XL - 3 Allergy by Selder, S.A. de C.V. XL - 3 ALLERGY tablet

XL - 3 Allergy by

Drug Labeling and Warnings

XL - 3 Allergy by is a Otc medication manufactured, distributed, or labeled by Selder, S.A. de C.V.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Active ingredient(s)

Loratadine 10mg

Purpose

 Antihistamine

Use(s)

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

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 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 blister unit is torn or open

Inactive ingredients

lactose monohydrate, magnesium stearate, pregelatinized starch, sodium starch glycolate

Questions/Comments

Call 1-888-952-0050 Monday through Friday 9AM - 5PM

Principal Display Panel

XL - 3 Allergy

INGREDIENTS AND APPEARANCE

XL - 3 ALLERGY 
xl - 3 allergy tablet

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 63654-415
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 (UNII: H8AV0SQX4D)

Product Characteristics
Color	white	Score	no score
Shape	ROUND	Size	6mm
Flavor		Imprint Code	G;10
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 63654-415-10	1 in 1 CARTON	04/10/2024
1		10 in 1 BLISTER PACK; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
ANDA	ANDA210722	04/10/2024

Labeler - Selder, S.A. de C.V. (824413629)