NON-DROWSY 24 HOUR Allergy Relief Loratadine Antihistamine

Set ID
1d182bd6-ad72-4352-b983-407a48c317f0
Manufacturer
Gobrands, Inc
Effective date
2025-01-25
Label type
HUMAN OTC DRUG LABEL
Version
5
Source
full-release
Hydrated at
2026-06-01 00:53:39

Key Label Information

Active Ingredients And Purpose

Active Ingredient (in each tablet)

Loratadine,10 mg

Purpose

Antihistamine

Uses

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

Warnings

Warnings

Directions And Dosage

Directions

adults & children 6 years & 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

Other information

● store between 20° to 25°C (68° to 77°F)

Inactive ingredients

corn starch, lactose monohydrate, magnesium stearate, povidone

Questions or comments?

1-888-333-9792

PRINCIPAL DISPLAY PANEL

NDC Codes

Ingredients

NameUNIIKind
STARCH, CORNO8232NY3SJIACT
LACTOSE MONOHYDRATEEWQ57Q8I5XIACT
MAGNESIUM STEARATE70097M6I30IACT
POVIDONEFZ989GH94EIACT
LORATADINE7AJO3BO7QNACTIB

Complete SPL Sections

Active Ingredient (in each tablet)

OTC - ACTIVE INGREDIENT SECTION

Loratadine,10 mg

Purpose

OTC - PURPOSE SECTION

Antihistamine

Uses

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

Directions

DOSAGE & ADMINISTRATION SECTION

adults & children 6 years & 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

STORAGE AND HANDLING SECTION

● store between 20° to 25°C (68° to 77°F)

Inactive ingredients

INACTIVE INGREDIENT SECTION

corn starch, lactose monohydrate, magnesium stearate, povidone

Questions or comments?

OTC - QUESTIONS SECTION

1-888-333-9792

PRINCIPAL DISPLAY PANEL

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Source Document

Official SPL XML cached by FDA.report · DailyMed PDF

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XML SHA-256
e6053ff279fa669d0e29347d512ae57eb676d9b61fb75154ae934b484851b808
XML bytes
21038

Legacy File Index

FolderFileDate
otc2c81c9aa-35e4-6008-e063-6294a90a9bc9.xml2025-01-26
otc29ba15a4-8de9-e97f-e063-6394a90a6c9a.xml2024-12-22
otc0c05574c-f99c-5d92-e063-6394a90a9d00.xml2023-12-09
otcdf24ad04-af7d-5bc3-e053-2995a90a553b.xml2022-05-17
otcLoratadine carton.jpg2022-05-17
otcLoratadine label.jpg2022-05-17