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

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

Medication Information

Active Ingredient

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

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

•
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.

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

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).

Do Not Use

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

Loratadine

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.

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
•
itchy, watery eyes
•
sneezing
•
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

•
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.

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

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).

Do Not Use (Do not use)

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

Loratadine

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.

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

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