Drug Facts 453

SPL v1

SPL

SPL Set ID 59905847-f1a5-0dee-e053-2a91aa0aafed

Route

ORAL

Published

Effective Date 2015-11-04

Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients

Loratadine (10 mg)

Inactive Ingredients

Lactose Monohydrate Magnesium Stearate Cellulose, Microcrystalline 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 2017-09-19

Description

Loratadine, USP 10 mg

Purpose

Antihistamine

Medication Information

Purpose

Antihistamine

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

10-2015M

Sandoz Inc.

Princeton, NJ 08540

Section 44425-7

Store at 20°-25°C (68°-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.

10 Mg Label

NDC 67046-453-30 Non-Drowsy*

Loratadine

Tablets, USP

10 mg

Antihistamine

Indoor & Outdoor Allergies

30 Tablets

SANDOZ

24 Hour

Relief of:

Sneezing

Runny Nose

Itchy, Watery

Eyes

Itchy Throat

or Nose

* When taken as directed.

See Drug Facts Panel.

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?

1-800-525-8747

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)

10-2015M

Sandoz Inc.

Princeton, NJ 08540

Section 44425-7 (44425-7)

Store at 20°-25°C (68°-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.

10 Mg Label (10 mg Label)

NDC 67046-453-30 Non-Drowsy*

Loratadine

Tablets, USP

10 mg

Antihistamine

Indoor & Outdoor Allergies

30 Tablets

SANDOZ

24 Hour

Relief of:

Sneezing

Runny Nose

Itchy, Watery

Eyes

Itchy Throat

or Nose

* When taken as directed.

See Drug Facts Panel.

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?)

1-800-525-8747

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": "LACTOSE MONOHYDRATE", "unii": "EWQ57Q8I5X", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "MAGNESIUM STEARATE", "unii": "70097M6I30", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "CELLULOSE, MICROCRYSTALLINE", "unii": "OP1R32D61U", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "SODIUM STARCH GLYCOLATE TYPE A POTATO", "unii": "5856J3G2A2", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "LORATADINE", "unii": "7AJO3BO7QN", "classCode": "ACTIB", "strengthNumerator": "10", "strengthDenominator": "1", "strengthNumeratorUnit": "mg", "strengthDenominatorUnit": "1"}]

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": "10-2015M Sandoz Inc. Princeton, NJ 08540", "44425-7": "Store at 20°-25°C (68°-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.", "10 mg Label": "NDC 67046-453-30 Non-Drowsy* Loratadine Tablets, USP 10 mg Antihistamine Indoor & Outdoor Allergies 30 Tablets SANDOZ 24 Hour Relief of: Sneezing Runny Nose Itchy, Watery Eyes Itchy Throat or Nose * When taken as directed. See Drug Facts Panel.", "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?": "1-800-525-8747", "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: 2026-02-15T11:56:24.897019 · Updated: 2026-03-14T22:54:51.534540