LORATADINE- loratadine tablet 
GRANULES USA, INC.

----------

Non-Drowsy
Allergy Relief

Loratadine Tablets, USP 10 mg

Antihistamine
Indoor and Outdoor Allergies
Relief of:
.Sneezing
.Runny Nose
.Itchy, Watery Eyes
.Itchy Throat or Nose

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

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.

Directions

■adults and children6 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 between 20° to 25°C (68° to 77°F)

Inactive ingredients

lactose monohydrate, magnesium stearate, sodium starch glycolate and starch maize pregelatinized.

Questions?

contact 1-877-770-3183: Mon-Fri 8:00AM EST to 5:00PM PST

PDP

100ct

LORATADINE 
loratadine tablet
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:69848-019
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
LORATADINE (UNII: 7AJO3BO7QN) (LORATADINE - UNII:7AJO3BO7QN) LORATADINE10 mg
Inactive Ingredients
Ingredient NameStrength
SODIUM STARCH GLYCOLATE TYPE A POTATO (UNII: 5856J3G2A2)  
MAGNESIUM STEARATE (UNII: 70097M6I30)  
LACTOSE MONOHYDRATE (UNII: EWQ57Q8I5X)  
STARCH, CORN (UNII: O8232NY3SJ)  
Product Characteristics
Colorwhite (White to off white) Scoreno score
ShapeROUNDSize6mm
FlavorImprint Code G;10
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:69848-019-10100 in 1 BOTTLE; Type 0: Not a Combination Product07/26/2021
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
ANDAANDA21072207/26/2021
Labeler - GRANULES USA, INC. (137098864)

Revised: 12/2023
Document Id: 0cccbfd2-0ed3-2335-e063-6294a90a47e4
Set id: c3c9bc45-7ed5-abf4-e053-2995a90a40ff
Version: 3
Effective Time: 20231218
 
GRANULES USA, INC.