Valumeds Loratadine 10mg Non-drowsy 24-hour Allergy Relief

Valumeds Loratadine 10mg Non-drowsy 24-hour Allergy Relief
SPL v2
SPL
SPL Set ID 7a67f879-9df9-4536-8fd5-4b9aed05fb47
Route
ORAL
Published
Effective Date 2024-12-11
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

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

Identifiers & Packaging

Pill Appearance
Imprint: G10 Shape: round Color: white Size: 6 mm Score: 1
Marketing Status
ANDA Active Since 2024-12-24

Description

Loratadine 10 mg

Purpose

Antihistamine


Medication Information

Purpose

Antihistamine

Description

Loratadine 10 mg

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
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

Drug Facts

Other Information
  • Tamper evident: do not use if imprinted seal under cap, printed with "SEALED FOR YOUR PROTECTION" is missing, open or broken
  • store between 20° to 25°C (68° to 77°F)
Package Labeling:

Inactive Ingredients

lactose monohydrate, magnesium stearate, sodium starch glycolate and starch maize pregelatinized

Questions Or Comments?

contact 1-908-242-6108 Mon-Fri 8:00 AM to 5:00 PM 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. (1-800-222-122)

Active Ingredient (in Each Tablet)

Loratadine 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
  • itchy, watery eyes
  • sneezing
  • 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

Drug Facts

Other Information (Other information)
  • Tamper evident: do not use if imprinted seal under cap, printed with "SEALED FOR YOUR PROTECTION" is missing, open or broken
  • store between 20° to 25°C (68° to 77°F)
Package Labeling:

Inactive Ingredients (Inactive ingredients)

lactose monohydrate, magnesium stearate, sodium starch glycolate and starch maize pregelatinized

Questions Or Comments? (Questions or comments?)

contact 1-908-242-6108 Mon-Fri 8:00 AM to 5:00 PM 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. (1-800-222-122)

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

Loratadine 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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