LORATADINE - loratadine tablet 
Major Pharmaceuticals

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Loratadine 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

lactose monohydrate, magnesium stearate, pregelatinized starch (maize), sodium starch glycolate.

Questions or comments?


call 1-855-274-4122

Distributed by:
MAJOR®  PHARMACEUTICALS
Indianapolis, IN 46268
(800) 616-2471
www.majorpharmaceuticals.com

Made in India

PACKAGE LABEL-PRINCIPAL DISPLAY PANEL - 10 mg (30 Tablets Bottle)

MAJOR®

NDC 0904-7426-46

Non-Drowsy*
Loratadine Tablets USP
10 mg
Antihistamine

24 Hour   |    Indoor & Outdoor Allergies

Relief of:

30 Tablets

*When taken as directed. See Drug Facts Panel.

PACKAGE LABEL-PRINCIPAL DISPLAY PANEL - 10 mg (30 Tablets Bottle)

PACKAGE LABEL-PRINCIPAL DISPLAY PANEL - 10 mg Container Carton (30 Tablets)

MAJOR®

NDC 0904-7426-46
Compare to the
active ingredient
in Claritin®†

Non-Drowsy*
Loratadine
Tablets USP
10 mg
Antihistamine

Indoor & Outdoor Allergies
24 Hour

Relief of:

•    Sneezing
•    
Runny Nose
•    Itchy, Watery Eyes
•    Itchy Throat or Nose

30 Tablets

*When taken as directed. See Drug Facts Panel.

PACKAGE LABEL-PRINCIPAL DISPLAY PANEL - 10 mg Container Carton (30 Tablets)

LORATADINE 
loratadine tablet
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:0904-7426
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
LORATADINE (UNII: 7AJO3BO7QN) (LORATADINE - UNII:7AJO3BO7QN) LORATADINE10 mg
Inactive Ingredients
Ingredient NameStrength
LACTOSE MONOHYDRATE (UNII: EWQ57Q8I5X)  
MAGNESIUM STEARATE (UNII: 70097M6I30)  
STARCH, CORN (UNII: O8232NY3SJ)  
SODIUM STARCH GLYCOLATE TYPE A POTATO (UNII: 5856J3G2A2)  
Product Characteristics
ColorWHITE (White to Off-white) Scoreno score
ShapeROUNDSize6mm
FlavorImprint Code 39;L
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:0904-7426-461 in 1 CARTON02/23/2024
130 in 1 BOTTLE; Type 0: Not a Combination Product
2NDC:0904-7426-591 in 1 CARTON02/23/2024
2100 in 1 BOTTLE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
ANDAANDA20831402/23/2024
Labeler - Major Pharmaceuticals (191427277)
Registrant - Aurohealth LLC (078728447)
Establishment
NameAddressID/FEIBusiness Operations
Aurobindo Pharma Limited650381903ANALYSIS(0904-7426) , MANUFACTURE(0904-7426)

Revised: 6/2024
Document Id: 8d4a63eb-4112-4312-93c2-05688ea201b3
Set id: 98e41ae1-677a-4583-9a0a-edba29ebbc30
Version: 2
Effective Time: 20240629
 
Major Pharmaceuticals