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

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

Drug Labeling and Warnings

Drug Details

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CLARITIN- loratadine tablet 
Bayer HealthCare LLC.

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

Drug Facts

Active ingredient (in each tablet)

Loratadine 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 right away.

Directions

adults and children 6 years and over1 tablet daily; not more than 1 tablet in 24 hours
children under 6 years of ageask a doctor
consumers with liver or kidney diseaseask a doctor

Other information (Blister foil units)

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

Other information (Bottles)

  • 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)

Inactive ingredients

corn starch, lactose monohydrate, magnesium stearate

Questions or comments?

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

PRINCIPAL DISPLAY PANEL - 10 Tablet 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.

10 Tablets

10 count carton

PRINCIPAL DISPLAY PANEL - 45 Count Window Box

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.

45 TABLETS

Carton box 45

PRINCIPAL DISPLAY PANEL - 50 Tablet Carton

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.

50 1-Count Pouches

Total 50 Tablets

Dump bin 1Dump bin 2

CLARITIN 
loratadine tablet
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC: 11523-7237
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 Code 458;Claritin10
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC: 11523-7237-11 in 1 CARTON04/12/1993
145 in 1 BOTTLE; Type 0: Not a Combination Product
2NDC: 11523-7237-37 in 1 CARTON08/12/1993
210 in 1 BLISTER PACK; Type 0: Not a Combination Product
3NDC: 11523-7237-51 in 1 BLISTER PACK04/12/1993
390 in 1 BOTTLE; Type 0: Not a Combination Product
4NDC: 11523-7237-63 in 1 CARTON04/12/1993
45 in 1 BLISTER PACK; Type 0: Not a Combination Product
5NDC: 11523-7237-74 in 1 CARTON04/12/1993
510 in 1 BLISTER PACK; Type 0: Not a Combination Product
6NDC: 11523-7237-81 in 1 CARTON04/12/1993
6108 in 1 BOTTLE; Type 0: Not a Combination Product
7NDC: 11523-7237-91 in 1 CARTON10/05/2017
790 in 1 BOTTLE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
NDANDA01965804/12/1993
CLARITIN 
loratadine tablet
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC: 11523-7160
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 Code 458;Claritin10
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC: 11523-7160-11 in 1 CARTON04/12/1993
15 in 1 BLISTER PACK; Type 0: Not a Combination Product
2NDC: 11523-7160-21 in 1 CARTON04/12/1993
210 in 1 BLISTER PACK; Type 0: Not a Combination Product
3NDC: 11523-7160-32 in 1 CARTON04/12/1993
310 in 1 BLISTER PACK; Type 0: Not a Combination Product
4NDC: 11523-7160-53 in 1 CARTON04/12/1993
410 in 1 BLISTER PACK; Type 0: Not a Combination Product
5NDC: 11523-7160-61 in 1 CARTON04/12/1993
52 in 1 POUCH; Type 0: Not a Combination Product
6NDC: 11523-7160-71 in 1 POUCH04/12/1993
61 in 1 BLISTER PACK; Type 0: Not a Combination Product
7NDC: 11523-7160-91 in 1 CARTON04/12/1993
760 in 1 BOTTLE; Type 0: Not a Combination Product
8NDC: 11523-7160-81 in 1 CARTON09/01/2016
860 in 1 BOTTLE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
NDANDA01965804/12/1993
CLARITIN 
loratadine tablet
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC: 11523-1527
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 Code 458;Claritin10
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC: 11523-1527-150 in 1 BOX04/12/1993
11 in 1 POUCH; Type 0: Not a Combination Product
2NDC: 11523-1527-250 in 1 BOX04/12/1993
21 in 1 POUCH; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
NDANDA01965804/12/1993
CLARITIN 
loratadine tablet
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC: 11523-4359
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 Code 458;Claritin10
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC: 11523-4359-11 in 1 CARTON04/12/1993
140 in 1 BOTTLE; Type 0: Not a Combination Product
2NDC: 11523-4359-21 in 1 CARTON04/12/1993
2100 in 1 BOTTLE; Type 0: Not a Combination Product
3NDC: 11523-4359-31 in 1 CARTON11/01/2017
390 in 1 BOTTLE; Type 0: Not a Combination Product
4NDC: 11523-4359-41 in 1 CARTON02/15/2019
455 in 1 BOTTLE; Type 0: Not a Combination Product
5NDC: 11523-4359-51 in 1 CARTON02/15/2019
585 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)

Revised: 2/2019
 
Bayer HealthCare LLC.


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