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

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

Medication Information

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.

Active Ingredient

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

Purpose

Antihistamine

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

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

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

Questions?

call 1-800-540-3765

Section 50565-1

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

Loratadine

Structured Label Content

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.

Active Ingredient (Active ingredient (in each tablet))

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

Purpose

Antihistamine

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

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

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

Questions?

call 1-800-540-3765

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.

Loratadine (loratadine)

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