ALLERGY RELIEF- loratadine tablet 
Allegiant Health

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309 - Health A2Z Allergy Relief

Active ingredient (in each tablet)

Loratadine 10mg

Purpose

 Antihistamine

Uses

temporarily relieves these symptoms due to hay fever or 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.

You may report side effects to 1-888-952-0050.

Pregnancy/Breastfeeding

ask a health professional before use.

Keep out of reach of children

In case of accidental overdose, contact a doctor or Poison Control Center (1-800-222-1222) 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

Inactive ingredients


lactose monohydrate, magnesium stearate, sodium starch glycolate
May contain: microcrystalline cellulose, pregelatinized starch

Principal Display Panel

Loratadine

Loratadine

ALLERGY RELIEF 
loratadine tablet
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:69168-414
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)  
SODIUM STARCH GLYCOLATE TYPE A (UNII: H8AV0SQX4D)  
Other Ingredients
Ingredient KindIngredient NameQuantity
May containMICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U)  
May containSTARCH, CORN (UNII: O8232NY3SJ)  
Product Characteristics
ColorwhiteScoreno score
ShapeROUNDSize6mm
FlavorImprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:69168-414-17300 in 1 BOTTLE; Type 0: Not a Combination Product05/01/2020
2NDC:69168-414-033 in 1 CARTON05/01/2020
210 in 1 BLISTER PACK; Type 0: Not a Combination Product
3NDC:69168-414-6060 in 1 BOTTLE; Type 0: Not a Combination Product05/18/2022
4NDC:69168-414-3030 in 1 BOTTLE; Type 0: Not a Combination Product05/01/2020
5NDC:69168-414-0910 in 1 BLISTER PACK; Type 0: Not a Combination Product05/01/2020
6NDC:69168-414-085 in 1 BLISTER PACK; Type 0: Not a Combination Product05/01/2020
7NDC:69168-414-02150 in 1 BOTTLE; Type 0: Not a Combination Product11/06/2023
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
ANDAANDA21072205/01/2020
Labeler - Allegiant Health (079501930)

Revised: 6/2020
Document Id: 41e9118f-1555-4bf6-81d0-1b29a1e1e35a
Set id: f0db3a13-43e6-4243-9a3a-7808ddd005e1
Version: 6
Effective Time: 20200616
 
Allegiant Health