OTC Medication Information: Claritin

CLARITIN- loratadine tablet, chewable
Bayer HealthCare LLC.

Active ingredient (in each tablet)

Loratadine 5 mg

Purpose

Antihistamine

Uses

temporarily relieves these symptoms due to hay fever or other upper respiratory allergies:

  • runny nose
  • sneezing
  • itchy, watery eyes
  • 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 right away.

Directions

adults and children 6 years and over chew 2 tablets daily; not more than 2 tablets in 24 hours
children 2 to under 6 years of age chew 1 tablet daily; not more than 1 tablet in 24 hours
children under 2 years of age ask a doctor
consumers with liver or kidney disease ask a doctor

Other information

  • phenylketonurics: contains phenylalanine 1.4 mg per tablet
  • safety sealed: do not use if the individual blister unit imprinted with Children’s Claritin® is open or torn
  • store between 20° to 25°C (68° to 77°F)

Inactive ingredients

aspartame, citric acid anhydrous, colloidal silicon dioxide, D&C red No. 27 aluminum lake, FD&C blue No. 2 aluminum lake, flavor, magnesium stearate, mannitol, microcrystalline cellulose, sodium starch glycolate, stearic acid

Questions or comments?

1-800-CLARITIN (1-800-252-7484) or www.claritin.com

Dist by: Bayer HealthCare LLC, Whippany, NJ 07981

Product of Ireland

PRINCIPAL DISPLAY PANEL — 10 Chewable Tablet Blister Pack Carton

NDC 11523-4328-1

ages
2 years
and older

Children’s
Claritin ®

Allergy

loratadine 5 mg/antihistamine

Indoor & Outdoor Allergies

Non-Drowsy* 24 Hour Relief of:

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

10 CHEWABLE TABLETS

Grape
Flavored
Chewables

*When taken as directed. See Drug Facts Panel.

Carton
(click image for full-size original)
Carton 2
(click image for full-size original)
CLARITIN
loratadine tablet, chewable
Product Information
Product Type HUMAN OTC DRUG Item Code (Source) NDC:11523-4328
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
LORATADINE (LORATADINE) LORATADINE 5 mg
Inactive Ingredients
Ingredient Name Strength
ANHYDROUS CITRIC ACID
SILICON DIOXIDE
D&C RED NO. 27
FD&C BLUE NO. 2
ALUMINUM OXIDE
MAGNESIUM STEARATE
MANNITOL
CELLULOSE, MICROCRYSTALLINE
STEARIC ACID
SODIUM STARCH GLYCOLATE TYPE A POTATO
ASPARTAME
Product Characteristics
Color purple (light to medium purple with a slightly speckled and/or mottled appearance) Score no score
Shape ROUND (flat faced beveled edge) Size 10mm
Flavor GRAPE Imprint Code C
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:11523-4328-1 1 BLISTER PACK in 1 CARTON contains a BLISTER PACK
1 10 TABLET, CHEWABLE in 1 BLISTER PACK This package is contained within the CARTON (11523-4328-1)
2 NDC:11523-4328-2 2 BLISTER PACK in 1 CARTON contains a BLISTER PACK
2 10 TABLET, CHEWABLE in 1 BLISTER PACK This package is contained within the CARTON (11523-4328-2)
3 NDC:11523-4328-3 3 BLISTER PACK in 1 CARTON contains a BLISTER PACK
3 10 TABLET, CHEWABLE in 1 BLISTER PACK This package is contained within the CARTON (11523-4328-3)
4 NDC:11523-4328-5 5 BLISTER PACK in 1 CARTON contains a BLISTER PACK
4 10 TABLET, CHEWABLE in 1 BLISTER PACK This package is contained within the CARTON (11523-4328-5)
5 NDC:11523-4328-4 1 BLISTER PACK in 1 POUCH contains a BLISTER PACK
5 2 TABLET, CHEWABLE in 1 BLISTER PACK This package is contained within the POUCH (11523-4328-4)
6 NDC:11523-4328-7 2.5 BLISTER PACK in 1 PACKAGE, COMBINATION contains a BLISTER PACK
6 10 TABLET, CHEWABLE in 1 BLISTER PACK This package is contained within the PACKAGE, COMBINATION (11523-4328-7)
7 NDC:11523-4328-9 4 BLISTER PACK in 1 CARTON contains a BLISTER PACK
7 10 TABLET, CHEWABLE in 1 BLISTER PACK This package is contained within the CARTON (11523-4328-9)
8 NDC:11523-4328-6 50 POUCH in 1 BOX contains a POUCH
8 2 TABLET, CHEWABLE in 1 POUCH This package is contained within the BOX (11523-4328-6)
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
NDA NDA021891 08/23/2006
CLARITIN
loratadine tablet, chewable
Product Information
Product Type HUMAN OTC DRUG Item Code (Source) NDC:11523-4331
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
LORATADINE (LORATADINE) LORATADINE 5 mg
Inactive Ingredients
Ingredient Name Strength
ANHYDROUS CITRIC ACID
SILICON DIOXIDE
MANNITOL
MAGNESIUM STEARATE
ASPARTAME
CELLULOSE, MICROCRYSTALLINE
FD&C BLUE NO. 2
SODIUM STARCH GLYCOLATE TYPE A POTATO
D&C RED NO. 27
STEARIC ACID
ALUMINUM OXIDE
Product Characteristics
Color purple (Light to medium purple with a slightly speckled and/or mottled appearance) Score no score
Shape ROUND (Flat Faced Beveled Edge) Size 10mm
Flavor GRAPE Imprint Code C
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:11523-4331-1 4 BLISTER PACK in 1 CARTON contains a BLISTER PACK
1 10 TABLET, CHEWABLE in 1 BLISTER PACK This package is contained within the CARTON (11523-4331-1)
2 NDC:11523-4331-2 6 BLISTER PACK in 1 CARTON contains a BLISTER PACK
2 10 TABLET, CHEWABLE in 1 BLISTER PACK This package is contained within the CARTON (11523-4331-2)
3 NDC:11523-4331-6 8 BLISTER PACK in 1 CARTON contains a BLISTER PACK
3 10 TABLET, CHEWABLE in 1 BLISTER PACK This package is contained within the CARTON (11523-4331-6)
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
NDA NDA021891 08/23/2006
Labeler — Bayer HealthCare LLC. (112117283)
Establishment
Name Address ID/FEI Operations
Patheon Manufacturing Services LLC 079415560 manufacture (11523-4328)

Revised: 06/2023 Bayer HealthCare LLC.

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.

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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