Drug Facts

Drug Facts
SPL v1
SPL
SPL Set ID c4b5ae13-da50-49d4-a76c-b2b3969596dd
Route
ORAL
Published
Effective Date 2021-03-01
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: GG296 Shape: round Color: white Size: 6 mm Score: 1
Marketing Status
ANDA Active Since 2018-12-31

Description

Loratadine, USP 10 mg

Purpose

Antihistamine

How Supplied

Product: 50090-4266 NDC: 50090-4266-0 30 TABLET in a BOTTLE


Medication Information

Purpose

Antihistamine

How Supplied

Product: 50090-4266

NDC: 50090-4266-0 30 TABLET in a BOTTLE

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.

Other Information
  • store at 20º-25ºC (68º-77ºF) (see UPS Controlled Room Temperature)
Inactive Ingredients

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

Questions Or Comments?

Call 1-888-588-1418 Monday-Friday 9AM-5PM EST

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)

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.

Allergy Relief Non Drowsy (loratadine) Tablet

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.

How Supplied (HOW SUPPLIED)

Product: 50090-4266

NDC: 50090-4266-0 30 TABLET in a BOTTLE

Other Information (Other information)
  • store at 20º-25ºC (68º-77ºF) (see UPS Controlled Room Temperature)
Inactive Ingredients (Inactive ingredients)

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

Questions Or Comments? (Questions or comments?)

Call 1-888-588-1418 Monday-Friday 9AM-5PM EST

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 right away (1-800-222-1222)

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.

Allergy Relief Non Drowsy (loratadine) Tablet (ALLERGY RELIEF NON DROWSY (LORATADINE) TABLET)

Advanced Ingredient Data


Raw Label Data

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