OTC Medication Information: Loratadine

LORATADINE — loratadine tablet
CVS Pharmacy, Inc.

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
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1-800-SHOP CVS
Made in India
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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)
(click image for full-size original)

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)
(click image for full-size original)

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)
(click image for full-size original)
LORATADINE loratadine tablet
Product Information
Product Type HUMAN OTC DRUG Item Code (Source) NDC:69842-242
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
LORATADINE (LORATADINE) LORATADINE 10 mg
Inactive Ingredients
Ingredient Name Strength
LACTOSE MONOHYDRATE
MAGNESIUM STEARATE
STARCH, CORN
SODIUM STARCH GLYCOLATE TYPE A POTATO
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 Multilevel Packaging
1 NDC:69842-242-17 1 BOTTLE in 1 CARTON contains a BOTTLE
1 45 TABLET in 1 BOTTLE This package is contained within the CARTON (69842-242-17)
2 NDC:69842-242-54 1 BOTTLE in 1 CARTON contains a BOTTLE
2 70 TABLET in 1 BOTTLE This package is contained within the CARTON (69842-242-54)
3 NDC:69842-242-19 1 BOTTLE in 1 CARTON contains a BOTTLE
3 90 TABLET in 1 BOTTLE This package is contained within the CARTON (69842-242-19)
4 NDC:69842-242-45 2 BOTTLE in 1 CARTON contains a BOTTLE
4 120 TABLET in 1 BOTTLE This package is contained within the CARTON (69842-242-45)
5 NDC:69842-242-39 365 TABLET in 1 BOTTLE None
6 NDC:69842-242-60 1 BLISTER PACK in 1 CARTON contains a BLISTER PACK
6 5 TABLET in 1 BLISTER PACK This package is contained within the CARTON (69842-242-60)
7 NDC:69842-242-83 1 BLISTER PACK in 1 CARTON contains a BLISTER PACK
7 10 TABLET in 1 BLISTER PACK This package is contained within the CARTON (69842-242-83)
8 NDC:69842-242-67 2 BLISTER PACK in 1 CARTON contains a BLISTER PACK
8 10 TABLET in 1 BLISTER PACK This package is contained within the CARTON (69842-242-67)
9 NDC:69842-242-09 3 BLISTER PACK in 1 CARTON contains a BLISTER PACK
9 10 TABLET in 1 BLISTER PACK This package is contained within the CARTON (69842-242-09)
10 NDC:69842-242-91 3 BLISTER PACK in 1 CARTON contains a BLISTER PACK
10 10 TABLET in 1 BLISTER PACK This package is contained within the CARTON (69842-242-91)
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 Operations
Vasudha Pharma Chem Ltd. 725431626 API MANUFACTURE (69842-242)
Establishment
Name Address ID/FEI Operations
Aurobindo Pharma Limited 650381903 ANALYSIS (69842-242), MANUFACTURE (69842-242)

Revised: 11/2019 CVS Pharmacy, Inc.

Our database comes directly from the FDA’s central repository of drug labels and package inserts under the Structured Product Labeling standard. OTCLabels.com provides the full over the counter products subset of the FDA’s repository. Medication information provided here is not intended as a substitute for direct consultation with a qualified health professional.

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Our database comes directly from the FDA's central repository of drug labels and package inserts under the Structured Product Labeling standard. OTCLabels.com provides the full over the counter products subset of the FDA's repository. Medication information provided here is not intended as a substitute for direct consultation with a qualified health professional.

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