Drug Facts

Drug Facts

SPL v3

SPL

SPL Set ID eb7196aa-898b-48d3-a6c7-8b52ff740b30

Route

ORAL

Published

Effective Date 2019-04-29

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 Potato

Identifiers & Packaging

Pill Appearance

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

Marketing Status

ANDA Active Since 2016-02-01

Description

Loratadine, USP 10 mg

Purpose

Antihistamine

How Supplied

Product: 50090-3620 NDC: 50090-3620-0 10 TABLET in a BOTTLE NDC: 50090-3620-3 15 TABLET in a BOTTLE, PLASTIC NDC: 50090-3620-4 30 TABLET in a BOTTLE, PLASTIC NDC: 50090-3620-5 90 TABLET in a BOTTLE, PLASTIC NDC: 50090-3620-1 20 TABLET in a BOTTLE, PLASTIC NDC: 50090-3620-6 7 TABLET in a BOTTLE, PLASTIC

Medication Information

Purpose

Antihistamine

How Supplied

Product: 50090-3620

NDC: 50090-3620-0 10 TABLET in a BOTTLE

NDC: 50090-3620-3 15 TABLET in a BOTTLE, PLASTIC

NDC: 50090-3620-4 30 TABLET in a BOTTLE, PLASTIC

NDC: 50090-3620-5 90 TABLET in a BOTTLE, PLASTIC

NDC: 50090-3620-1 20 TABLET in a BOTTLE, PLASTIC

NDC: 50090-3620-6 7 TABLET in a BOTTLE, PLASTIC

Description

Loratadine, USP 10 mg

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

Section 42229-5

Manufactured for: Northstar Rx LLC

Memphis, TN 38141.

Manufactured by: Sandoz Inc.

Princeton, NJ 08540.

Section 44425-7

•
Store at 20° to 25°C (68° to 77°F) (see USP Controlled Room Temperature).

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.

Loratadine

Other Information

•
Safety sealed: do not use if the imprinted bottle seal is open or torn (for bottle only).
•
Safety sealed: do not use if open or torn (for blister package only).

Inactive Ingredients

Lactose monohydrate, magnesium stearate, microcrystalline cellulose and sodium starch glycolate.

Questions Or Comments?

1-800-206-7821

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.

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

Section 42229-5 (42229-5)

Manufactured for: Northstar Rx LLC

Memphis, TN 38141.

Manufactured by: Sandoz Inc.

Princeton, NJ 08540.

Section 44425-7 (44425-7)

•
Store at 20° to 25°C (68° to 77°F) (see USP Controlled Room Temperature).

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.

Loratadine

How Supplied (HOW SUPPLIED)

Product: 50090-3620

NDC: 50090-3620-0 10 TABLET in a BOTTLE

NDC: 50090-3620-3 15 TABLET in a BOTTLE, PLASTIC

NDC: 50090-3620-4 30 TABLET in a BOTTLE, PLASTIC

NDC: 50090-3620-5 90 TABLET in a BOTTLE, PLASTIC

NDC: 50090-3620-1 20 TABLET in a BOTTLE, PLASTIC

NDC: 50090-3620-6 7 TABLET in a BOTTLE, PLASTIC

Other Information

•
Safety sealed: do not use if the imprinted bottle seal is open or torn (for bottle only).
•
Safety sealed: do not use if open or torn (for blister package only).

Inactive Ingredients

Lactose monohydrate, magnesium stearate, microcrystalline cellulose and sodium starch glycolate.

Questions Or Comments? (Questions or comments?)

1-800-206-7821

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 (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.

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 POTATO", "unii": "5856J3G2A2", "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 • itchy, watery eyes • sneezing • itching of the nose or throat", "42229-5": "© 2005 NorthStar Healthcare Holdings I10-2015M Manufactured for: Northstar Rx LLC Memphis, TN 38141. Manufactured by: Sandoz Inc. Princeton, NJ 08540.", "44425-7": "• Store at 20° to 25°C (68° to 77°F) (see USP Controlled Room Temperature).", "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": "Product: 50090-3620 NDC: 50090-3620-0 10 TABLET in a BOTTLE NDC: 50090-3620-3 15 TABLET in a BOTTLE, PLASTIC NDC: 50090-3620-4 30 TABLET in a BOTTLE, PLASTIC NDC: 50090-3620-5 90 TABLET in a BOTTLE, PLASTIC NDC: 50090-3620-1 20 TABLET in a BOTTLE, PLASTIC NDC: 50090-3620-6 7 TABLET in a BOTTLE, PLASTIC", "Other Information": "• Safety sealed: do not use if the imprinted bottle seal is open or torn (for bottle only). • Safety sealed: do not use if open or torn (for blister package only).", "Inactive Ingredients": "Lactose monohydrate, magnesium stearate, microcrystalline cellulose and sodium starch glycolate.", "Questions or comments?": "1-800-206-7821", "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.", "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

Back to search View SPL set listing Open on DailyMed ↗

Source: dailymed · Ingested: 2026-02-15T11:56:48.602533 · Updated: 2026-03-14T22:55:31.631898