788s (658) - DailyMed Details

788s (658)

SPL v8

SPL

SPL Set ID 210fa77a-e33e-48c4-8228-b1cf3ccb7fa4

Route

ORAL

Published

Effective Date 2025-01-30

Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients

Loratadine (10 mg)

Inactive Ingredients

Sodium Starch Glycolate Type A Corn Lactose Monohydrate Magnesium Stearate Microcrystalline Cellulose

Identifiers & Packaging

Pill Appearance

Imprint: 439 Shape: round Color: white Size: 6 mm Score: 1

Marketing Status

ANDA Active Since 2020-02-01

Description

Loratadine, USP 10 mg

Purpose

Antihistamine

How Supplied

Product: 50090-6164 NDC: 50090-6164-4 30 TABLET in a BOTTLE NDC: 50090-6164-5 90 TABLET in a BOTTLE NDC: 50090-6164-0 10 TABLET in a BOTTLE

Medication Information

Purpose

Antihistamine

How Supplied

Product: 50090-6164

NDC: 50090-6164-4 30 TABLET in a BOTTLE

NDC: 50090-6164-5 90 TABLET in a BOTTLE

NDC: 50090-6164-0 10 TABLET in a BOTTLE

Description

Loratadine, USP 10 mg

Uses

temporarily relieves these symptoms due to hay fever and other upper respiratory allergies:

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

Section 50565-1

Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center right away.

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.

Directions

adults and children 12 years and over	1 tablet daily; not more than 1 tablet in 24 hours
children under 12 years of age	ask a doctor
consumers with liver or kidney disease	ask a doctor

Questions?

call 1-800-540-3765

Loratadine

Other Information

TAMPER EVIDENT: Do not use if imprinted seal under cap is missing or broken.
store between 20° to 25°C (68° to 77°F)
protect from light

Inactive Ingredients

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

Active Ingredient (in Each Tablet)

Loratadine, USP 10 mg

Structured Label Content

Uses

temporarily relieves these symptoms due to hay fever and other upper respiratory allergies:

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

Section 50565-1 (50565-1)

Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center right away.

Purpose

Antihistamine

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.

Directions

adults and children 12 years and over	1 tablet daily; not more than 1 tablet in 24 hours
children under 12 years of age	ask a doctor
consumers with liver or kidney disease	ask a doctor

Questions?

call 1-800-540-3765

Loratadine (loratadine)

How Supplied (HOW SUPPLIED)

Product: 50090-6164

NDC: 50090-6164-4 30 TABLET in a BOTTLE

NDC: 50090-6164-5 90 TABLET in a BOTTLE

NDC: 50090-6164-0 10 TABLET in a BOTTLE

Other Information (Other information)

TAMPER EVIDENT: Do not use if imprinted seal under cap is missing or broken.
store between 20° to 25°C (68° to 77°F)
protect from light

Inactive Ingredients (Inactive ingredients)

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

Active Ingredient (in Each Tablet) (Active ingredient (in each tablet))

Loratadine, USP 10 mg

Advanced Ingredient Data

[{"name": "SODIUM STARCH GLYCOLATE TYPE A CORN", "unii": "AG9B65PV6B", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "LACTOSE MONOHYDRATE", "unii": "EWQ57Q8I5X", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "MAGNESIUM STEARATE", "unii": "70097M6I30", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "MICROCRYSTALLINE CELLULOSE", "unii": "OP1R32D61U", "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 and other upper respiratory allergies: runny nose sneezing itching of the nose and throat itchy, watery eyes", "50565-1": "Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center right away.", "Purpose": "Antihistamine", "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.", "Directions": "adults and children 12 years and over 1 tablet daily; not more than 1 tablet in 24 hours children under 12 years of age ask a doctor consumers with liver or kidney disease ask a doctor", "Questions?": "call 1-800-540-3765", "HOW SUPPLIED": "Product: 50090-6164 NDC: 50090-6164-4 30 TABLET in a BOTTLE NDC: 50090-6164-5 90 TABLET in a BOTTLE NDC: 50090-6164-0 10 TABLET in a BOTTLE", "Other information": "TAMPER EVIDENT: Do not use if imprinted seal under cap is missing or broken. store between 20° to 25°C (68° to 77°F) protect from light", "Inactive ingredients": "lactose monohydrate, magnesium stearate, microcrystalline cellulose, sodium starch glycolate", "Active ingredient (in each tablet)": "Loratadine, USP 10 mg"}

Additional Information

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Source: dailymed · Ingested: 2026-02-15T12:05:27.548472 · Updated: 2026-03-14T23:07:17.257844