LORATADINE ODT - loratadine tablet, orally disintegrating 
CVS Pharmacy, Inc.

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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:

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



 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

Inactive ingredients

aspartame, crospovidone, mannitol, microcrystalline cellulose,  peppermint, pregelatinized starch (maize), sodium stearyl fumarate

Questions or comments?

call 1-855-274-4122

Distributed by: CVS Pharmacy, Inc.

one CVS Drive, Woonsocket, Rl 02895

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Made in India

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PACKAGE LABEL-PRINCIPAL DISPLAY PANEL - 10 mg, Blister Carton 10 (1 X 10) Orally Disintegrating Tablets

CVS
Health®

Compare to the active ingredient in Claritin® RediTabs®†
Indoor &Outdoor Allergies
NDC 69842-085-03
Original Prescription Strength
Non-Drowsy*
Allergy Relief
LORTADINE ORALLY DISINTEGRATING
TABLETS USP 10 mg
Antihistamine
No Water Needed Melts in Your Mouth

24 Hour
Relief of:


*When taken as directed. See Drug Facts Panel.
10 TABLETS
10 (1 X 10) Orally Disintegrating Tablets









PACKAGE LABEL-PRINCIPAL DISPLAY PANEL - 10 mg, Blister Carton 10 (1 X 10) Orally Disintegrating Tablets




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

CVS HEALTHTM
NDC XXXX-XXXX
**Compare to the active ingredient in Claritin® RediTabs®**
Indoor &Outdoor Allergies
Original Prescription Strength
Non-Drowsy*
Allergy Relief
Loratadine Orally Disintegrating
Tablets USP 10 mg
Antihistamine
No Water Needed Melts in Your Mouth

24 Hour
Relief of:


*When taken as directed. See Drug Facts Panel.

10 (1 X 10) Orally Disintegrating Tablets



PACKAGE LABEL-PRINCIPAL DISPLAY PANEL - 30 mg, Blister Carton 10 (3 X 10) Orally Disintegrating Tablets
LORATADINE ODT 
loratadine tablet, orally disintegrating
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:69842-085
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
LORATADINE (UNII: 7AJO3BO7QN) (LORATADINE - UNII:7AJO3BO7QN) LORATADINE10 mg
Inactive Ingredients
Ingredient NameStrength
ASPARTAME (UNII: Z0H242BBR1)  
CROSPOVIDONE (120 .MU.M) (UNII: 68401960MK)  
MANNITOL (UNII: 3OWL53L36A)  
MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U)  
PEPPERMINT (UNII: V95R5KMY2B)  
STARCH, CORN (UNII: O8232NY3SJ)  
SODIUM STEARYL FUMARATE (UNII: 7CV7WJK4UI)  
Product Characteristics
ColorWHITE (White to Off-white) Scoreno score
ShapeROUND (Biconvex) Size8mm
FlavorPEPPERMINTImprint Code K;9
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:69842-085-031 in 1 CARTON04/11/2018
110 in 1 BLISTER PACK; Type 0: Not a Combination Product
2NDC:69842-085-093 in 1 CARTON04/11/2018
210 in 1 BLISTER PACK; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
ANDAANDA20847704/11/2018
Labeler - CVS Pharmacy, Inc. (062312574)
Registrant - Aurohealth LLC (078728447)
Establishment
NameAddressID/FEIBusiness Operations
Aurobindo Pharma Limited650381903ANALYSIS(69842-085) , MANUFACTURE(69842-085)

Revised: 7/2023
Document Id: 580a1e22-4b2a-4b87-a799-066a11bc7818
Set id: 37443f0d-bda0-4ddc-a2dd-f3daf495cb40
Version: 5
Effective Time: 20230714
 
CVS Pharmacy, Inc.