LORATADINE- loratadine tablet 
Preferred Pharmaceuticals Inc.

----------

Loratadine Tablets USP 10mg

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

itchy, watery eyes

sneezing

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 an 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

Tamper-evident: do not use if foil seal under cap, printed with "SEALED for YOUR PROTECTION" is missing, open or broken

store at 20°C to 25°C (68° to 77°F)

protect from excessive moisture

Inactive ingredients

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

Questions or comments?

call 1-855-274-4122

Manufactured by: Aurobindo Pharma Limited

Hyderabad-509 302,

INDIA

For BluePoint Laboratories

MADE IN INDIA

Code: TS/DRUGS/22/2009

Issued: 04/2020

Repackaged By: Preferred Pharmaceuticals Inc.

PACKAGE LABEL- PRINCIPAL DISPLAY PANEL - 10mg

NDC 68788-8628

Non-Drowsy*

Loratadine

Tablets USP 10mg

Antihistamine

24 Hour

Relief of:

Sneezing

Runny Nose

Itchy, Watery Eyes

Itchy Throat or Nose

Indoor & Outdoor

Allergies

# When taken as directed.

See Drug Facts Panel.

Loratadine Tablets 10mg
LORATADINE 
loratadine tablet
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:68788-8628(NDC:68001-438)
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
LORATADINE (UNII: 7AJO3BO7QN) (LORATADINE - UNII:7AJO3BO7QN) LORATADINE10 mg
Inactive Ingredients
Ingredient NameStrength
MAGNESIUM STEARATE (UNII: 70097M6I30)  
STARCH, CORN (UNII: O8232NY3SJ)  
LACTOSE MONOHYDRATE (UNII: EWQ57Q8I5X)  
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:68788-8628-010 in 1 BOTTLE; Type 0: Not a Combination Product04/11/2024
2NDC:68788-8628-114 in 1 BOTTLE; Type 0: Not a Combination Product04/11/2024
3NDC:68788-8628-515 in 1 BOTTLE; Type 0: Not a Combination Product04/11/2024
4NDC:68788-8628-330 in 1 BOTTLE; Type 0: Not a Combination Product04/11/2024
5NDC:68788-8628-990 in 1 BOTTLE; Type 0: Not a Combination Product04/11/2024
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
ANDAANDA20831404/11/2024
Labeler - Preferred Pharmaceuticals Inc. (791119022)
Registrant - Preferred Pharmaceuticals Inc. (791119022)
Establishment
NameAddressID/FEIBusiness Operations
Preferred Pharmaceuticals Inc.791119022REPACK(68788-8628)

Revised: 4/2024
Document Id: f0d2874f-e60e-4b48-a5c3-db02c34df336
Set id: f0d2874f-e60e-4b48-a5c3-db02c34df336
Version: 1
Effective Time: 20240411
 
Preferred Pharmaceuticals Inc.