ALLERGY RELIEF NON DROWSY- loratadine tablet 
Denton Pharma, Inc. dba Northwind Pharmaceuticals

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Drug Facts

Active ingredient (in each tablet)

Loratadine, USP 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 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 over1 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 at 20º-25ºC (68º-77ºF) (see UPS Controlled Room Temperature)

Inactive ingredients

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

Questions or comments?

Call 1-888-588-1418 Monday-Friday 9AM-5PM EST

Principal Display Panel

NDC: 70934-685-90

label

ALLERGY RELIEF  NON DROWSY
loratadine tablet
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:70934-685(NDC:69230-312)
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
ShapeROUNDSize6mm
FlavorImprint Code GG296
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:70934-685-9090 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product04/29/202012/31/2021
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
ANDAANDA07520904/29/202012/31/2021
Labeler - Denton Pharma, Inc. dba Northwind Pharmaceuticals (080355546)
Registrant - Denton Pharma, Inc. dba Northwind Pharmaceuticals (080355546)
Establishment
NameAddressID/FEIBusiness Operations
Denton Pharma, Inc. dba Northwind Pharmaceuticals080355546repack(70934-685)

Revised: 1/2023
Document Id: f1ec339b-9191-999d-e053-2995a90ac45a
Set id: a9f2a410-8090-8e1a-e053-2995a90aeb32
Version: 2
Effective Time: 20230110
 
Denton Pharma, Inc. dba Northwind Pharmaceuticals