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Claritin Prescribing Information

Package insert / product label
Generic name: loratadine
Dosage form: tablet
Drug class: Antihistamines

Medically reviewed by Drugs.com. Last updated on Aug 24, 2023.

Drug Facts

Active ingredient (in each tablet)

Loratadine 10 mg

Purpose

Antihistamine

Indications and Usage for Claritin

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 right away.

Claritin Dosage and Administration

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

Storage and Handling

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

Other information (Blister foil units)

  • safety sealed: do not use if the individual blister unit imprinted with Claritin (R) is open or torn
  • store between 20° to 25° C (68° to 77°F)
  • protect from excessive moisture

Inactive ingredients

corn starch, lactose monohydrate, magnesium stearate

Questions of comments?

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

PRINCIPAL DISPLAY PANEL - 10 mg Tablet Bottle Carton

Original Prescription

Strength

Non-Drowsy*

Claritin ®

loratadine tablets 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.

70 TABLETS

Window box carton 70 count

CLARITIN
loratadine tablet
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:11523-6655
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
LORATADINE (UNII: 7AJO3BO7QN) (LORATADINE - UNII:7AJO3BO7QN) LORATADINE10 mg
Inactive Ingredients
Ingredient NameStrength
STARCH, CORN (UNII: O8232NY3SJ)
LACTOSE MONOHYDRATE (UNII: EWQ57Q8I5X)
MAGNESIUM STEARATE (UNII: 70097M6I30)
Product Characteristics
ColorwhiteScoreno score
ShapeROUNDSize6mm
FlavorImprint Code458;Claritin;10
Contains
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:11523-6655-11 in 1 POUCH04/12/1993
11 in 1 BLISTER PACK; Type 0: Not a Combination Product
2NDC:11523-6655-21 in 1 CARTON04/12/1993
270 in 1 BOTTLE; Type 0: Not a Combination Product
3NDC:11523-6655-32 in 1 BLISTER PACK04/12/1993
345 in 1 BOTTLE; Type 0: Not a Combination Product
4NDC:11523-6655-41 in 1 BLISTER PACK04/12/1993
4105 in 1 BOTTLE; Type 0: Not a Combination Product
5NDC:11523-6655-61 in 1 BLISTER PACK04/12/1993
5105 in 1 BOTTLE; Type 0: Not a Combination Product
6NDC:11523-6655-725 in 1 BOX04/12/1993
61 in 1 POUCH; Type 0: Not a Combination Product
7NDC:11523-6655-91 in 1 CARTON04/12/1993
780 in 1 BOTTLE; Type 0: Not a Combination Product
8NDC:11523-6655-81 in 1 CARTON04/12/1993
830 in 1 BOTTLE; Type 0: Not a Combination Product
9NDC:11523-6655-51 in 1 CARTON04/12/1993
960 in 1 BOTTLE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
NDANDA01965804/12/1993
Labeler - Bayer HealthCare LLC (112117283)

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