Mckesson Loratadine 10 Mg

SPL v5

SPL

SPL Set ID c6a3056e-792e-52a4-e053-2a95a90a8361

Route

ORAL

Published

Effective Date 2025-07-01

Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients

Loratadine (10 mg)

Inactive Ingredients

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

Identifiers & Packaging

Pill Appearance

Imprint: RX;526 Shape: round Color: white Size: 6 mm Score: 1

Marketing Status

ANDA Active Since 2021-08-02 Until 2026-09-30

Description

Drug Facts

Medication Information

Warnings and Precautions

Warnings

Indications and Usage

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

Dosage and Administration

Directions

Adults and children (6 years and older): 1 tablet daily; not more than 1 tablet in 24 hours.

Children under 6 years: Ask a doctor

Consumers with liver or kidney disease: Ask a doctor

Description

Drug Facts

Section 42229-5

Drug Facts

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 a doctor if

an allergic reaction to this product occurs. Seek medical help right away.

Section 50567-7

When using this product do not take more than directed.

Taking more than directed may cause drowsiness.

Section 50569-3

Ask a doctor before use if you have liver or kidney disease.

Your doctor should determine if you need a different dose.

Section 50570-1

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

Section 51727-6

Inactive ingredients

lactose monohydrate, magnesium stearate, sodium starch glycolate, pregelatinized starch.

Section 51945-4

NDC 68599-4784-6

McKesson

Loratadine 10 mg

Relieves sneezing, runny nose, itching and watering of the eyes due to upper respiratory allergies.

1 per Pack

50 Packs Per Box

MFR # 82478

Section 53413-1

Questions or comments?

Call 1-800-777-4908

Section 53414-9

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

Section 55105-1

Purpose

Antihistamine

Section 55106-9

Active ingredient (in each tablet)

Loratadine 10 mg

Section 60561-8

Other information

store between 68º and 77ºF (20º and 25ºC )
protect from excessive moisture
tamper evident sealed packets
do not use any opened or torn packets

Structured Label Content

Indications and Usage (34067-9)

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

Dosage and Administration (34068-7)

Directions

Adults and children (6 years and older): 1 tablet daily; not more than 1 tablet in 24 hours.

Children under 6 years: Ask a doctor

Consumers with liver or kidney disease: Ask a doctor

Warnings and Precautions (34071-1)

Warnings

Section 42229-5 (42229-5)

Drug Facts

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 a doctor if

an allergic reaction to this product occurs. Seek medical help right away.

Section 50567-7 (50567-7)

When using this product do not take more than directed.

Taking more than directed may cause drowsiness.

Section 50569-3 (50569-3)

Ask a doctor before use if you have liver or kidney disease.

Your doctor should determine if you need a different dose.

Section 50570-1 (50570-1)

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

Section 51727-6 (51727-6)

Inactive ingredients

lactose monohydrate, magnesium stearate, sodium starch glycolate, pregelatinized starch.

Section 51945-4 (51945-4)

NDC 68599-4784-6

McKesson

Loratadine 10 mg

Relieves sneezing, runny nose, itching and watering of the eyes due to upper respiratory allergies.

1 per Pack

50 Packs Per Box

MFR # 82478

Section 53413-1 (53413-1)

Questions or comments?

Call 1-800-777-4908

Section 53414-9 (53414-9)

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

Section 55105-1 (55105-1)

Purpose

Antihistamine

Section 55106-9 (55106-9)

Active ingredient (in each tablet)

Loratadine 10 mg

Section 60561-8 (60561-8)

Other information

store between 68º and 77ºF (20º and 25ºC )
protect from excessive moisture
tamper evident sealed packets
do not use any opened or torn packets

Advanced Ingredient Data

[{"name": "LORATADINE", "unii": "7AJO3BO7QN", "classCode": "ACTIB", "strengthNumerator": "10", "strengthDenominator": "1", "strengthNumeratorUnit": "mg", "strengthDenominatorUnit": "1"}, {"name": "MAGNESIUM STEARATE", "unii": "70097M6I30", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "WATER", "unii": "059QF0KO0R", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "LACTOSE MONOHYDRATE", "unii": "EWQ57Q8I5X", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "STARCH, CORN", "unii": "O8232NY3SJ", "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"}, {"name": "STARCH, CORN", "unii": "O8232NY3SJ", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "MAGNESIUM STEARATE", "unii": "70097M6I30", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "LACTOSE MONOHYDRATE", "unii": "EWQ57Q8I5X", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}]

Raw Label Data

All Sections (JSON)

{"34067-9": "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", "34068-7": "Directions Adults and children (6 years and older): 1 tablet daily; not more than 1 tablet in 24 hours. Children under 6 years: Ask a doctor Consumers with liver or kidney disease: Ask a doctor", "34071-1": "Warnings", "42229-5": "Drug Facts", "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 a 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.", "51727-6": "Inactive ingredients lactose monohydrate, magnesium stearate, sodium starch glycolate, pregelatinized starch.", "51945-4": "NDC 68599-4784-6 McKesson Loratadine 10 mg Relieves sneezing, runny nose, itching and watering of the eyes due to upper respiratory allergies. 1 per Pack 50 Packs Per Box MFR # 82478", "53413-1": "Questions or comments? Call 1-800-777-4908", "53414-9": "If pregnant or breast-feeding, ask a health professional before use.", "55105-1": "Purpose Antihistamine", "55106-9": "Active ingredient (in each tablet) Loratadine 10 mg", "60561-8": "Other information store between 68º and 77ºF (20º and 25ºC ) protect from excessive moisture tamper evident sealed packets do not use any opened or torn packets"}

Additional Information

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Source: dailymed · Ingested: 2026-02-15T12:05:10.267644 · Updated: 2026-03-14T23:13:11.905913