Loratadine Tablets, Usp Antihistamine

SPL v12

SPL

SPL Set ID 64489b01-a4a7-4c6d-ac84-1dfbd1388d84

Route

ORAL

Published

Effective Date 2025-10-20

Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients

Loratadine (10 mg)

Inactive Ingredients

Starch, Corn Lactose Monohydrate Magnesium Stearate

Identifiers & Packaging

Pill Appearance

Imprint: RX526 Shape: round Color: white Size: 6 mm Score: 1

Marketing Status

ANDA Active Since 2013-06-14

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:

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

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.

Questions?

for Ohm Laboratories call 1-800-406-7984

The drug product contained in this package is from Ohm Laboratories Inc.

Packaged and Distributed by:

American Health Packaging, Columbus, Ohio 43217

Distributed By:

Cardinal Health

Dublin, OH 43017

L4955647-10924 / L4955647-20924

801697

0224801/0119

Other Information

•
store between 20° to 25°C (68° to 77°F)
•
protect from excessive moisture
•
FOR YOUR PROTECTION: Do not use if blister is torn or broken.

Overbagged with 10 tablets per bag, NDC 55154-4976-0

WARNING: This Unit Dose package is not child resistant and is Intended for Institutional Use Only. Keep this and all drugs out of the reach of children.

Inactive Ingredients

Corn starch, lactose monohydrate, magnesium stearate, pregelatinized starch

Principal Display Panel

NDC 55154-4976-0

NON-DROWSY* 24 Hour Allergy Relief

LORATADINE TABLETS, USP 10 mg

Antihistamine

10 TABLETS

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:

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

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.

Questions?

for Ohm Laboratories call 1-800-406-7984

The drug product contained in this package is from Ohm Laboratories Inc.

Packaged and Distributed by:

American Health Packaging, Columbus, Ohio 43217

Distributed By:

Cardinal Health

Dublin, OH 43017

L4955647-10924 / L4955647-20924

801697

0224801/0119

Other Information

•
store between 20° to 25°C (68° to 77°F)
•
protect from excessive moisture
•
FOR YOUR PROTECTION: Do not use if blister is torn or broken.

Overbagged with 10 tablets per bag, NDC 55154-4976-0

WARNING: This Unit Dose package is not child resistant and is Intended for Institutional Use Only. Keep this and all drugs out of the reach of children.

Inactive Ingredients

Corn starch, lactose monohydrate, magnesium stearate, pregelatinized starch

Principal Display Panel

NDC 55154-4976-0

NON-DROWSY* 24 Hour Allergy Relief

LORATADINE TABLETS, USP 10 mg

Antihistamine

10 TABLETS

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": "STARCH, CORN", "unii": "O8232NY3SJ", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "LACTOSE MONOHYDRATE", "unii": "EWQ57Q8I5X", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "MAGNESIUM STEARATE", "unii": "70097M6I30", "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: • itching of the nose or throat • runny nose • itchy, watery eyes • sneezing", "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.", "Questions?": "for Ohm Laboratories call 1-800-406-7984 The drug product contained in this package is from Ohm Laboratories Inc. Packaged and Distributed by: American Health Packaging, Columbus, Ohio 43217 Distributed By: Cardinal Health Dublin, OH 43017 L4955647-10924 / L4955647-20924 801697 0224801/0119", "Other Information": "• store between 20° to 25°C (68° to 77°F) • protect from excessive moisture • FOR YOUR PROTECTION: Do not use if blister is torn or broken. Overbagged with 10 tablets per bag, NDC 55154-4976-0 WARNING: This Unit Dose package is not child resistant and is Intended for Institutional Use Only. Keep this and all drugs out of the reach of children.", "Inactive Ingredients": "Corn starch, lactose monohydrate, magnesium stearate, pregelatinized starch", "Principal Display Panel": "NDC 55154-4976-0 NON-DROWSY* 24 Hour Allergy Relief LORATADINE TABLETS, USP 10 mg Antihistamine 10 TABLETS", "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: 2026-02-15T12:03:34.618229 · Updated: 2026-03-14T23:13:18.140905