365 WHOLE FOODS MARKET LORATADINE- loratadine tablet

365 Whole Foods Market Loratadine by

Drug Labeling and Warnings

365 Whole Foods Market Loratadine by is a Otc medication manufactured, distributed, or labeled by Whole Foods Market, Inc., Aurohealth LLC, Aurobindo Pharma Limited. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Drug Facts

Active ingredient (in each tablet)

Loratadine USP 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

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 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 (1-800-222-1222) 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
• store at 20° to 25°C (68° to 77°F)
• protect from excessive moisture

Inactive ingredients

lactose monohydrate, magnesium stearate, pregelatinized starch (maize), sodium starch glycolate.

Questions or comments?

call 1-855-274-4122
 

DISTRIBUTED BY:

WHOLE FOODS MARKET

550 BOWIE STREET, AUSTIN, TX 78703

©2025 WHOLE FOODS MARKET IP, INC.

www.wholefoodsmarket.com

PRODUCT OF INDIA

PACKAGE LABEL-PRINCIPAL DISPLAY PANEL - 10 mg (30 Tablets Container Label)

365

WHOLE FOODS

MARKET

NDC: 42681-0053-1

 Non-

Drowsy*
 

Antihistamine

Allergy Relief

Loratadine
Tablets USP, 10mg

Indoor & Outdoor Allergies
*WHEN TAKEN AS DIRECTED. SEE DRUG FACTS PANEL.

30

TABLETS

PACKAGE LABEL-PRINCIPAL DISPLAY PANEL - 10 mg (30 Tablets Container Carton)

NDC: 42681-0053-1

365

WHOLE FOODS

MARKET

Antihistamine
Allergy Relief
Loratadine
Tablets USP, 10mg

**Compare to the Active Ingredient in Claritin®

 Indoor & Outdoor Allergies
 

Sneezing  |  Runny nose

Itchy, Watery Eyes   |   Itchy Throat or Nose

Non-Drowsy*

24 Hour

     Relief

ACTUAL SIZE

*WHEN TAKEN AS DIRECTED. SEE DRUG FACTS PANEL.

30

TABLETS

INGREDIENTS AND APPEARANCE

365 WHOLE FOODS MARKET LORATADINE 
loratadine tablet

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 42681-0053
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
LACTOSE MONOHYDRATE (UNII: EWQ57Q8I5X)
MAGNESIUM STEARATE (UNII: 70097M6I30)
STARCH, CORN (UNII: O8232NY3SJ)
SODIUM STARCH GLYCOLATE TYPE A POTATO (UNII: 5856J3G2A2)

Product Characteristics
Color	WHITE (White to Off-white)	Score	no score
Shape	ROUND	Size	6mm
Flavor		Imprint Code	39;L
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 42681-0053-1	1 in 1 CARTON	04/25/2025
1		30 in 1 BOTTLE; Type 0: Not a Combination Product
2	NDC: 42681-0053-2	1 in 1 CARTON	04/25/2025
2		90 in 1 BOTTLE; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
ANDA	ANDA208314	04/25/2025

Labeler - Whole Foods Market, Inc. (196175616)

Registrant - Aurohealth LLC (078728447)

Establishment
Name	Address	ID/FEI	Business Operations
Aurobindo Pharma Limited		650381903	ANALYSIS(42681-0053) , MANUFACTURE(42681-0053)