LORATADINE by Rugby Laboratories LORATADINE tablet

LORATADINE by

Drug Labeling and Warnings

LORATADINE by is a Otc medication manufactured, distributed, or labeled by Rugby Laboratories. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Active ingredient (in each tablet)

Loratadine, USP 10

Purpose

Antihistamine

Uses

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

Do not use

if you have ever had an allergic reaction to thisproduct 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.

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

• store between 2° and 30°C (36° and 86°F)
• do not use if seal under bottle cap is broken or missing
• protect from excessive moisture

Inactive ingredients

colloidal silicon dioxide, croscarmellose sodium, lactose monohydrate, magnesium stearate, microcrystalline cellulose

Questions or comments? 

Call 1-800-706-5575, weekdays, 8:30am - 5:00pm Eastern Standard Time

Principal Display Panel

Rugby. NDC: 00536-1092-03

Non-Drowsy*

Loratadine Tablets, USP 10 mg

Antihistamine

Indoor & Outdoor Allergies

24 hour

Relief of:

Sneezing Runny Nose 

Itchy, Watery Eyes 

Itchy Throat or Nose

300 mg

INGREDIENTS AND APPEARANCE

LORATADINE 
loratadine tablet

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 0536-1092
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
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
CROSCARMELLOSE SODIUM (UNII: M28OL1HH48)
LACTOSE MONOHYDRATE (UNII: EWQ57Q8I5X)
MAGNESIUM STEARATE (UNII: 70097M6I30)
MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U)

Product Characteristics
Color	WHITE	Score	no score
Shape	OVAL	Size	8mm
Flavor		Imprint Code	LOR;10;APO
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 0536-1092-03	300 in 1 BOTTLE; Type 0: Not a Combination Product	06/23/2016	04/30/2022
2	NDC: 0536-1092-07	30 in 1 BOTTLE; Type 0: Not a Combination Product	06/23/2016	07/31/2020
3	NDC: 0536-1092-11	90 in 1 BOTTLE; Type 0: Not a Combination Product	06/23/2016	07/31/2020
4	NDC: 0536-1092-01	100 in 1 BOTTLE; Type 0: Not a Combination Product	02/08/2017	04/30/2022

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
ANDA	ANDA076471	06/22/2016	04/30/2022

Labeler - Rugby Laboratories (079246066)