GUARDIAN LORATADINE- loratadine tablet

Guardian Loratadine by

Drug Labeling and Warnings

Guardian Loratadine by is a Otc medication manufactured, distributed, or labeled by Guardian Drug Company. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

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 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

• 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

INGREDIENTS AND APPEARANCE

GUARDIAN LORATADINE 
loratadine tablet

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 53041-285
Route of Administration	ORAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
LORATADINE (UNII: 7AJO3BO7QN) (LORATADINE - UNII:7AJO3BO7QN)	LORATADINE	10 mg

Inactive Ingredients
Ingredient Name	Strength
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
CROSCARMELLOSE SODIUM (UNII: M28OL1HH48)
LACTOSE MONOHYDRATE (UNII: EWQ57Q8I5X)
MAGNESIUM STEARATE (UNII: 70097M6I30)

Product Characteristics
Color	WHITE	Score	no score
Shape	ROUND	Size	6mm
Flavor		Imprint Code	L
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 53041-285-21	1000 in 1 BOTTLE; Type 0: Not a Combination Product	07/22/2019

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
ANDA	ANDA207569	07/22/2019

Labeler - Guardian Drug Company (119210276)

Establishment
Name	Address	ID/FEI	Business Operations
Guardian Drug Company		119210276	MANUFACTURE(53041-285)