LORATADINEANTIHISTAMINE ANTIHISTAMINE- loratadine tablet

Loratadineantihistamine by

Drug Labeling and Warnings

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

Drug Details [pdf]

OTC - ACTIVE INGREDIENT

Loratadine 10 mg

 

OTC - PURPOSE

Antihistamine

 

INDICATIONS & USAGE

temporarily relieves these symptoms due to hay fever or other upper respiratory allergies:

• runny nose
• sneezing
• itchy, watery eyes
• itching of the nose or throat

 

WARNINGS

if you have ever had an allergic reaction to this product or any of its ingredients

 

liver or kidney disease. Your doctor should determine if you need a different dose.

 

do not take more than directed. Taking more than directed may cause drowsiness.

 

an allergic reaction to this product occurs. Seek medical help right away.

 

ask a health professional before use.

 

In case of overdose, get medical help or contact a Poison Control Center right away.

 

DOSAGE & ADMINISTRATION

• 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

 

STORAGE AND HANDLING

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

 

INACTIVE INGREDIENT

lactose monohydrate, magnesium stearate, povidone, pregelatinized starch

 

OTC - QUESTIONS

1-800-719-9260

 

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL SECTION

DRUG: Loratadineantihistamine antihistamine

GENERIC: Loratadine

DOSAGE: TABLET

ADMINSTRATION: ORAL

NDC: 49349-218-20

ACTIVE INGREDIENT(S):

• LORATADINE 10mg in 1

INACTIVE INGREDIENT(S):

• LACTOSE MONOHYDRATE
• POVIDONE
• MAGNESIUM STEARATE
• STARCH, CORN

COLOR: white

SHAPE: OVAL

SCORE: No score

SIZE: 8 mm

IMPRINT: L612

PACKAGING: 100 in 1 VIAL

INGREDIENTS AND APPEARANCE

LORATADINEANTIHISTAMINE  ANTIHISTAMINE
loratadine tablet

Product Information
Product Type	HUMAN PRESCRIPTION DRUG	Item Code (Source)	NDC: 49349-218(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)
POVIDONE (UNII: FZ989GH94E)
MAGNESIUM STEARATE (UNII: 70097M6I30)
STARCH, CORN (UNII: O8232NY3SJ)

Product Characteristics
Color	white	Score	no score
Shape	OVAL (TABLET)	Size	8mm
Flavor		Imprint Code	L612
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 49349-218-20	100 in 1 VIAL

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
ANDA	ANDA076301	05/20/2013

Labeler - REMEDYREPACK INC. (829572556)