MEDI FIRST PLUS ALLERGY RELIEF- loratadine tablet, film coated 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 Unifirst First Aid Corporation, Prestige Packaging. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

SPL UNCLASSIFIED SECTION

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 (1-800-222-1222) right away.

Directions

Adults and children(12 years and older): 1 tablet daily; not more than 1 tablet in 24 hours.

Children under 12 years: Do not give to children under 12 years of age.

Consumers with liver or kidney disease

Ask a doctor before using.

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 ingredients

corn starch, lactose monohydrate, magnesium stearate, pregelatinized starch.

Questions or comments?

Call 1-800-634-7680

Medique Loradamed Label

Collect MediBucks

See inside flap for more details

Medique®

Loradamed

24-Hour Allergy Relief

24-horas alivio a las alergias

Pull to Open

Tire Para Abrir

Non-Drowsy* Allery Relief Loratadine 10mg

No produce somnolencia* alivio a las alergias Loratadina 10mg

Fiebre del Heno / Alergias

Antihistamine Diphenhydramine HCl 25 mg

Packet is not child-resistant

Paquete no resistente a los ninos

50 Tablets

(50 x 1)

* When taken as directed. See Drug Facts panel.

*Cuando se toma como se indica. Ver la informacion del medicamento.

Medi-First Plus Allergy Relief Label

100 Tablets

(100 x 1's)

Medi-First® Plus

24-hour Allery Relief

24-horas alivio a las alergias

Loratadine/Loratadina 10mg

Pull To Open

Tire Para Abrir

Packet is not child reistsssnt

Paquete no resistente a los ninos

Non-Drowsey* Allergy Relief

No produc somnolencia* alivo a las alergias

Compare active ingredient to:

Claritin®®

Registered Trademark of Bayer Corp.

*When taken as directed.

See Drug Facts Panel.

*Cuando se toma como se indica.

Ver la informacion del medicamento.

INGREDIENTS AND APPEARANCE

MEDI FIRST PLUS ALLERGY RELIEF 
loratadine tablet, film coated

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 47682-913
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: 47682-913-33	100 in 1 BOX	04/23/2019
1		1 in 1 PACKET; Type 0: Not a Combination Product
2	NDC: 47682-913-46	1 in 1 PACKET; Type 0: Not a Combination Product	04/23/2019

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
ANDA	ANDA076134	04/23/2019

MEDIQUE LORADAMED 
loratadine tablet, film coated

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	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: 47682-203-50	50 in 1 BOX	12/30/2008
1	NDC: 47682-203-46	1 in 1 PACKET; Type 0: Not a Combination Product
2	NDC: 47682-203-12	10 in 1 BOX	10/13/2016
2	NDC: 47682-203-46	1 in 1 PACKET; Type 0: Not a Combination Product
3	NDC: 47682-203-46	1 in 1 PACKET; Type 0: Not a Combination Product	12/30/2008

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

Labeler - Unifirst First Aid Corporation (832947092)

Establishment
Name	Address	ID/FEI	Business Operations
Prestige Packaging		170837962	relabel(47682-203, 47682-913) , repack(47682-203, 47682-913)