ALLERGY RELIEF NON DROWSY- loratadine tablet 
Bryant Ranch Prepack

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Drug Facts

Active ingredient (in each tablet)

Loratadine, USP 10 mg

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

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 over1 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, microcrystalline cellulose, sodium starch glycolate

Questions or comments?

Call 1-888-588-1418 Monday-Friday 9AM-5PM EST

HOW SUPPLIED

NDC: 71335-1461-1: 20 Tablets in a BOTTLE

NDC: 71335-1461-2: 30 Tablets in a BOTTLE

NDC: 71335-1461-3: 60 Tablets in a BOTTLE

NDC: 71335-1461-4: 14 Tablets in a BOTTLE

NDC: 71335-1461-5: 10 Tablets in a BOTTLE

NDC: 71335-1461-6: 90 Tablets in a BOTTLE

NDC: 71335-1461-7: 28 Tablets in a BOTTLE

NDC: 71335-1461-8: 15 Tablets in a BOTTLE

NDC: 71335-1461-9: 100 Tablets in a BOTTLE

Loratadine 10mg Tablet

Label
ALLERGY RELIEF  NON DROWSY
loratadine tablet
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:71335-1461(NDC:69230-312)
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)  
MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U)  
SODIUM STARCH GLYCOLATE TYPE A CORN (UNII: AG9B65PV6B)  
Product Characteristics
ColorwhiteScoreno score
ShapeROUNDSize6mm
FlavorImprint Code GG296
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:71335-1461-120 in 1 BOTTLE; Type 0: Not a Combination Product01/03/2020
2NDC:71335-1461-230 in 1 BOTTLE; Type 0: Not a Combination Product01/30/2020
3NDC:71335-1461-360 in 1 BOTTLE; Type 0: Not a Combination Product12/28/2021
4NDC:71335-1461-414 in 1 BOTTLE; Type 0: Not a Combination Product12/28/2021
5NDC:71335-1461-510 in 1 BOTTLE; Type 0: Not a Combination Product05/19/2020
6NDC:71335-1461-690 in 1 BOTTLE; Type 0: Not a Combination Product01/13/2020
7NDC:71335-1461-728 in 1 BOTTLE; Type 0: Not a Combination Product12/28/2021
8NDC:71335-1461-815 in 1 BOTTLE; Type 0: Not a Combination Product12/28/2021
9NDC:71335-1461-9100 in 1 BOTTLE; Type 0: Not a Combination Product12/28/2021
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
ANDAANDA07520912/31/2018
Labeler - Bryant Ranch Prepack (171714327)
Registrant - Bryant Ranch Prepack (171714327)
Establishment
NameAddressID/FEIBusiness Operations
Bryant Ranch Prepack171714327REPACK(71335-1461) , RELABEL(71335-1461)

Revised: 12/2021
Document Id: 0607e8b0-b231-47bb-8133-10d46e7c0ac7
Set id: 0607e8b0-b231-47bb-8133-10d46e7c0ac7
Version: 4
Effective Time: 20211228
 
Bryant Ranch Prepack