LORATADINE- loratadine tablet 
REMEDYREPACK 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).

  • 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

DRUG: Loratadine

GENERIC: Loratadine

DOSAGE: TABLET

ADMINSTRATION: ORAL

NDC: 70518-0325-0

NDC: 70518-0325-1

NDC: 70518-0325-2

NDC: 70518-0325-3

NDC: 70518-0325-4

COLOR: white

SHAPE: ROUND

SCORE: No score

SIZE: 6 mm

IMPRINT: GG296

PACKAGING: 20 in 1 BOTTLE, PLASTIC

PACKAGING: 7 in 1 BLISTER PACK

PACKAGING: 30 in 1 BLISTER PACK

PACKAGING: 100 in 1 BOTTLE, PLASTIC

PACKAGING: 30 in 1 BOTTLE, PLASTIC

ACTIVE INGREDIENT(S):

  • LORATADINE 10mg in 1

INACTIVE INGREDIENT(S):

  • LACTOSE MONOHYDRATE
  • MICROCRYSTALLINE CELLULOSE
  • MAGNESIUM STEARATE
  • SODIUM STARCH GLYCOLATE TYPE A POTATO

Remedy_Label

MM2

MM3

MM4

MM5

LORATADINE 
loratadine tablet
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:70518-0325(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
MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U)  
SODIUM STARCH GLYCOLATE TYPE A POTATO (UNII: 5856J3G2A2)  
LACTOSE MONOHYDRATE (UNII: EWQ57Q8I5X)  
MAGNESIUM STEARATE (UNII: 70097M6I30)  
Product Characteristics
Colorwhite (white to off white) Scoreno score
ShapeROUNDSize6mm
FlavorImprint Code GG296
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:70518-0325-020 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product03/16/201703/17/2018
2NDC:70518-0325-17 in 1 BLISTER PACK; Type 0: Not a Combination Product09/11/201703/31/2020
3NDC:70518-0325-230 in 1 BLISTER PACK; Type 0: Not a Combination Product09/13/201703/31/2020
4NDC:70518-0325-3100 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product04/03/201803/31/2020
5NDC:70518-0325-430 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product05/01/201803/31/2020
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
ANDAANDA07520903/16/201703/31/2020
Labeler - REMEDYREPACK INC. (829572556)

Revised: 3/2020
Document Id: a22caca8-10f5-ffcb-e053-2a95a90afe95
Set id: 96e1a164-6ee9-4a6c-8b82-8998cb358617
Version: 8
Effective Time: 20200331
 
REMEDYREPACK INC.