GUARDIAN LORATADINE - loratadine tablet 
Guardian Drug Company

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Guardian Loratadine Tablets

ACTIVE INGREDIENT (in each tablet)

Loratadine USP, 10mg

PURPOSE

Antihistamine

USE(S)

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 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.

IF PREGNANT OR 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 over1 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



SAFETY SEALED: DO NOT USE IF THE IMPRINTED BOTTLE SEAL WITH "SEALED FOR YOUR PROTECTION" IS OPEN OR TORN 

INACTIVE INGREDIENTS

colloidal silicon dioxide, croscarmellose sodium, lactose monohydrate, magnesium stearate

QUESTIONS OR COMMENTS?

call 1-609-860-2600 Hours: 8am-4pm, EST.

PRINCIPAL DISPLAY PANEL

Guardian
NDC 53041-285-21

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



285

GUARDIAN LORATADINE 
loratadine tablet
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:53041-285
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
LORATADINE (UNII: 7AJO3BO7QN) (LORATADINE - UNII:7AJO3BO7QN) LORATADINE10 mg
Inactive Ingredients
Ingredient NameStrength
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
CROSCARMELLOSE SODIUM (UNII: M28OL1HH48)  
LACTOSE MONOHYDRATE (UNII: EWQ57Q8I5X)  
MAGNESIUM STEARATE (UNII: 70097M6I30)  
Product Characteristics
ColorWHITEScoreno score
ShapeROUNDSize6mm
FlavorImprint Code L
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:53041-285-211000 in 1 BOTTLE; Type 0: Not a Combination Product07/22/2019
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
ANDAANDA20756907/22/2019
Labeler - Guardian Drug Company (119210276)
Establishment
NameAddressID/FEIBusiness Operations
Guardian Drug Company119210276MANUFACTURE(53041-285)

Revised: 7/2019
Document Id: af8cdd37-8fd0-4651-ae03-36c7d4863301
Set id: af8cdd37-8fd0-4651-ae03-36c7d4863301
Version: 1
Effective Time: 20190722
 
Guardian Drug Company