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

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

Medication Information

Active Ingredient

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

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

Other Information

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

Inactive Ingredients

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

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

Section 51945-4

Loratadine 10mg Tablet

Do Not Use

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

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)

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

Active Ingredient (Active ingredient (in each tablet))

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

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

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

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

Section 51945-4 (51945-4)

Loratadine 10mg Tablet

Do Not Use (Do not use)

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

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)

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