LORATADINE- loratadine tablet 
Northstar RxLLC

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NorthStar RxLLC Loratadine Tablets Drug Facts

Active ingredient (in each tablet)

Loratadine 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 overdose, get medical help or contact a Poison Control Center right away. (1-800-222-1222)

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

do not use if printed foil under cap is broken or missing
store between 20° to 25°C (68° to 77°F)

Inactive ingredients

lactose monohydrate, magnesium stearate, povidone, pregelatinized starch

Questions or comments?

1-800-206-7821

Principal Display Panel

Compare to active ingredient of Claritin®

Non-Drowsy*

Original Prescription Strength

Loratadine Tablets, USP

10 mg

Antihistamine

Indoor & Outdoor Allergies

24 Hour

Relief of:

• Sneezing

• Runny Nose

• Itchy, Watery Eyes

• Itchy Throat or Nose

Actual Size

*When taken as directed.

See Drug Facts Panel.

NORTHSTARx®

30 Tablets

loratadine image
LORATADINE 
loratadine tablet
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:16714-898
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)  
POVIDONE, UNSPECIFIED (UNII: FZ989GH94E)  
Product Characteristics
ColorWHITEScoreno score
ShapeOVALSize8mm
FlavorImprint Code L612
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:16714-898-011 in 1 CARTON02/20/2019
130 in 1 BOTTLE; Type 0: Not a Combination Product
2NDC:16714-898-021 in 1 CARTON02/20/2019
2100 in 1 BOTTLE; Type 0: Not a Combination Product
3NDC:16714-898-031 in 1 CARTON02/20/2019
3300 in 1 BOTTLE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
ANDAANDA07630102/20/2019
Labeler - Northstar RxLLC (830546433)

Revised: 3/2022
Document Id: c892d447-9219-44ac-b9f0-ac3b05ba76eb
Set id: 6d3bf7ed-60cf-459f-a9be-3b91e4890a42
Version: 3
Effective Time: 20220308
 
Northstar RxLLC