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Guardian Loratadine

Medically reviewed by Drugs.com. Last updated on Jul 12, 2021.

Dosage form: tablet
Ingredients: LORATADINE 10mg
Labeler: Guardian Drug Company
NDC Code: 53041-285

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:


  • runny nose
  • sneezing
  • itchy, watery 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.

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
  • Store at 20o to 25oC (68o to 77oF) [See USP Controlled Room Temperature]
  • Protect from excessive moisture


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




GUARDIAN LORATADINE 
loratadine tablet
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:53041-285
Route of AdministrationORALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
LORATADINE (LORATADINE) LORATADINE10 mg
Inactive Ingredients
Ingredient NameStrength
SILICON DIOXIDE 
CROSCARMELLOSE SODIUM 
LACTOSE MONOHYDRATE 
MAGNESIUM STEARATE 
Product Characteristics
ColorWHITEScoreno score
ShapeROUNDSize6mm
FlavorImprint CodeL
Contains    
Packaging
#Item CodePackage Description
1NDC:53041-285-211000 TABLET in 1 BOTTLE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
ANDAANDA20756907/22/2019
Labeler - Guardian Drug Company (119210276)
Establishment
NameAddressID/FEIOperations
Guardian Drug Company119210276MANUFACTURE(53041-285)

 
Guardian Drug Company

Further information

Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.