McKesson Loratadine Tablets 10 mg Drug Facts

Sunmark Loratadine by

Drug Labeling and Warnings

Sunmark Loratadine by is a Otc medication manufactured, distributed, or labeled by A-S Medication Solutions. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

SUNMARK LORATADINE- loratadine tablet 
A-S Medication Solutions

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McKesson Loratadine Tablets 10 mg Drug Facts

Active ingredient (in each tablet)

Loratadine 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. (1-800-222-1222)

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

• do not use if printed foil under cap is broken or missing
• store between 20° to 25°C (68° to 77°F)

Inactive ingredients

lactose monohydrate, magnesium stearate, povidone, pregelatinized starch

Questions or comments?

1-800-719-9260

HOW SUPPLIED

Product: 50090-5506

SUNMARK LORATADINE (LORATADINE) TABLET

SUNMARK LORATADINE 
loratadine tablet

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 50090-5506(NDC: 49348-818)
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)
POVIDONE, UNSPECIFIED (UNII: FZ989GH94E)

Product Characteristics
Color	WHITE	Score	no score
Shape	OVAL	Size	8mm
Flavor		Imprint Code	L612
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 50090-5506-0	10 in 1 CARTON	04/09/2021	12/31/2023
1		1 in 1 BLISTER PACK; Type 0: Not a Combination Product
2	NDC: 50090-5506-4	30 in 1 CARTON	04/09/2021	12/31/2023
2		1 in 1 BLISTER PACK; Type 0: Not a Combination Product
3	NDC: 50090-5506-5	90 in 1 CARTON	04/09/2021	12/31/2023
3		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	ANDA076301	06/21/2007	12/31/2023

Labeler - A-S Medication Solutions (830016429)

Establishment
Name	Address	ID/FEI	Business Operations
A-S Medication Solutions		830016429	RELABEL(50090-5506)

Revised: 9/2024

Document Id: b7248e4a-1dac-4f81-9479-34fe2ed241db

34390-5

Set id: 1e6d52ae-4d59-4fbf-aed9-a8655e3ea7ba

Version: 5

Effective Time: 20240918