LORATADINE ODT- loratadine tablet, orally disintegrating

United States - English - NLM (National Library of Medicine)

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Active ingredient:
LORATADINE (UNII: 7AJO3BO7QN) (LORATADINE - UNII:7AJO3BO7QN)
Available from:
Chain Drug Consortium, LLC
Administration route:
ORAL
Prescription type:
OTC DRUG
Therapeutic indications:
Antihistamine temporarily relieves these symptoms due to hay fever or other upper respiratory allergies: - runny nose - sneezing - itchy, watery eyes - itching of the nose or throat if you have ever had an allergic reaction to this product or any of its ingredients. liver or kidney disease. Your doctor should determine if you need a different dose. an allergic reaction to this product occurs. Seek medical help right away.
Authorization status:
Abbreviated New Drug Application
Authorization number:
68016-088-10

LORATADINE ODT - loratadine tablet, orally disintegrating

Chain Drug Consortium, LLC

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Loratadine Orally Disintegrating Tablets USP 10 mg

Drug Facts

Active ingredient (in each tablet)

Loratadine USP 10 mg

Purpose

Antihistamine

Uses

temporarily relieves these symptoms due to hay fever or other upper respiratory allergies:

runny nose

sneezing

itchy, watery eyes

itching of the nose or throat

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.

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 (1-800-222-1222) right away.

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 information

Phenylketonurics: Contains phenylalanine 2.25 mg per tablet

do not use if the individual blister unit is open or torn

store at 20° to 25°C (68° to 77°F)

use tablet immediately after opening individual blister

Complies with USP test 2 for Disintegration

Inactive ingredients

aspartame, crospovidone, mannitol, microcrystalline cellulose, peppermint, pregelatinized starch

(maize), sodium stearyl fumarate

Questions or comments?

call 1-855-274-4122

PACKAGE LABEL-PRINCIPAL DISPLAY PANEL - 10 mg, Blister Carton 10 Orally

Disintegrating Tablets

NDC 68016-088-10

**Compare to the active ingredient

in Claritin RediTabs

Original Prescription Strength

Non-Drowsy*

Premier Value

Loratadine Orally Disintegrating Tablets USP 10 mg

Allergy Relief

Antihis tamine

Indoor & Outdoor Allergies

No Water Needed Melts in Your Mouth

24 Hour Relief of:

Sneezing

Runny Nose

Itchy, Watery Eyes

Itchy Throat or Nose

10 Orally Disintegrating Tablets

*When taken as directed. See Drug Facts Panel.

®

®

®

LORATADINE ODT

loratadine tablet, orally disintegrating

Product Information

Product T ype

HUMAN OTC DRUG

Ite m Code (Source )

NDC:6 8 0 16 -0 8 8

Route of Administration

ORAL

Chain Drug Consortium, LLC

Active Ingredient/Active Moiety

Ingredient Name

Basis of Strength

Stre ng th

LO RATADINE (UNII: 7AJO3BO7QN) (LORATADINE - UNII:7AJO3BO7QN)

LORATADINE

10 mg

Inactive Ingredients

Ingredient Name

Stre ng th

ASPARTAME (UNII: Z0 H242BBR1)

CRO SPO VIDO NE ( 15 MPA.S AT 5%) (UNII: 6 8 40 19 6 0 MK)

MANNITO L (UNII: 3OWL53L36 A)

MICRO CRYSTALLINE CELLULO SE (UNII: OP1R32D6 1U)

PEPPERMINT (UNII: V9 5R5KMY2B)

STARCH, CO RN (UNII: O8 232NY3SJ)

SO DIUM STEARYL FUMARATE (UNII: 7CV7WJK4UI)

Product Characteristics

Color

WHITE (White to Off-white)

S core

no sco re

S hap e

ROUND (Bico nvex)

S iz e

8 mm

Flavor

PEPPERMINT

Imprint Code

Contains

Packag ing

#

Item Code

Package Description

Marketing Start Date Marketing End Date

1

NDC:6 8 0 16 -0 8 8 -

1 in 1 CARTON

0 4/11/20 18

1

10 in 1 BLISTER PACK; Type 0 : No t a Co mbinatio n

Pro duc t

Marketing Information

Marke ting Cate gory

Application Numbe r or Monograph Citation

Marke ting Start Date

Marke ting End Date

ANDA

ANDA20 8 477

0 4/11/20 18

Labeler -

Chain Drug Consortium, LLC (101668460)

Registrant -

Aurohealth LLC (078728447)

Establishment

Name

Ad d re s s

ID/FEI

Busine ss Ope rations

Auro bindo Pharma Limited

6 50 38 19 0 3

ANALYSIS(6 8 0 16 -0 8 8 ) , MANUFACTURE(6 8 0 16 -0 8 8 )

Revised: 10/2019

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