Drug Facts

Composition & Product

Active Ingredients

Loratadine (10 mg)

Inactive Ingredients

Magnesium Stearate Lactose Starch, Corn

Identifiers & Packaging

Pill Appearance

Imprint: RX526 Shape: round Color: white Size: 6 mm Score: 1

Marketing Status

ANDA Active Since 2012-10-15

Medication Information

Warnings and Precautions

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.

Indications and Usage

Uses: • temporarily relieves these symptoms due to hay fever

or other upper respiratory allergies: • runny nose • sneezing

• itchy, watery eyes • itching of the nose or throat

Dosage and Administration

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

Description

Active Ingredients Loratadine USP 10 mg

Section 50565-1

KEEP OUT OF REACH OF CHILDREN.

Section 51727-6

Inactive

ingredients: corn starch, lactose monohydrate,

magnesium stearate, pregelatinized starch

Section 51945-4

MM1

Section 53414-9

If pregnant or

breast-feeding, ask a health professional before use.

Section 55105-1

Antihistamine

Section 55106-9

Active Ingredients

Loratadine USP 10 mg

Structured Label Content

Indications and Usage (34067-9)

Uses: • temporarily relieves these symptoms due to hay fever

or other upper respiratory allergies: • runny nose • sneezing

• itchy, watery eyes • itching of the nose or throat

Dosage and Administration (34068-7)

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

Warnings and Precautions (34071-1)

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.

Section 50565-1 (50565-1)

KEEP OUT OF REACH OF CHILDREN.

Section 51727-6 (51727-6)

Inactive

ingredients: corn starch, lactose monohydrate,

magnesium stearate, pregelatinized starch

Section 51945-4 (51945-4)

MM1

Section 53414-9 (53414-9)

If pregnant or

breast-feeding, ask a health professional before use.

Section 55105-1 (55105-1)

Antihistamine

Section 55106-9 (55106-9)

Active Ingredients

Loratadine USP 10 mg

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": "LACTOSE", "unii": "J2B2A4N98G", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "STARCH, CORN", "unii": "O8232NY3SJ", "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 • sneezing • itchy, watery eyes • itching of the nose or throat", "34068-7": "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", "34071-1": "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.", "50565-1": "KEEP OUT OF REACH OF CHILDREN.", "51727-6": "Inactive ingredients: corn starch, lactose monohydrate, magnesium stearate, pregelatinized starch", "51945-4": "MM1", "53414-9": "If pregnant or breast-feeding, ask a health professional before use.", "55105-1": "Antihistamine", "55106-9": "Active Ingredients Loratadine USP 10 mg"}

Drug Facts

Drug Facts

Composition & Product

Identifiers & Packaging

Medication Information

Structured Label Content

Advanced Ingredient Data

Raw Label Data

Additional Information