Loratadine by Safecor Health, LLC LORATADINE tablet

Loratadine by

Drug Labeling and Warnings

Loratadine by is a Otc medication manufactured, distributed, or labeled by Safecor Health, LLC. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

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 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 of kidney disease:

  ask a doctor

Other information

• TAMPER EVIDENT: DO NOT USE IF BLISTER UNITS ARE
  TORN, BROKEN OR SHOW ANY SIGNS OF TAMPERING.
• Store at 20° to 25°C (68° to 77°F). [See USP Controlled Room Temperature.]
• protect from excessive moisture

Inactive ingredients

Corn starch, lactose monohydrate and magnesium stearate.

Questions or comments?

call 1-800-447-1006

• Serious side effects associated with use of this product may be reported to this number.

Manufactured for:
Mylan Pharmaceuticals Inc.
Morgantown, WV 26505 U.S.A.

Made in India

Code No.: MH/DRUGS/25/NKD/89

Distributed by:
Safecor Health LLC
Rockford, IL 61103 U.S.A.

PRINCIPAL DISPLAY PANEL

PRODUCT PACKAGING

NDC: 48433-064-20

Loratadine
Tablets USP, 10 mg

Antihistamine

Original Prescription StrengthNon-Drowsy*

Indoor and Outdoor Allergies

24 Hour Relief(See Uses section of Patient Information)

*When taken as directed. See Patient Information.

TAMPER EVIDENT: DO NOT USE IF BLISTER UNITS ARE
TORN, BROKEN OR SHOW ANY SIGNS OF TAMPERING.

INGREDIENTS AND APPEARANCE

LORATADINE 
loratadine tablet

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 48433-064(NDC:0378-8880)
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
STARCH, CORN (UNII: O8232NY3SJ)
LACTOSE MONOHYDRATE (UNII: EWQ57Q8I5X)
MAGNESIUM STEARATE (UNII: 70097M6I30)

Product Characteristics
Color	white (white to off-white)	Score	no score
Shape	ROUND	Size	6mm
Flavor		Imprint Code	G;L;10
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 48433-064-20	100 in 1 CARTON	03/24/2026
1	NDC: 48433-064-01	1 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	ANDA076154	03/24/2026

Labeler - Safecor Health, LLC (828269675)