LORATADINE ANTIHISTAMINE- loratadine tablet 
REMEDYREPACK INC.

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Perrigo Loratadine Tablets, 10 mg Drug Facts

Active ingredient (in each tablet)

Loratadine 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. (1-800-222-1222)

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)

Inactive ingredients

lactose monohydrate, magnesium stearate, povidone, pregelatinized starch

Questions or comments?

1-800-719-9260

DRUG: Loratadineantihistamine antihistamine

GENERIC: Loratadine

DOSAGE: TABLET

ADMINSTRATION: ORAL

NDC: 70518-0135-0

NDC: 70518-0135-1

NDC: 70518-0135-2

NDC: 70518-0135-3

NDC: 70518-0135-4

NDC: 70518-0135-5

COLOR: white

SHAPE: OVAL

SCORE: No score

SIZE: 8 mm

IMPRINT: L612

PACKAGING: 30 in 1 BLISTER PACK

PACKAGING: 20 in 1 BOTTLE PLASTIC

PACKAGING: 7 in 1 BLISTER PACK

PACKAGING: 100 in 1 BOTTLE PLASTIC

PACKAGING: 30 in 1 BOTTLE PLASTIC

PACKAGING: 90 in 1 BOTTLE PLASTIC

ACTIVE INGREDIENT(S):

  • LORATADINE 10mg in 1

INACTIVE INGREDIENT(S):

  • POVIDONE, UNSPECIFIED
  • MAGNESIUM STEARATE
  • LACTOSE MONOHYDRATE

MM5

LORATADINE  ANTIHISTAMINE
loratadine tablet
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:70518-0135(NDC:45802-650)
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:70518-0135-030 in 1 BLISTER PACK; Type 0: Not a Combination Product01/17/201707/31/2017
2NDC:70518-0135-120 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product02/02/201704/23/2017
3NDC:70518-0135-27 in 1 BLISTER PACK; Type 0: Not a Combination Product02/07/201707/13/2017
4NDC:70518-0135-3100 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product03/03/201712/04/2019
5NDC:70518-0135-430 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product08/03/201710/10/2023
6NDC:70518-0135-590 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product09/27/201709/27/2017
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
ANDAANDA07630101/17/201710/10/2023
Labeler - REMEDYREPACK INC. (829572556)

Revised: 12/2023
Document Id: 0bd8de3d-0b5f-16f5-e063-6294a90a5b8d
Set id: 56e9833e-df0f-4140-a36a-c6bf72e763b0
Version: 18
Effective Time: 20231206
 
REMEDYREPACK INC.