Label: LORATADINE ODT- loratadine tablet, orally disintegrating
- NDC Code(s): 49035-806-03
- Packager: Wal-Mart Stores, Inc.
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: Abbreviated New Drug Application
Drug Label Information
Updated June 11, 2019
If you are a consumer or patient please visit this version.
- Download DRUG LABEL INFO: PDF XML
- Official Label (Printer Friendly)
- Drug Facts
- Active ingredient (in each tablet)
- Purpose
- Uses
- Warnings
- Do not use
- Ask a doctor before use if you have
- When using this product
- Stop use and ask a doctor if
- If pregnant or breast-feeding,
- Keep out of reach of children.
- Directions
- Other information
- Inactive ingredients
- Questions or comments?
-
PACKAGE LABEL-PRINCIPAL DISPLAY PANEL - 10 mg, Blister Carton 10 (1 x 10) Orally Disintegrating Tablets
NDC 49035-806-03
equateTM
Compare to Claritin® RediTabs® active Ingredient**
Children's Non-Drowsy*
LORATADINE ORALLY
DISINTEGRATING
Tablets USP 10 mg
Antihistamine
FOR CHILDREN SIX YEARS OF AGE OR OLDER
Indoor & Outdoor
Allergies
LASTS UP TO
24 HOURS
Relief of:
Sneezing
Runny Nose Dissolves in
Itchy, Watery Eyes Your Mouth
Itchy Throat or Nose
*When taken as directed. Original
See Drug Facts Panel. Prescription Strength
10 (1X10) Orally Disintegrating Tablets
-
INGREDIENTS AND APPEARANCE
LORATADINE ODT
loratadine tablet, orally disintegratingProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:49035-806 Route of Administration ORAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength LORATADINE (UNII: 7AJO3BO7QN) (LORATADINE - UNII:7AJO3BO7QN) LORATADINE 10 mg Inactive Ingredients Ingredient Name Strength ASPARTAME (UNII: Z0H242BBR1) CROSPOVIDONE (15 MPA.S AT 5%) (UNII: 68401960MK) MANNITOL (UNII: 3OWL53L36A) MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U) PEPPERMINT (UNII: V95R5KMY2B) STARCH, CORN (UNII: O8232NY3SJ) SODIUM STEARYL FUMARATE (UNII: 7CV7WJK4UI) 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 Marketing Start Date Marketing End Date 1 NDC:49035-806-03 1 in 1 CARTON 04/11/2018 1 10 in 1 BLISTER PACK; Type 0: Not a Combination Product 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 Business Operations Vasudha Pharma Chem Ltd. 725431626 API MANUFACTURE(49035-806) Establishment Name Address ID/FEI Business Operations Aurobindo Pharma Limited 650381903 ANALYSIS(49035-806) , MANUFACTURE(49035-806)