LORATADINE- loratadine tablet 
Granules Pharmaceuticals Inc.

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Loratadine Tablets, 10 mg

ACTIVE INGREDIENT(S)

Loratadine 10 mg

PURPOSE

Antihistamine

USE(S)

temporarily relieves these symptoms due to hay fever or other upper respiratory allergies:

 runny nose


 sneezing

 itchy, water eyes

 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 DOCTOR IF

an allergic reaction to this product occurs. Seek medical help right away.

PREGNANCY/BREASTFEEDING

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

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


Blister Foil Units

safety sealed: do not use if the individual blister unit is open or torn

STORAGE

store between 20º to 25ºC (68º to 77ºF)

INACTIVE INGREDIENTS

Lactose monohydrate, magnesium stearate, sodium starch glycolate and starch maize pregelatinized

QUESTIONS OR COMMENTS

Contact 1-877-770-3183 Mon-Fri 9:00 AM to 4:30 PM EST.

PRINCIPAL DISPLAY PANEL

loratadine-10mg-containerlabel-jpg.jpg

LORATADINE 
loratadine tablet
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:70010-162
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)  
MAGNESIUM STEARATE (UNII: 70097M6I30)  
SODIUM STARCH GLYCOLATE TYPE A POTATO (UNII: 5856J3G2A2)  
Product Characteristics
Colorwhite (White to off white) Scoreno score
ShapeROUNDSize6mm
FlavorImprint Code G;10
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:70010-162-01100 in 1 BOTTLE; Type 0: Not a Combination Product11/17/2021
2NDC:70010-162-34300 in 1 BOTTLE; Type 0: Not a Combination Product05/01/2022
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
ANDAANDA21072201/01/2020
Labeler - Granules Pharmaceuticals Inc. (079825711)

Revised: 1/2023
Document Id: f33cca66-3283-4931-e053-2a95a90a7583
Set id: d15add22-bc2d-9730-e053-2a95a90acd3f
Version: 4
Effective Time: 20230127
 
Granules Pharmaceuticals Inc.