Medi First Plus Allergy Relief (Loratadine) Tablet, Film Coated Medique Loradamed (Loratadine) Tablet, Film Coated [Unifirst First Aid Corporation] -

MEDI FIRST PLUS ALLERGY RELIEF (LORATADINE) TABLET, FILM COATED MEDIQUE LORADAMED (LORATADINE) TABLET, FILM COATED [UNIFIRST FIRST AID CORPORATION]
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NDC	47682-203-12, 47682-203-46, 47682-203-50, 47682-913-33, 47682-913-46
Set ID	32092beb-c177-4b6b-afa4-b4b5d64621f4
Category	HUMAN OTC DRUG LABEL
Packager	Unifirst First Aid Corporation
Generic Name
Product Class
Product Number
Application Number	ANDA076134

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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 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).
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 starch.
QUESTIONS

Questions or comments? Call 1-800-634-7680
Medique Loradamed Label

Medique®

Loradamed

24-Hour Allergy Relief

24-horas alivio a las alergias

Collect MediBucks

See inside flap for more details

Pull to Open

Tire Para Abrir

Antihistamine • Loratadine 10 mg

Antistaminico • Loratadina 10 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

Medi-First® Plus

24-hour Allery Relief

24-horas alivio a las alergias

Loratadine/Loratadina 10mg

100 Tablets

(100 x 1's)

Pull To Open

Tire Para Abrir

Packet is not child reistsssnt

Paquete no resistente a los ninos

Antihistamine | Antistaminico

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

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
LORATADINE (UNII: 7AJO3BO7QN) (LORATADINE - UNII:7AJO3BO7QN)	LORATADINE	10 mg

Ingredient Name	Strength
Inactive Ingredients
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

#	Item Code	Package Description	Marketing Start Date
Packaging
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 Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
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

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
LORATADINE (UNII: 7AJO3BO7QN) (LORATADINE - UNII:7AJO3BO7QN)	LORATADINE	10 mg

Ingredient Name	Strength
Inactive Ingredients
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

#	Item Code	Package Description	Marketing Start Date
Packaging
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