LORATADINE ANTIHISTAMINE- loratadine tablet 
Proficient Rx LP

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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

Principal Display Panel

Compare to Claritin® active ingredient

Loratadine Tablets, 10 mg

Antihistamine

24 Hour Relief of:

Sneezing

Runny Nose

Itchy, Watery Eyes

Itchy Throat or Nose

Original Prescription Strength

Non-Drowsy*

*When taken as directed.

See Drug Facts Panel.

Convenient Bottle

Repackaged by:

Proficient Rx LP

Thousand Oaks, CA 91320

actual size

60 TABLETS

Indoor & Outdoor Allergies

63187-601-60
LORATADINE  ANTIHISTAMINE
loratadine tablet
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:63187-601(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:63187-601-1010 in 1 BOTTLE; Type 0: Not a Combination Product08/01/2017
2NDC:63187-601-1414 in 1 BOTTLE; Type 0: Not a Combination Product08/01/2017
3NDC:63187-601-3030 in 1 BOTTLE; Type 0: Not a Combination Product08/01/2017
4NDC:63187-601-6060 in 1 BOTTLE; Type 0: Not a Combination Product08/01/2017
5NDC:63187-601-9090 in 1 BOTTLE; Type 0: Not a Combination Product08/01/2017
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
ANDAANDA07630110/15/2008
Labeler - Proficient Rx LP (079196022)
Establishment
NameAddressID/FEIBusiness Operations
Proficient Rx LP079196022REPACK(63187-601) , RELABEL(63187-601)

Revised: 4/2022
Document Id: d36424c7-b438-4c23-884d-d4bfdac81fcf
Set id: e9b87f79-ebed-4677-8e50-00cb4282ee56
Version: 7
Effective Time: 20220401
 
Proficient Rx LP