LORATADINE- loratadine tablet 
Rising Pharmaceuticals, Inc

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Loratadine

Drug Facts

Active Ingredient (in each tablet)

Loratadine, 10 mg USP

Purpose

Antihistamine

Uses

Temporarily relieves these symptoms due to hay fever or other respiratory allergies:

Warnings

Do not use if you ever have 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 pregnanct 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 of age 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

Inactive ingredients corn starch, lactose monohydrate, magnesium stearate, povidone

Questions or comments?

Call 1-800-874-7464 Monday to Friday 9 AM to 5 PM EST

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

30 Count Container Label

30-Count-Label

30ctback

100 Count Container Label

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LORATADINE 
loratadine tablet
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:16571-822
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 (UNII: FZ989GH94E)  
STARCH, CORN (UNII: O8232NY3SJ)  
Product Characteristics
Colorwhite (white to off-white) Scoreno score
ShapeROUNDSize6mm
FlavorImprint Code 10;p
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:16571-822-01100 in 1 BOTTLE; Type 0: Not a Combination Product03/10/2022
2NDC:16571-822-0330 in 1 BOTTLE; Type 0: Not a Combination Product03/10/2022
3NDC:16571-822-30300 in 1 BOTTLE; Type 0: Not a Combination Product03/10/2022
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
ANDAANDA21468403/10/2022
Labeler - Rising Pharmaceuticals, Inc (835513529)
Registrant - Unique Pharmaceuticals Laboratories (650434645)
Establishment
NameAddressID/FEIBusiness Operations
Unique Pharmaceuticals Laboratories650434645manufacture(16571-822)

Revised: 3/2022
Document Id: 8b088034-c702-4b88-b4e3-421aa9739ec8
Set id: d28128a3-af54-440e-9bd4-0fccf393d18a
Version: 1
Effective Time: 20220310
 
Rising Pharmaceuticals, Inc