Drug Facts

Drug Facts
SPL v2
SPL
SPL Set ID c5acd9d7-2f26-41c5-b369-2122251583ec
Route
ORAL
Published
Effective Date 2024-05-17
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Loratadine (10 mg)
Inactive Ingredients
Lactose Monohydrate Magnesium Stearate Microcrystalline Cellulose Sodium Starch Glycolate Type A Corn

Identifiers & Packaging

Pill Appearance
Imprint: 439 Shape: round Color: white Size: 6 mm Score: 1
Marketing Status
ANDA Active Since 2024-07-31

Description

Loratadine, USP 10 mg

Purpose

Antihistamine


Medication Information

Purpose

Antihistamine

Description

Loratadine, USP 10 mg

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
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


Do Not Use

if you have ever had an allergic reaction to this product or any of its ingredients.

Package Label
QUALITY CHOICE Allergy Relief
Other Information
  • store at 20º-25ºC (68º-77ºF) (see UPS Controlled Room Temperature)
  • protect from light
Inactive Ingredients

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

Questions Or Comments?

Call 1-800-935-2362 Monday-Friday 9AM-5PM EST

Principal Display Panel

†Compare to the Active Ingredient in Claritin® 24 Hour

Original Prescription Strength

Allergy Relief

Loratadine 10 mg Tablets

Antihistamine

Indoor & Outdoor Allergies

Relief of:

Sneezing | Runny nose

Itchy, Watery Eyes

Itchy Throat or Nose

Gluten-Free

24 Hour Allergy |

Non-Drowsy*

Tablets

*when taken as directed, See Drug Facts panel.

†This product is not manufactured or distributed by Bayer Healthcare LLC, distributor of Claritin® 24 Hour

TAMPER EVIDENT: DO NOT USE IF PRINTED SAFETY SEAL UNDER CAP IS BROKEN OR MISSING

KEEP OUTER CARTON FOR COMPLETE WARNINGS AND PRODUCT INFORMATION

Distributed by CDMA Inc.

Novi, MI 48375

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.

Active Ingredient (in Each Tablet)

Loratadine, USP 10 mg

Ask A Doctor Before Use If You Have

liver or kidney disease. Your doctor should determine if you need a different dose.


Structured Label Content

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
Purpose

Antihistamine

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


Do Not Use (Do not use)

if you have ever had an allergic reaction to this product or any of its ingredients.

Package Label
QUALITY CHOICE Allergy Relief
Other Information (Other information)
  • store at 20º-25ºC (68º-77ºF) (see UPS Controlled Room Temperature)
  • protect from light
Inactive Ingredients (Inactive ingredients)

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

Questions Or Comments? (Questions or comments?)

Call 1-800-935-2362 Monday-Friday 9AM-5PM EST

Principal Display Panel

†Compare to the Active Ingredient in Claritin® 24 Hour

Original Prescription Strength

Allergy Relief

Loratadine 10 mg Tablets

Antihistamine

Indoor & Outdoor Allergies

Relief of:

Sneezing | Runny nose

Itchy, Watery Eyes

Itchy Throat or Nose

Gluten-Free

24 Hour Allergy |

Non-Drowsy*

Tablets

*when taken as directed, See Drug Facts panel.

†This product is not manufactured or distributed by Bayer Healthcare LLC, distributor of Claritin® 24 Hour

TAMPER EVIDENT: DO NOT USE IF PRINTED SAFETY SEAL UNDER CAP IS BROKEN OR MISSING

KEEP OUTER CARTON FOR COMPLETE WARNINGS AND PRODUCT INFORMATION

Distributed by CDMA Inc.

Novi, MI 48375

When Using This Product (When using this product)

do not take more than directed. Taking more than directed may cause drowsiness.

Stop Use and Ask a Doctor If (Stop use and ask a doctor if)

 an allergic reaction to this product occurs. Seek medical help right away.

If Pregnant Or Breast Feeding, (If pregnant or breast-feeding,)

 ask a health professional before use.

Keep Out of Reach of Children. (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.

Active Ingredient (in Each Tablet) (Active ingredient (in each tablet))

Loratadine, USP 10 mg

Ask A Doctor Before Use If You Have (Ask a doctor before use if you have)

liver or kidney disease. Your doctor should determine if you need a different dose.


Advanced Ingredient Data


Raw Label Data

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