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

Original Prescription Strength

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

10 Tablets

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

Principal Display Panel 30 Tablets

NDC 37835-621-30

Compare to the Active Ingredient in Claritin ^®*

Non-Drowsy**

Allergy Relief

Loratadine 10 mg/Antihistamine

24 Hour Allergy

Relief of:

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

Original Prescription Strength

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

30 Tablets

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

Principal Display Panel 100 Tablets

NDC 37835-621-01

Compare to the Active Ingredient in Claritin ^®*

Non-Drowsy**

Allergy Relief

Loratadine 10 mg/Antihistamine

24 Hour Allergy

Relief of:

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

Original Prescription Strength

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

100 Tablets

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

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 42229-5 (42229-5)

Distributed by:

BI-MART

Eugene, OR 97402

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 toll free 1-844-912-4012

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

Inactive Ingredients (Inactive ingredients)

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

Principal Display Panel 10 Tablets (PRINCIPAL DISPLAY PANEL-10 Tablets)

NDC 37835-621-10

Compare to the Active Ingredient in Claritin ^®*

Non-Drowsy**

Allergy Relief

Loratadine 10 mg/Antihistamine

24 Hour Allergy

Relief of:

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

Original Prescription Strength

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

10 Tablets

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

Principal Display Panel 30 Tablets (PRINCIPAL DISPLAY PANEL-30 Tablets)

NDC 37835-621-30

Compare to the Active Ingredient in Claritin ^®*

Non-Drowsy**

Allergy Relief

Loratadine 10 mg/Antihistamine

24 Hour Allergy

Relief of:

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

Original Prescription Strength

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

30 Tablets

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

Principal Display Panel 100 Tablets (PRINCIPAL DISPLAY PANEL-100 Tablets)

NDC 37835-621-01

Compare to the Active Ingredient in Claritin ^®*

Non-Drowsy**

Allergy Relief

Loratadine 10 mg/Antihistamine

24 Hour Allergy

Relief of:

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

Original Prescription Strength

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

100 Tablets

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

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", "42229-5": "Distributed by: BI-MART Eugene, OR 97402", "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 toll free 1-844-912-4012", "Active ingredient": "Loratadine 10 mg", "Other information": "store between 20° and 25°C (68° and 77°F) protect from excessive moisture DO NOT USE IF PRINTED SEAL UNDER CAP IS MISSING OR DAMAGED.", "Inactive ingredients": "lactose monohydrate, magnesium stearate, pregelatinized starch (maize), sodium starch glycolate", "PRINCIPAL DISPLAY PANEL-10 Tablets": "NDC 37835-621-10 Compare to the Active Ingredient in Claritin ® * Non-Drowsy** Allergy Relief Loratadine 10 mg/Antihistamine 24 Hour Allergy Relief of: Sneezing, runny nose Itchy, watery eyes Itchy throat or nose Original Prescription Strength **When Taken as Directed. See Drug Facts Panel. 10 Tablets *This product is not manufactured or distributed by the owner of the registered trademark Claritin ®", "PRINCIPAL DISPLAY PANEL-30 Tablets": "NDC 37835-621-30 Compare to the Active Ingredient in Claritin ® * Non-Drowsy** Allergy Relief Loratadine 10 mg/Antihistamine 24 Hour Allergy Relief of: Sneezing, runny nose Itchy, watery eyes Itchy throat or nose Original Prescription Strength **When Taken as Directed. See Drug Facts Panel. 30 Tablets *This product is not manufactured or distributed by the owner of the registered trademark Claritin ®", "PRINCIPAL DISPLAY PANEL-100 Tablets": "NDC 37835-621-01 Compare to the Active Ingredient in Claritin ® * Non-Drowsy** Allergy Relief Loratadine 10 mg/Antihistamine 24 Hour Allergy Relief of: Sneezing, runny nose Itchy, watery eyes Itchy throat or nose Original Prescription Strength **When Taken as Directed. See Drug Facts Panel. 100 Tablets *This product is not manufactured or distributed by the owner of the registered trademark Claritin ®"}

Additional Information

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Source: dailymed · Ingested: 2026-02-15T12:05:53.828228 · Updated: 2026-03-14T23:08:19.346855