Drug Facts

Set ID
abeae0a6-7f41-45e3-b2ae-145a2e633bc7
Manufacturer
Select Brand | Ranbaxy Pharmaceuticals Inc. | Ohm Laboratories Inc.
Effective date
2012-10-02
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-05-31 22:33:17

Key Label Information

Active Ingredients And Purpose

ACTIVE INGREDIENT (IN EACH TABLET)

Loratadine, USP 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

place 1 tablet on tongue; tablet disintegrates, with or without water 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

Aspartame, croscarmellose sodium, fruit flavors, magnesium stearate, mannitol, sodium stearyl fumarate

QUESTIONS?

Call 1-800-406-7984

PRINCIPAL DISPLAY PANEL

select brand ® NDC 15127-979-10 NON-DROWSY * Original Prescription Strength Allergy Relief Tablets Loratadine Orally Disintegrating Tablets, 10 mg Antihistamine 24 Hour Allergy Relief Indoor & Outdoor Allergies No Water Needed Melts in Your Mouth Relief of: Sneezing; Runny Nose; Itchy, Watery Eyes; Itchy Throat or Nose For Adults & Children six years & older! 10 Orally Disintegrating Tablets ٭ Compare to the active ingredient of Claritin ® RediTabs ® * When taken as directed. See Drug Facts Panel. Distributed by: SELECT BRAND ® DISTRIBUTORS 5079375/R0610

NDC Codes

Ingredients

NameUNIIKind
LORATADINE7AJO3BO7QNACTIB
ASPARTAMEZ0H242BBR1IACT
CROSCARMELLOSE SODIUMM28OL1HH48IACT
MAGNESIUM STEARATE70097M6I30IACT
MANNITOL3OWL53L36AIACT
SODIUM STEARYL FUMARATE7CV7WJK4UIIACT

Complete SPL Sections

ACTIVE INGREDIENT (IN EACH TABLET)

OTC - ACTIVE INGREDIENT SECTION

Loratadine, USP 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

place 1 tablet on tongue; tablet disintegrates, with or without water 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

Phenylketonurics: Contains Phenylalanine 0.6 mg Per Tablet. TAMPER EVIDENT: DO NOT USE IF BLISTER UNITS ARE TORN, BROKEN OR SHOW ANY SIGNS OF TAMPERING. store between 20° to 25° C (68° to 77° F). Protect from excessive moisture. keep in a dry place. use tablet immediately after opening individual blister.

INACTIVE INGREDIENTS

INACTIVE INGREDIENT SECTION

Aspartame, croscarmellose sodium, fruit flavors, magnesium stearate, mannitol, sodium stearyl fumarate

QUESTIONS?

OTC - QUESTIONS SECTION

Call 1-800-406-7984

PRINCIPAL DISPLAY PANEL

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

select brand ® NDC 15127-979-10 NON-DROWSY * Original Prescription Strength Allergy Relief Tablets Loratadine Orally Disintegrating Tablets, 10 mg Antihistamine 24 Hour Allergy Relief Indoor & Outdoor Allergies No Water Needed Melts in Your Mouth Relief of: Sneezing; Runny Nose; Itchy, Watery Eyes; Itchy Throat or Nose For Adults & Children six years & older! 10 Orally Disintegrating Tablets ٭ Compare to the active ingredient of Claritin ® RediTabs ® * When taken as directed. See Drug Facts Panel. Distributed by: SELECT BRAND ® DISTRIBUTORS 5079375/R0610

Source Document

Official SPL XML cached by FDA.report · DailyMed PDF

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Legacy File Index

FolderFileDate
otca90cd258-ffa6-44e9-aaa0-04bdae94487e.xml2012-10-16
otcLoraODT.jpg2012-10-16