LORATADINE- loratadine tablet 
Spirit Pharmaceuticals LLC

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Loratadine Tablets, 10 mg

Active ingredient

Loratadine 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 usung 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.

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, povidone, starch maize pregelatinized

Questions or comments? 

1-888-333-9792

DISPLAY PANEL

NON-DROWSY*

Original Prescription Strength

Loratadine Tablets, 10 mg / Antihistamine

Indoor & Outdoor Allergies

24 Hour Relief of: • Sneezing • Runny Nose • Itchy, Watery Eyes • Itchy Throat or Nose

365 Tablets

*When taken as directed

See Drug Facts Panel

image description

LORATADINE 
loratadine tablet
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:68210-4126
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)  
STARCH, CORN (UNII: O8232NY3SJ)  
POVIDONE (UNII: FZ989GH94E)  
MAGNESIUM STEARATE (UNII: 70097M6I30)  
Product Characteristics
Colorwhite (White to off white) Scoreno score
ShapeROUNDSize6mm
FlavorImprint Code P;10
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:68210-4126-1365 in 1 PACKAGE; Type 0: Not a Combination Product04/07/2021
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
ANDAANDA21468404/07/2021
Labeler - Spirit Pharmaceuticals LLC (179621011)

Revised: 11/2022
Document Id: eea1dd7f-6cf4-880e-e053-2995a90adfdd
Set id: 22adc4f4-e881-4253-8080-7ef49151055a
Version: 3
Effective Time: 20221129
 
Spirit Pharmaceuticals LLC