MCKESSON LORADATINE- loratainde tablet MCKESSON LORATADINE- loratadine 10 mg tablet, film coated

McKesson Loratadine by

Drug Labeling and Warnings

McKesson Loratadine by is a Otc medication manufactured, distributed, or labeled by McKesson Medical Surgical, Unifirst-First Aid Corporation. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

SPL UNCLASSIFIED SECTION

Drug Facts

ACTIVE INGREDIENT

Active ingredient (in each tablet)

Loratadine 10 mg

PURPOSE

Purpose

Antihistamine

INDICATIONS & USAGE

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

Warnings

DO NOT USE

Do not use if you have ever had an allergic reaction to this product or any of its ingredients.

ASK DOCTOR

Ask a doctor before use if you have liver or kidney disease.

Your doctor should determine if you need a different dose.

WHEN USING

When using this product do not take more than directed.

Taking more than directed may cause drowsiness.

STOP USE

Stop use and ask a doctor if

• an allergic reaction to this product occurs. Seek medical help right away.

PREGNANCY OR BREAST FEEDING

If pregnant or breast-feeding, ask a health professional before use.

KEEP OUT OF REACH OF CHILDREN

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.

DOSAGE & ADMINISTRATION

Directions

Adults and children (6 years and older): 1 tablet daily; not more than 1 tablet in 24 hours.

Children under 6 years: Ask a doctor

Consumers with liver or kidney disease: Ask a doctor

OTHER SAFETY INFORMATION

Other information

• store between 68º and 77ºF (20º and 25ºC )
• protect from excessive moisture
• tamper evident sealed packets
• do not use any opened or torn packets

INACTIVE INGREDIENT

Inactive ingredients

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

QUESTIONS

Questions or comments?

Call 1-800-777-4908

PRINCIPAL DISPLAY PANEL

NDC: 68599-4784-6

McKesson

Loratadine 10 mg

Relieves sneezing, runny nose, itching and watering of the eyes due to upper respiratory allergies.

1 per Pack

50 Packs Per Box

MFR # 82478

PRINCIPAL DISPLAY PANEL

NDC: 68599-4785-6

McKesson

Loratadine

10 mg

Removes sneezing, runny nose,itching and watering

of the eyes due to upper respiratory allergies

1 | 50

PER PACK PACKS PER BOX MFR # 82477

INGREDIENTS AND APPEARANCE

MCKESSON LORADATINE 
loratainde tablet

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 68599-4785
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
MAGNESIUM STEARATE (UNII: 70097M6I30)
WATER (UNII: 059QF0KO0R)
LACTOSE MONOHYDRATE (UNII: EWQ57Q8I5X)
STARCH, CORN (UNII: O8232NY3SJ)
SODIUM STARCH GLYCOLATE TYPE A POTATO (UNII: 5856J3G2A2)

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: 68599-4785-6	50 in 1 BOX	07/01/2025
1		1 in 1 PACKET; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
ANDA	ANDA210722	07/01/2025

MCKESSON LORATADINE 
loratadine 10 mg tablet, film coated

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 68599-4784
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)
MAGNESIUM STEARATE (UNII: 70097M6I30)
LACTOSE MONOHYDRATE (UNII: EWQ57Q8I5X)

Product Characteristics
Color	white	Score	no score
Shape	ROUND	Size	6mm
Flavor		Imprint Code	RX;526
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 68599-4784-6	50 in 1 BOX	08/02/2021	09/30/2026
1		1 in 1 PACKET; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
ANDA	ANDA076134	08/02/2021	09/30/2026

Labeler - McKesson Medical Surgical (023904428)

Registrant - Unifirst-First Aid Corporation (832947092)

Establishment
Name	Address	ID/FEI	Business Operations
Granules India limited		918609236	manufacture(68599-4785)