ALLERGY RELIEF- loratadine tablet 
A-S Medication Solutions

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788S (658)

Active ingredient (in each tablet)

Loratadine, USP 10 mg

Purpose

Antihistamine

Uses

temporarily relieves these symptoms due to hay fever and other upper respiratory allergies:

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
12 years and over
1 tablet daily; not more
than 1 tablet in 24 hours
children under 12
years of age
ask a doctor
consumers with liver
or kidney disease
ask a doctor

Other information

Inactive ingredients

lactose monohydrate, magnesium stearate, microcrystalline cellulose, sodium starch glycolate

Questions?

call 1-800-540-3765

HOW SUPPLIED

Product: 50090-6164

NDC: 50090-6164-4 30 TABLET in a BOTTLE

NDC: 50090-6164-5 90 TABLET in a BOTTLE

NDC: 50090-6164-0 10 TABLET in a BOTTLE

loratadine

Label Image
ALLERGY RELIEF 
loratadine tablet
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:50090-6164(NDC:57896-658)
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
LORATADINE (UNII: 7AJO3BO7QN) (LORATADINE - UNII:7AJO3BO7QN) LORATADINE10 mg
Inactive Ingredients
Ingredient NameStrength
SODIUM STARCH GLYCOLATE TYPE A CORN (UNII: AG9B65PV6B)  
LACTOSE MONOHYDRATE (UNII: EWQ57Q8I5X)  
MAGNESIUM STEARATE (UNII: 70097M6I30)  
MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U)  
Product Characteristics
ColorwhiteScoreno score
ShapeROUNDSize6mm
FlavorImprint Code 439
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:50090-6164-010 in 1 BOTTLE; Type 0: Not a Combination Product10/12/2022
2NDC:50090-6164-430 in 1 BOTTLE; Type 0: Not a Combination Product10/12/2022
3NDC:50090-6164-590 in 1 BOTTLE; Type 0: Not a Combination Product10/12/2022
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
ANDAANDA07520902/01/2020
Labeler - A-S Medication Solutions (830016429)
Establishment
NameAddressID/FEIBusiness Operations
A-S Medication Solutions830016429RELABEL(50090-6164) , REPACK(50090-6164)

Revised: 11/2023
Document Id: 18c4408b-5d97-4f06-99fe-c7e8df68bf33
Set id: 210fa77a-e33e-48c4-8228-b1cf3ccb7fa4
Version: 5
Effective Time: 20231101
 
A-S Medication Solutions