ALLERGY RELIEF- loratadine tablet LORATADINE 10MG tablet

Loratadine 10mg by

Drug Labeling and Warnings

Loratadine 10mg by is a Otc medication manufactured, distributed, or labeled by Allegiant Health. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Active ingredient (in each tablet)

Loratadine 10mg

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.

Pregnancy/Breastfeeding

ask a health professional before use.

Keep out of reach of children

In case of accidental overdose, contact a doctor or 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

• store between 20° to 25°C (68° to 77°F)
• protect from excessive moisture
• do not use if imprinted seal under safety cap is broken or missing

Inactive ingredients

*corn starch, lactose monohydrate, magnesium stearate ,
pregelantinized starch, *sodium starch glycolate

*May contain these ingredients

Principal Display Panel

Loratadine 10mg

Loratadine 10mg

INGREDIENTS AND APPEARANCE

ALLERGY RELIEF 
loratadine tablet

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 69168-414
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)

Other Ingredients
Ingredient Kind	Ingredient Name	Quantity
May contain	STARCH, CORN (UNII: O8232NY3SJ)
May contain	SODIUM STARCH GLYCOLATE TYPE A (UNII: H8AV0SQX4D)

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

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 69168-414-17	300 in 1 BOTTLE; Type 0: Not a Combination Product	05/01/2020
2	NDC: 69168-414-03	3 in 1 CARTON	05/01/2020
2		10 in 1 BLISTER PACK; Type 0: Not a Combination Product
3	NDC: 69168-414-60	60 in 1 BOTTLE; Type 0: Not a Combination Product	05/18/2022
4	NDC: 69168-414-30	30 in 1 BOTTLE; Type 0: Not a Combination Product	05/01/2020
5	NDC: 69168-414-09	10 in 1 BLISTER PACK; Type 0: Not a Combination Product	05/01/2020
6	NDC: 69168-414-08	5 in 1 BLISTER PACK; Type 0: Not a Combination Product	05/01/2020
7	NDC: 69168-414-02	150 in 1 BOTTLE; Type 0: Not a Combination Product	11/06/2023
8	NDC: 69168-414-99	365 in 1 BOTTLE; Type 0: Not a Combination Product	03/18/2025

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
ANDA	ANDA210722	05/01/2020

LORATADINE 10MG 
loratadine 10mg tablet

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 69168-475
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)

Other Ingredients
Ingredient Kind	Ingredient Name	Quantity
May contain	STARCH, CORN (UNII: O8232NY3SJ)
May contain	SODIUM STARCH GLYCOLATE TYPE A (UNII: H8AV0SQX4D)

Product Characteristics
Color	white	Score	no score
Shape	ROUND	Size	6mm
Flavor		Imprint Code	H;L20
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 69168-475-02	150 in 1 BOTTLE; Type 0: Not a Combination Product	03/18/2025

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
ANDA	ANDA211718	03/18/2025

Labeler - Allegiant Health (079501930)