LORATADINE- loratadine tablet 
GlaxoSmithKline Consumer Healthcare Holdings (US) LLC

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Drug Facts

Active ingredient

Loratadine 10 mg

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 this product or any of its ingredients.

Ask 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 healthcare 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

Directions

Other information

● store at 15-30C (59-86F)

● protect from excessive moisture

● safety sealed: do not use if imprinted blister unit is open or torn

Inactive Ingredients

Lactose monohydrate, magnesium stearate, microcrystalline cellulose, sodium starch glycolate

Package/Label Principal Display Panel

Loratadine PDP
LORATADINE 
loratadine tablet
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:0067-6070
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)  
MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U)  
SODIUM STARCH GLYCOLATE TYPE A CORN (UNII: AG9B65PV6B)  
Product Characteristics
ColorWHITEScoreno score
ShapeROUNDSize5mm
FlavorImprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:0067-6070-101 in 1 CARTON09/30/200411/30/2014
110 in 1 BLISTER PACK; Type 0: Not a Combination Product
2NDC:0067-6070-303 in 1 CARTON09/30/200411/30/2014
230 in 1 BLISTER PACK; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
NDANDA02137509/30/200411/30/2014
Labeler - GlaxoSmithKline Consumer Healthcare Holdings (US) LLC (079944263)

Revised: 1/2018
Document Id: 816a59c0-7179-4266-935f-03f3323fa690
Set id: bd385a9f-f82f-4965-83fd-273c795f9b4f
Version: 2
Effective Time: 20180116
 
GlaxoSmithKline Consumer Healthcare Holdings (US) LLC