LORATADINE ANTIHISTAMINE- loratadine tablet

Loratadine by

Drug Labeling and Warnings

Loratadine by is a Otc medication manufactured, distributed, or labeled by REMEDYREPACK INC.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

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

10 mg Tablet oval, white, L612 imprint

NDC: 70518-0135-00 30 in 1 BLISTER PACK

NDC: 70518-0135-01 20 in 1 BOTTLE PLASTIC

NDC: 70518-0135-02 7 in 1 BLISTER PACK

NDC: 70518-0135-03 100 in 1 BOTTLE PLASTIC

NDC: 70518-0135-04 30 in 1 BOTTLE PLASTIC

NDC: 70518-0135-05 90 in 1 BOTTLE PLASTIC

Repackaged and Distributed By:

Remedy Repack, Inc.

625 Kolter Dr. Suite #4 Indiana, PA 1-724-465-8762

PRINCIPAL DISPLAY PANEL

DRUG: Loratadineantihistamine antihistamine

GENERIC: Loratadine

DOSAGE: TABLET

ADMINSTRATION: ORAL

NDC: 70518-0135-0

NDC: 70518-0135-1

NDC: 70518-0135-2

NDC: 70518-0135-3

NDC: 70518-0135-4

NDC: 70518-0135-5

COLOR: white

SHAPE: OVAL

SCORE: No score

SIZE: 8 mm

IMPRINT: L612

PACKAGING: 30 in 1 BLISTER PACK

PACKAGING: 20 in 1 BOTTLE PLASTIC

PACKAGING: 7 in 1 BLISTER PACK

PACKAGING: 100 in 1 BOTTLE PLASTIC

PACKAGING: 30 in 1 BOTTLE PLASTIC

PACKAGING: 90 in 1 BOTTLE PLASTIC

ACTIVE INGREDIENT(S):

• LORATADINE 10mg in 1

INACTIVE INGREDIENT(S):

• LACTOSE MONOHYDRATE
• MAGNESIUM STEARATE
• POVIDONE

INGREDIENTS AND APPEARANCE

LORATADINE  ANTIHISTAMINE
loratadine tablet

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 70518-0135(NDC:45802-650)
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 (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: 70518-0135-0	30 in 1 BLISTER PACK; Type 0: Not a Combination Product	01/17/2017	07/31/2018
2	NDC: 70518-0135-1	20 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	02/02/2017
3	NDC: 70518-0135-2	7 in 1 BLISTER PACK; Type 0: Not a Combination Product	02/07/2017	07/13/2018
4	NDC: 70518-0135-3	100 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	03/03/2017
5	NDC: 70518-0135-4	30 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	08/03/2017
6	NDC: 70518-0135-5	90 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	09/27/2017	09/27/2018

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
ANDA	ANDA076301	01/17/2017

Labeler - REMEDYREPACK INC. (829572556)