MEDIQUE LORADAMED- loratadine tablet, film coated

MEDIQUE Loradamed by

Drug Labeling and Warnings

MEDIQUE Loradamed by is a Otc medication manufactured, distributed, or labeled by Sportpharm, Inc. dba Sportpharm. 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 useif you have ever had an allergic reaction to this product or any of its ingredients.

Ask a doctor before use if you haveliver or kidney disease.

Your doctor should determine if you need a different dose.

When using this productdo 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).

DOSAGE & ADMINISTRATION

Directions

Adults and children (6 years and over)

1 tablet daily, not more than 1 tablet in 24 hours.

Children under 6 years:

Ask a doctor

Consumer with liver or kidney disease:

Ask a doctor

SPL UNCLASSIFIED SECTION

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

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

* may contain

QUESTIONS

Questions or comments?Call 1-800-634-7680

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

MEDIQUE LORADAMED 
loratadine tablet, film coated

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 85766-117(NDC:47682-203)
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)

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

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 85766-117-50	50 in 1 BOX	12/02/2025
1	NDC: 85766-117-46	1 in 1 PACKET; Type 0: Not a Combination Product
2	NDC: 85766-117-12	10 in 1 BOX	12/02/2025
2	NDC: 85766-117-46	1 in 1 PACKET; Type 0: Not a Combination Product
3	NDC: 85766-117-46	1 in 1 PACKET; Type 0: Not a Combination Product	12/02/2025

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
ANDA	ANDA076134	12/30/2008

Labeler - Sportpharm LLC (125298538)