Loratadine Tablets USP 10 mg

Loratadine Tablets USP 10 mg

Drug Labeling and Warnings

Drug Details

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LORATADINE - loratadine tablet 
Aurohealth LLC

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Loratadine Tablets USP 10 mg

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:


  • runny nose                                                                    
  • itchy, watery eyes
  • sneezing 
  • itching of the nose or throat

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 (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


  • Tamper-evident: do not use if foil seal under cap, printed with “SEALED for YOUR PROTECTION” is missing, open or broken
  • store at 20° to 25°C (68° to 77°F)
  • protect from excessive moisture

Inactive ingredients

lactose monohydrate, magnesium stearate, pregelatinized starch (maize), sodium starch glycolate.

Questions or comments?


call 1-855-274-4122

Distributed by: AUROHEALTH LLC
2572 Brunswick Pike
Lawrenceville, NJ 08648
 Made in India

Code: TS/DRUGS/22/2009

PACKAGE LABEL-PRINCIPAL DISPLAY PANEL - 10 mg (45 Tablets Bottle)

NDC: 58602-702-17
Non-Drowsy*
Loratadine
Tablets USP 10 mg
Antihistamine

24 Hour
Relief of:

  • Sneezing
  • Runny Nose
  • Itchy, Watery Eyes
  • Itchy Throat or Nose

Indoor & Outdoor
Allergies
*When taken as directed.
See Drug Facts Panel.             45 Tablets



PACKAGE LABEL-PRINCIPAL DISPLAY PANEL - 10 mg (45 Tablets Bottle)

PACKAGE LABEL-PRINCIPAL DISPLAY PANEL - 10 mg Container Carton (45 Tablets)

NDC: 58602-702-17
#Compare to the active
ingredient in claritin®

Non-Drowsy*
Loratadine
Tablets USP 10 mg
Antihistamine
Indoor & Outdoor Allergies

24 Hour
Relief of:

  • Sneezing
  • Runny Nose
  • Itchy, Watery Eyes
  • Itchy Throat or Nose

*When taken as directed
See Drug Facts Panel.             45 Tablets




PACKAGE LABEL-PRINCIPAL DISPLAY PANEL - 10 mg Container Carton (45 Tablets)


PACKAGE LABEL-PRINCIPAL DISPLAY PANEL - 10 mg Blister Carton (30 Tablets)

NDC: 58602-702-84
#Compare to the active
ingredient in claritin®
Non-Drowsy*
Loratadine
Tablets USP 10 mg
Antihistamine
Indoor & Outdoor Allergies

24 Hour
Relief of:

  • Sneezing
  • Runny Nose
  • Itchy, Watery Eyes
  • Itchy Throat or Nose

*When taken as directed.
See Drug Facts Panel.
30 Tablets


PACKAGE LABEL-PRINCIPAL DISPLAY PANEL - 10 mg Blister Carton (30 Tablets)

LORATADINE 
loratadine tablet
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC: 58602-702
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)  
STARCH, CORN (UNII: O8232NY3SJ)  
SODIUM STARCH GLYCOLATE TYPE A POTATO (UNII: 5856J3G2A2)  
Product Characteristics
ColorWHITE (White to Off-white) Scoreno score
ShapeROUNDSize6mm
FlavorImprint Code 39;L
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC: 58602-702-171 in 1 CARTON04/16/2018
145 in 1 BOTTLE; Type 0: Not a Combination Product
2NDC: 58602-702-151 in 1 CARTON04/16/2018
260 in 1 BOTTLE; Type 0: Not a Combination Product
3NDC: 58602-702-191 in 1 CARTON04/16/2018
390 in 1 BOTTLE; Type 0: Not a Combination Product
4NDC: 58602-702-811 in 1 CARTON04/16/2018
4108 in 1 BOTTLE; Type 0: Not a Combination Product
5NDC: 58602-702-321 in 1 CARTON04/16/2018
5180 in 1 BOTTLE; Type 0: Not a Combination Product
6NDC: 58602-702-601 in 1 CARTON04/16/2018
65 in 1 BLISTER PACK; Type 0: Not a Combination Product
7NDC: 58602-702-831 in 1 CARTON04/16/2018
710 in 1 BLISTER PACK; Type 0: Not a Combination Product
8NDC: 58602-702-672 in 1 CARTON04/16/2018
810 in 1 BLISTER PACK; Type 0: Not a Combination Product
9NDC: 58602-702-843 in 1 CARTON04/16/2018
910 in 1 BLISTER PACK; Type 0: Not a Combination Product
10NDC: 58602-702-055 in 1 CARTON04/16/2018
1010 in 1 BLISTER PACK; Type 0: Not a Combination Product
11NDC: 58602-702-091 in 1 CARTON05/03/2019
1130 in 1 BOTTLE; Type 0: Not a Combination Product
12NDC: 58602-702-381 in 1 CARTON05/03/2019
12300 in 1 BOTTLE; Type 0: Not a Combination Product
13NDC: 58602-702-391 in 1 CARTON05/03/2019
13365 in 1 BOTTLE; Type 0: Not a Combination Product
14NDC: 58602-702-441 in 1 CARTON07/26/2019
14400 in 1 BOTTLE; Type 0: Not a Combination Product
15NDC: 58602-702-541 in 1 CARTON10/04/2019
1570 in 1 BOTTLE; Type 0: Not a Combination Product
16NDC: 58602-702-231 in 1 CARTON10/04/2019
16120 in 1 BOTTLE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
ANDAANDA20831404/16/2018
Labeler - Aurohealth LLC (078728447)
Establishment
NameAddressID/FEIBusiness Operations
Aurobindo Pharma Limited650381903ANALYSIS(58602-702) , MANUFACTURE(58602-702)

Revised: 10/2019
 
Aurohealth LLC


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