OTC Medication Information: Loratadine ODT

LORATADINE ODT — loratadine tablet, orally disintegrating
Wal-Mart Stores, Inc.

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?

DISTRIBUTED BY: Walmart Inc,.
Bentonville, AR 72716
This Product is not manufactured or distributed
by Bayer HealthCare LLC, distributor of claritin® RediTabs®
Manufactured for :
AUROHEALTH LLC
2572 Brunswick Pikg
Lawrenceville, NJ 08684
Manufactured by :
Aurobindo Pharma Limited
Unit- VII (SEZ)
Mahabubnagar (Dt) -509302
India

PACKAGE LABEL-PRINCIPAL DISPLAY PANEL — 10 mg, Blister Carton 30 (3 x 10) Orally Disintegrating Tablets

NDC 49035-806-09

equateTM

Compared to
the active

Ingredient

In Claritin®

RediTabs®**

Non-Drowsy*

Loratadine Orally Disintegrating Dissolves

Tablets USP 10 mg in Your Mouth
Antihistamine

Indoor & Outdoor Allergy Relief

24 Hour Relief Of:

  • Sneezing
  • Runny nose 24
  • Itchy, watery eyes HOUR
  • Itchy throat or nose

Original Prescription Strength

30
*When taken as directed. See Drug Facts Panel. TABLETS (3 x 10) Orally Disintegrating Tablets

PACKAGE LABEL-PRINCIPAL DISPLAY PANEL -- 10 mg, Blister Carton 30 (3 x 10) Orally Disintegrating Tablets
(click image for full-size original)

LORATADINE ODT loratadine tablet, orally disintegrating
Product Information
Product Type HUMAN OTC DRUG Item Code (Source) NDC:49035-806
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
LORATADINE (LORATADINE) LORATADINE 10 mg
Inactive Ingredients
Ingredient Name Strength
ASPARTAME
CROSPOVIDONE (15 MPA.S AT 5%)
MANNITOL
MICROCRYSTALLINE CELLULOSE
PEPPERMINT
STARCH, CORN
SODIUM STEARYL FUMARATE
Product Characteristics
Color WHITE (White to Off-white) Score no score
Shape ROUND (Biconvex) Size 8mm
Flavor PEPPERMINT Imprint Code K;9
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:49035-806-09 3 BLISTER PACK in 1 CARTON contains a BLISTER PACK
1 10 TABLET, ORALLY DISINTEGRATING in 1 BLISTER PACK This package is contained within the CARTON (49035-806-09)
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA208477 04/11/2018
Labeler — Wal-Mart Stores, Inc. (051957769)
Registrant — Aurohealth LLC (078728447)
Establishment
Name Address ID/FEI Operations
Aurobindo Pharma Limited 650381903 ANALYSIS (49035-806), MANUFACTURE (49035-806)

Revised: 11/2022 Wal-Mart Stores, Inc.

Our database comes directly from the FDA’s central repository of drug labels and package inserts under the Structured Product Labeling standard. OTCLabels.com provides the full over the counter products subset of the FDA’s repository. Medication information provided here is not intended as a substitute for direct consultation with a qualified health professional.

Our database comes directly from the FDA's central repository of drug labels and package inserts under the Structured Product Labeling standard. OTCLabels.com provides the full over the counter products subset of the FDA's repository. Medication information provided here is not intended as a substitute for direct consultation with a qualified health professional.

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