Loratadine tablets USP, 10mg/antihistamine

Set ID
d778c4d2-184a-4dc8-9351-66d81d0618f2
Manufacturer
Preferred Pharmaceuticals Inc.
Effective date
2025-07-23
Label type
HUMAN OTC DRUG LABEL
Version
2
Source
full-release
Hydrated at
2026-06-01 01:08:29

Key Label Information

Active Ingredients And Purpose

ACTIVE INGREDIENT(S)

Active ingredient (in each tablet) Loratadine USP, 10 mg

PURPOSE

Antihistamine

Uses

USE(S)

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

Warnings

WARNINGS

DO NOT USE

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

ASK A DOCTOR BEFORE USE IF YOU HAVE

liver or kidney disease. Your doctor should determine if you need a different dose.

ASK A DOCTOR OR PHARMACIST BEFORE USE IF

Directions And Dosage

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 Label Information

INACTIVE INGREDIENTS

corn starch, lactose monohydrate, magnesium stearate, pregelatinized starch Repackaged By: Preferred Pharmaceuticals Inc.

QUESTIONS OR COMMENTS?

Call 1-888-588-1418

PRINCIPAL DISPLAY PANEL

Loratadine-tablets-USP-10mg-30's-carton

NDC Codes

Ingredients

NameUNIIKind
STARCH, CORNO8232NY3SJIACT
LACTOSE MONOHYDRATEEWQ57Q8I5XIACT
MAGNESIUM STEARATE70097M6I30IACT
LORATADINE7AJO3BO7QNACTIB

Complete SPL Sections

ACTIVE INGREDIENT(S)

OTC - ACTIVE INGREDIENT SECTION

Active ingredient (in each tablet) Loratadine USP, 10 mg

PURPOSE

OTC - PURPOSE SECTION

Antihistamine

USE(S)

INDICATIONS & USAGE SECTION

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

WARNINGS

WARNINGS SECTION

DO NOT USE

OTC - DO NOT USE SECTION

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

ASK A DOCTOR BEFORE USE IF YOU HAVE

OTC - ASK DOCTOR SECTION

liver or kidney disease. Your doctor should determine if you need a different dose.

ASK A DOCTOR OR PHARMACIST BEFORE USE IF

OTC - ASK DOCTOR/PHARMACIST SECTION

WHEN USING THIS PRODUCT

OTC - WHEN USING SECTION

do not take more than directed. Taking more than directed may cause drowsiness.

STOP USE AND ASK DOCTOR IF

OTC - STOP USE SECTION

an allergic reaction to this product occurs. Seek medical help right away.

PREGNANCY/BREASTFEEDING

OTC - PREGNANCY OR BREAST FEEDING SECTION

ask a health professional before use.

KEEP OUT OF REACH OF CHILDREN

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

In case of overdose, get medical help or contact a Poison Control Center right away.

DIRECTIONS

DOSAGE & ADMINISTRATION SECTION

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

SPL UNCLASSIFIED SECTION

Bottles: • Tamper-evident: do not use if foil seal under cap, printed with "SEALED for YOUR PROTECTION" is missing, open or broken • store between 20° to 25°C (68° to 77°F) Blisters packs: • safety sealed: do not use if the individual blister unit imprinted with loratadine is open or torn • store between 20° to 25°C (68° to 77°F) • protect from excessive moisture

INACTIVE INGREDIENTS

INACTIVE INGREDIENT SECTION

corn starch, lactose monohydrate, magnesium stearate, pregelatinized starch Repackaged By: Preferred Pharmaceuticals Inc.

QUESTIONS OR COMMENTS?

SPL UNCLASSIFIED SECTION

Call 1-888-588-1418

PRINCIPAL DISPLAY PANEL

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Loratadine-tablets-USP-10mg-30's-carton

Source Document

Official SPL XML cached by FDA.report · DailyMed PDF

XML object
dailymed/d778c4d2-184a-4dc8-9351-66d81d0618f2/16bd1183-a291-4f6d-8284-47e1e0ed49a2.xml
XML SHA-256
b17cf227edc49633bc7c79e9e4840284bd0605cd2ae4482290cc66255f59a592
XML bytes
30107

Legacy File Index

FolderFileDate
otc16bd1183-a291-4f6d-8284-47e1e0ed49a2.xml2025-07-25
otcd778c4d2-184a-4dc8-9351-66d81d0618f2.xml2024-03-22
otcloratadine-tablets-10mg-30s-carton.jpg2024-03-22