LORATADINE- loratadine tablet 
Major Pharmaceuticals

----------

Major Pharmaceuticals Allergy Drug Facts

Active ingredient (in each tablet)

Loratadine 10 mg

Original Prescription Strength

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)

This unit dose package is not child resistant and is Intended for Institutional Use Only.

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)
Gluten Free

Inactive ingredients

lactose monohydrate, magnesium stearate, povidone, pregelatinized starch

Distributed by:

MAJOR® PHARMACEUTICALS

17177 N Laurel Park Dr., Suite 233

Livonia, MI 48152 USA

Principal Display Panel

Loratadine Tablets

10 mg

100 Tablets

bag label
LORATADINE 
loratadine tablet
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:0904-6852
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
LORATADINE (UNII: 7AJO3BO7QN) (LORATADINE - UNII:7AJO3BO7QN) LORATADINE10 mg
Inactive Ingredients
Ingredient NameStrength
LACTOSE MONOHYDRATE (UNII: EWQ57Q8I5X)  
MAGNESIUM STEARATE (UNII: 70097M6I30)  
POVIDONE, UNSPECIFIED (UNII: FZ989GH94E)  
Product Characteristics
ColorWHITEScoreno score
ShapeOVALSize8mm
FlavorImprint Code L612
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:0904-6852-61100 in 1 CARTON02/21/2005
11 in 1 BLISTER PACK; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
ANDAANDA07630102/21/2005
Labeler - Major Pharmaceuticals (191427277)
Registrant - Major Pharmaceuticals (191427277)

Revised: 3/2019
Document Id: b91498b6-3bf0-411a-a3bf-c82801ad2e8e
Set id: 71271c28-c0dd-4992-a8a9-6d0d57f7498f
Version: 2
Effective Time: 20190314
 
Major Pharmaceuticals