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

Purpose

Antihistamine

How Supplied

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

Description

Loratadine, USP 10 mg


Medication Information

Active Ingredient

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
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


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

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

How Supplied

Product: 50090-4266

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

Description

Loratadine, USP 10 mg

Do Not Use

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

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)

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

Active Ingredient (Active ingredient (in each tablet))

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
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


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

How Supplied (HOW SUPPLIED)

Product: 50090-4266

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

Do Not Use (Do not use)

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

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)

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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