LORATADINE ALLERGY RELIEF- loratadine tablet 
Bryant Ranch Prepack

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Loratadine Allergy Relief

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 ageask a doctor
consumers with liver or kidney diseaseask a doctor

Other Information

Inactive ingredients

corn starch, lactose monohydrate, magnesium stearate, pregelatinized starch

Questions?

call 1-800-406-7984

Distributed by:
Ohm Laboratories Inc.
New Brunswick, NJ 08901

HOW SUPPLIED

NDC: 71335-0100-1: 20 Tablets in a BOTTLE

NDC: 71335-0100-2: 30 Tablets in a BOTTLE

NDC: 71335-0100-3: 60 Tablets in a BOTTLE

NDC: 71335-0100-4: 14 Tablets in a BOTTLE

NDC: 71335-0100-5: 10 Tablets in a BOTTLE

NDC: 71335-0100-6: 90 Tablets in a BOTTLE

NDC: 71335-0100-7: 28 Tablets in a BOTTLE

NDC: 71335-0100-8: 15 Tablets in a BOTTLE

NDC: 71335-0100-9: 100 Tablets in a BOTTLE

Loratadine 10mg Tablet

Label
LORATADINE ALLERGY RELIEF 
loratadine tablet
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:71335-0100(NDC:51660-526)
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
LORATADINE (UNII: 7AJO3BO7QN) (LORATADINE - UNII:7AJO3BO7QN) LORATADINE10 mg
Inactive Ingredients
Ingredient NameStrength
STARCH, CORN (UNII: O8232NY3SJ)  
LACTOSE MONOHYDRATE (UNII: EWQ57Q8I5X)  
MAGNESIUM STEARATE (UNII: 70097M6I30)  
Product Characteristics
Colorwhite (White to Off White) Scoreno score
ShapeROUNDSize6mm
FlavorImprint Code RX526
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:71335-0100-120 in 1 BOTTLE; Type 0: Not a Combination Product02/12/2018
2NDC:71335-0100-230 in 1 BOTTLE; Type 0: Not a Combination Product02/23/2018
3NDC:71335-0100-360 in 1 BOTTLE; Type 0: Not a Combination Product12/27/2021
4NDC:71335-0100-414 in 1 BOTTLE; Type 0: Not a Combination Product12/27/2021
5NDC:71335-0100-510 in 1 BOTTLE; Type 0: Not a Combination Product02/20/2018
6NDC:71335-0100-690 in 1 BOTTLE; Type 0: Not a Combination Product02/09/2018
7NDC:71335-0100-728 in 1 BOTTLE; Type 0: Not a Combination Product12/27/2021
8NDC:71335-0100-815 in 1 BOTTLE; Type 0: Not a Combination Product12/27/2021
9NDC:71335-0100-9100 in 1 BOTTLE; Type 0: Not a Combination Product12/27/2021
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
ANDAANDA07613411/01/2017
Labeler - Bryant Ranch Prepack (171714327)
Registrant - Bryant Ranch Prepack (171714327)
Establishment
NameAddressID/FEIBusiness Operations
Bryant Ranch Prepack171714327REPACK(71335-0100) , RELABEL(71335-0100)

Revised: 12/2021
Document Id: 40914eeb-3a85-4691-9fb8-2df72ba1f709
Set id: 40914eeb-3a85-4691-9fb8-2df72ba1f709
Version: 4
Effective Time: 20211227
 
Bryant Ranch Prepack