Loratadine Tablets USP 10 mg

Loratadine Tablets USP 10 mg

Drug Labeling and Warnings

Drug Details

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LORATADINE - loratadine tablet 
CVS Pharmacy, Inc.

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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:

CVS Pharmacy, Inc.
One CVS Drive
Woonsocket, RI 02895
©2019 CVS/pharmacy
CVS.com®
1-800-SHOP CVS

Made in India
V-31735
CVS Quality
Money Back Guarantee

Code: TS/DRUGS/22/2009

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

CVS HealthTM
NDC69842-242-17
Indoor & Outdoor Allergies
Non-Drowsy*
Allergy Relief
LORATADINE TABLETS U
SP 10 mg
Antihistamine
24 Hours 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 (45 Tablets Bottle)

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

CVS HealthTM
Compare to the active
ingredient in Claritin® Tablets**
Indoor & Outdoor Allergies
NDC: 69842-242-17
Non-Drowsy*
Allergy Relief
LORATADINE TABLETS
USP 10 mg
Antihistamine
24 Hour

Relief of:

  • Sneezing
  • Runny nose
  • Itchy, watery eyes
  • Itchy throat or nose


Actual Bottle Size
on Side Panel

 *When taken as directed.
See Drug Facts Panel.            
45 Tablets              Actual Size
PACKAGE LABEL-PRINCIPAL DISPLAY PANEL - 10 mg Container Carton (45 Tablets)

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

CVS HealthTM
Compare to the active
ingredient in Claritin® Tablets**
Indoor & Outdoor Allergies
NDC: 69842-242-91
Non-Drowsy*
Allergy Relief
LORATADINE TABLETS
USP 10 mg
Antihistamine
24 Hour

Relief of:

 

  • Sneezing
  • Runny nose
  • Itchy, watery eyes
  • Itchy throat or nose

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



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

LORATADINE 
loratadine tablet
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC: 69842-242
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: 69842-242-171 in 1 CARTON08/26/2019
145 in 1 BOTTLE; Type 0: Not a Combination Product
2NDC: 69842-242-541 in 1 CARTON08/26/2019
270 in 1 BOTTLE; Type 0: Not a Combination Product
3NDC: 69842-242-191 in 1 CARTON08/26/2019
390 in 1 BOTTLE; Type 0: Not a Combination Product
4NDC: 69842-242-452 in 1 CARTON08/26/2019
4120 in 1 BOTTLE; Type 0: Not a Combination Product
5NDC: 69842-242-39365 in 1 BOTTLE; Type 0: Not a Combination Product08/26/2019
6NDC: 69842-242-601 in 1 CARTON08/26/2019
65 in 1 BLISTER PACK; Type 0: Not a Combination Product
7NDC: 69842-242-831 in 1 CARTON08/26/2019
710 in 1 BLISTER PACK; Type 0: Not a Combination Product
8NDC: 69842-242-672 in 1 CARTON08/26/2019
810 in 1 BLISTER PACK; Type 0: Not a Combination Product
9NDC: 69842-242-093 in 1 CARTON08/26/2019
910 in 1 BLISTER PACK; Type 0: Not a Combination Product
10NDC: 69842-242-913 in 1 CARTON08/26/2019
1010 in 1 BLISTER PACK; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
ANDAANDA20831408/26/2019
Labeler - CVS Pharmacy, Inc. (062312574)
Registrant - Aurohealth LLC (078728447)
Establishment
NameAddressID/FEIBusiness Operations
Vasudha Pharma Chem Ltd.725431626API MANUFACTURE(69842-242)
Establishment
NameAddressID/FEIBusiness Operations
Aurobindo Pharma Limited650381903ANALYSIS(69842-242) , MANUFACTURE(69842-242)

Revised: 11/2019
 
CVS Pharmacy, Inc.


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