Loratadine by CVS Pharmacy, Inc. / Aurohealth LLC / Aurobindo Pharma Limited LORATADINE tablet

Loratadine by

Drug Labeling and Warnings

Loratadine by is a Otc medication manufactured, distributed, or labeled by CVS Pharmacy, Inc., Aurohealth LLC, Aurobindo Pharma Limited. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

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 USP 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 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 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

INGREDIENTS AND APPEARANCE

LORATADINE 
loratadine tablet

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 69842-242
Route of Administration	ORAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
LORATADINE (UNII: 7AJO3BO7QN) (LORATADINE - UNII:7AJO3BO7QN)	LORATADINE	10 mg

Inactive Ingredients
Ingredient Name	Strength
LACTOSE MONOHYDRATE (UNII: EWQ57Q8I5X)
MAGNESIUM STEARATE (UNII: 70097M6I30)
STARCH, CORN (UNII: O8232NY3SJ)
SODIUM STARCH GLYCOLATE TYPE A POTATO (UNII: 5856J3G2A2)

Product Characteristics
Color	WHITE (White to Off-white)	Score	no score
Shape	ROUND	Size	6mm
Flavor		Imprint Code	39;L
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 69842-242-17	1 in 1 CARTON	08/26/2019
1		45 in 1 BOTTLE; Type 0: Not a Combination Product
2	NDC: 69842-242-54	1 in 1 CARTON	08/26/2019
2		70 in 1 BOTTLE; Type 0: Not a Combination Product
3	NDC: 69842-242-19	1 in 1 CARTON	08/26/2019
3		90 in 1 BOTTLE; Type 0: Not a Combination Product
4	NDC: 69842-242-45	2 in 1 CARTON	08/26/2019
4		120 in 1 BOTTLE; Type 0: Not a Combination Product
5	NDC: 69842-242-39	365 in 1 BOTTLE; Type 0: Not a Combination Product	08/26/2019
6	NDC: 69842-242-60	1 in 1 CARTON	08/26/2019
6		5 in 1 BLISTER PACK; Type 0: Not a Combination Product
7	NDC: 69842-242-83	1 in 1 CARTON	08/26/2019
7		10 in 1 BLISTER PACK; Type 0: Not a Combination Product
8	NDC: 69842-242-67	2 in 1 CARTON	08/26/2019
8		10 in 1 BLISTER PACK; Type 0: Not a Combination Product
9	NDC: 69842-242-09	3 in 1 CARTON	08/26/2019
9		10 in 1 BLISTER PACK; Type 0: Not a Combination Product
10	NDC: 69842-242-91	3 in 1 CARTON	08/26/2019
10		10 in 1 BLISTER PACK; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
ANDA	ANDA208314	08/26/2019

Labeler - CVS Pharmacy, Inc. (062312574)

Registrant - Aurohealth LLC (078728447)

Establishment
Name	Address	ID/FEI	Business Operations
Aurobindo Pharma Limited		650381903	ANALYSIS(69842-242) , MANUFACTURE(69842-242)