Drug Facts

Drug Facts

SPL v4

SPL

SPL Set ID 0607e8b0-b231-47bb-8133-10d46e7c0ac7

Route

ORAL

Published

Effective Date 2011-12-30

Document Type 34390-5 HUMAN OTC DRUG LABEL

Composition & Product

Active Ingredients

Loratadine (10 mg)

Inactive Ingredients

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

Identifiers & Packaging

Pill Appearance

Imprint: GG296 Shape: round Color: white Size: 6 mm Score: 1

Marketing Status

ANDA Active Since 2018-12-31

Description

Loratadine, USP 10 mg

Purpose

Antihistamine

How Supplied

NDC: 71335-1461-1: 20 Tablets in a BOTTLE NDC: 71335-1461-2: 30 Tablets in a BOTTLE NDC: 71335-1461-3: 60 Tablets in a BOTTLE NDC: 71335-1461-4: 14 Tablets in a BOTTLE NDC: 71335-1461-5: 10 Tablets in a BOTTLE NDC: 71335-1461-6: 90 Tablets in a BOTTLE NDC: 71335-1461-7: 28 Tablets in a BOTTLE NDC: 71335-1461-8: 15 Tablets in a BOTTLE NDC: 71335-1461-9: 100 Tablets in a BOTTLE

Medication Information

Purpose

Antihistamine

How Supplied

NDC: 71335-1461-1: 20 Tablets in a BOTTLE

NDC: 71335-1461-2: 30 Tablets in a BOTTLE

NDC: 71335-1461-3: 60 Tablets in a BOTTLE

NDC: 71335-1461-4: 14 Tablets in a BOTTLE

NDC: 71335-1461-5: 10 Tablets in a BOTTLE

NDC: 71335-1461-6: 90 Tablets in a BOTTLE

NDC: 71335-1461-7: 28 Tablets in a BOTTLE

NDC: 71335-1461-8: 15 Tablets in a BOTTLE

NDC: 71335-1461-9: 100 Tablets in a BOTTLE

Description

Loratadine, USP 10 mg

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

Section 51945-4

Loratadine 10mg Tablet

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

Do Not Use

if you have ever had an allergic reaction to this product or any of its ingredients.

Other Information

store at 20º-25ºC (68º-77ºF) (see UPS Controlled Room Temperature)

Inactive Ingredients

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

Questions Or Comments?

Call 1-888-588-1418 Monday-Friday 9AM-5PM EST

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.

Keep Out of Reach of Children.

In case of overdose, get medical help or contact a Poison Control Center right away (1-800-222-1222)

Active Ingredient (in Each Tablet)

Loratadine, USP 10 mg

Ask A Doctor Before Use If You Have

liver or kidney disease. Your doctor should determine if you need a different dose.

Structured Label Content

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

Section 51945-4 (51945-4)

Loratadine 10mg Tablet

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

Do Not Use (Do not use)

if you have ever had an allergic reaction to this product or any of its ingredients.

How Supplied (HOW SUPPLIED)

NDC: 71335-1461-1: 20 Tablets in a BOTTLE

NDC: 71335-1461-2: 30 Tablets in a BOTTLE

NDC: 71335-1461-3: 60 Tablets in a BOTTLE

NDC: 71335-1461-4: 14 Tablets in a BOTTLE

NDC: 71335-1461-5: 10 Tablets in a BOTTLE

NDC: 71335-1461-6: 90 Tablets in a BOTTLE

NDC: 71335-1461-7: 28 Tablets in a BOTTLE

NDC: 71335-1461-8: 15 Tablets in a BOTTLE

NDC: 71335-1461-9: 100 Tablets in a BOTTLE

Other Information (Other information)

store at 20º-25ºC (68º-77ºF) (see UPS Controlled Room Temperature)

Inactive Ingredients (Inactive ingredients)

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

Questions Or Comments? (Questions or comments?)

Call 1-888-588-1418 Monday-Friday 9AM-5PM EST

When Using This Product, (When using this product,)

do not take more than directed. Taking more than directed may cause drowsiness.

Stop Use and Ask a Doctor If (Stop use and ask a doctor if)

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

If Pregnant Or Breast Feeding, (If pregnant or breast-feeding,)

ask a health professional before use.

Keep Out of Reach of Children. (Keep out of reach of children.)

In case of overdose, get medical help or contact a Poison Control Center right away (1-800-222-1222)

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

Loratadine, USP 10 mg

Ask A Doctor Before Use If You Have (Ask a doctor before use if you have)

liver or kidney disease. Your doctor should determine if you need a different dose.

Advanced Ingredient Data

[{"name": "LORATADINE", "unii": "7AJO3BO7QN", "classCode": "ACTIB", "strengthNumerator": "10", "strengthDenominator": "1", "strengthNumeratorUnit": "mg", "strengthDenominatorUnit": "1"}, {"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": "SODIUM STARCH GLYCOLATE TYPE A CORN", "unii": "AG9B65PV6B", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}]

Raw Label Data

All Sections (JSON)

{"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", "51945-4": "Loratadine 10mg Tablet", "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", "Do not use": "if you have ever had an allergic reaction to this product or any of its ingredients.", "HOW SUPPLIED": "NDC: 71335-1461-1: 20 Tablets in a BOTTLE NDC: 71335-1461-2: 30 Tablets in a BOTTLE NDC: 71335-1461-3: 60 Tablets in a BOTTLE NDC: 71335-1461-4: 14 Tablets in a BOTTLE NDC: 71335-1461-5: 10 Tablets in a BOTTLE NDC: 71335-1461-6: 90 Tablets in a BOTTLE NDC: 71335-1461-7: 28 Tablets in a BOTTLE NDC: 71335-1461-8: 15 Tablets in a BOTTLE NDC: 71335-1461-9: 100 Tablets in a BOTTLE", "Other information": "store at 20º-25ºC (68º-77ºF) (see UPS Controlled Room Temperature)", "Inactive ingredients": "lactose monohydrate, magnesium stearate, microcrystalline cellulose, sodium starch glycolate", "Questions or comments?": "Call 1-888-588-1418 Monday-Friday 9AM-5PM EST", "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.", "Keep out of reach of children.": "In case of overdose, get medical help or contact a Poison Control Center right away (1-800-222-1222)", "Active ingredient (in each tablet)": "Loratadine, USP 10 mg", "Ask a doctor before use if you have": "liver or kidney disease. Your doctor should determine if you need a different dose."}

Additional Information

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Source: dailymed · Ingested: 2026-02-15T12:00:04.299016 · Updated: 2026-03-14T23:00:23.363901