LORATADINE- loratadine tablet 
NuCare Pharmaceuticals, Inc.

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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
  • 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.

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

  • Safety sealed: do not use if the imprinted bottle seal is open or torn (for bottle only).
  • Safety sealed: do not use if open or torn (for blister package only).

  • Store at 20°-25°C (68°-77°F) (see USP Controlled Room Temperature).

Inactive Ingredients

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

Questions or comments?

1-800-525-8747

10-2015M

Sandoz Inc.

Princeton, NJ 08540

10 mg Label

pdp

LORATADINE 
loratadine tablet
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:68071-3203(NDC:0781-5077)
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)  
CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)  
SODIUM STARCH GLYCOLATE TYPE A POTATO (UNII: 5856J3G2A2)  
Product Characteristics
Colorwhite (white to off white) Scoreno score
ShapeROUNDSize6mm
FlavorImprint Code GG296
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:68071-3203-110 in 1 BOTTLE; Type 0: Not a Combination Product05/11/2017
2NDC:68071-3203-414 in 1 BOTTLE; Type 0: Not a Combination Product05/11/2017
3NDC:68071-3203-220 in 1 BOTTLE; Type 0: Not a Combination Product05/11/2017
4NDC:68071-3203-330 in 1 BOTTLE; Type 0: Not a Combination Product05/11/2017
5NDC:68071-3203-77 in 1 BOTTLE; Type 0: Not a Combination Product05/11/2017
6NDC:68071-3203-660 in 1 BOTTLE; Type 0: Not a Combination Product05/11/2017
7NDC:68071-3203-990 in 1 BOTTLE; Type 0: Not a Combination Product05/11/2017
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
ANDAANDA07520901/21/200301/31/2020
Labeler - NuCare Pharmaceuticals, Inc. (010632300)
Establishment
NameAddressID/FEIBusiness Operations
NuCare Pharmaceuticals, Inc.010632300repack(68071-3203)

Revised: 5/2020
Document Id: a515792d-4ac6-c67b-e053-2995a90afac8
Set id: 4f450c60-fadc-4b9a-e054-00144ff8d46c
Version: 2
Effective Time: 20200507
 
NuCare Pharmaceuticals, Inc.