LORATADINE- loratadine tablet 
BluePoint Laboratories

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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

PACKAGE LABEL- PRINCIPAL DISPLAY PANEL - 10mg (100 Tablets Bottle)

NDC 68001-438-00

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. 100 Tablets

10mg Bottle Label

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

NDC 68001-438-04

#Compare to the active ingredient in claritin®

Non-Drowsy*

Loratadine

Tablets USP 10mg

Antihisamine

Indoor and outdoor allergies

24 Hour

Relief of:

Sneezing

Runny Nose

Itchy, Watery Eyes

Itchy Throat or Nose

*When taken as directed.

See Drug Facts Panel. 30 Tablets

10mg Carton

PACKAGE LABEL-PRINCIPAL DISPLAY PANEL- 10 mg Blister Carton (100 Tablets)

NDC 68001-438-96

#Compare to the active

ingredient in claritin®

Non-Drowsy*

Loratadine

Tablets USP 10mg

Antihisamine

Indoor and outdoor allergies

24 Hour

Relief of:

Sneezing

Runny Nose

Itchy, Watery Eyes

Itchy Throat or Nose

*When taken as directed.

See Drug Facts Panel. 100 Tablets

10mg Blister

LORATADINE 
loratadine tablet
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)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:68001-438-001 in 1 CARTON08/26/2020
1100 in 1 BOTTLE; Type 0: Not a Combination Product
2NDC:68001-438-9610 in 1 CARTON08/26/2020
2NDC:68001-438-1610 in 1 BLISTER PACK; Type 0: Not a Combination Product
3NDC:68001-438-041 in 1 CARTON08/26/2020
330 in 1 BOTTLE; Type 0: Not a Combination Product
4NDC:68001-438-971 in 1 CARTON08/26/2020
4300 in 1 BOTTLE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
ANDAANDA20831408/26/2020
Labeler - BluePoint Laboratories (985523874)
Establishment
NameAddressID/FEIBusiness Operations
Aurobindo Pharma Limited650381903analysis(68001-438) , manufacture(68001-438)

Revised: 6/2022
Document Id: e1e021de-1501-2fe3-e053-2a95a90a7be9
Set id: adc506ed-7a7a-facc-e053-2a95a90ae147
Version: 4
Effective Time: 20220620
 
BluePoint Laboratories