OTC Medication Information: Claritin

CLARITIN- loratadine tablet
Select Corporation

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
  • 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 (1-800-222-1222).

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

  • store at 20° to 25°C (68° to 77°F) (see USP Controlled Room Temperature)

Inactive ingredients

lactose monohydrate, magnesium stearate, microcrystalline cellulose, sodium starch glycolate

Questions or comments?

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

Dist by: Bayer HealthCare LLC
Whippany, NJ 07981

PRINCIPAL DISPLAY PANEL — 10 mg Pouch Blister Pack

Non-Drowsy*
Claritin®
loratadine tablets 10 mg/antihistamine

Original Prescription Strength

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.

1 Tablet

PRINCIPAL DISPLAY PANEL -- 10 mg Pouch Blister Pack
(click image for full-size original)
CLARITIN
loratadine tablet
Product Information
Product Type HUMAN OTC DRUG Item Code (Source) NDC:52904-630(NDC:11523-7160)
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
STARCH, CORN
magnesium stearate
Product Characteristics
Color WHITE Score no score
Shape ROUND Size 6mm
Flavor Imprint Code 458;Claritin10
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:52904-630-03 1 POUCH in 1 BLISTER PACK contains a POUCH
1 1 TABLET in 1 POUCH This package is contained within the BLISTER PACK (52904-630-03)
2 NDC:52904-630-20 20 POUCH in 1 CARTON contains a POUCH
2 1 TABLET in 1 POUCH This package is contained within the CARTON (52904-630-20)
3 NDC:52904-630-25 25 POUCH in 1 CARTON contains a POUCH
3 1 TABLET in 1 POUCH This package is contained within the CARTON (52904-630-25)
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
NDA NDA019658 12/15/2011
Labeler — Select Corporation (053805599)

Revised: 06/2022 Select Corporation

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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