Medique Loradamed

Medique Loradamed
SPL v1
SPL
SPL Set ID d6bf0e68-f87c-49ee-a15d-df7f5bfa6221
Route
ORAL
Published
Effective Date 2025-12-02
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Loratadine (10 mg)
Inactive Ingredients
Lactose Monohydrate Magnesium Stearate Starch, Corn

Identifiers & Packaging

Pill Appearance
Imprint: RX;526 Shape: round Color: white Size: 6 mm Score: 1
Marketing Status
ANDA Active Since 2008-12-30

Description

Drug Facts


Medication Information

Warnings and Precautions

Warnings

Indications and Usage

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
Dosage and Administration

Directions

Adults and children (6 years and over)

1 tablet daily, not more than 1 tablet in 24 hours.

Children under 6 years:

Ask a doctor

Consumer with liver or kidney disease:

Ask a doctor

Description

Drug Facts

Section 42229-5

Drug Facts

Section 50565-1

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).

Section 50566-9

Stop use and ask a doctor if

  • an allergic reaction to this product occurs. Seek medical help right away.
Section 50567-7

When using this productdo not take more than directed.

Taking more than directed may cause drowsiness.

Section 50569-3

Ask a doctor before use if you haveliver or kidney disease.

Your doctor should determine if you need a different dose.

Section 50570-1

Do not useif you have ever had an allergic reaction to this product or any of its ingredients.

Section 51727-6

Inactive ingredients

corn starch*, lactose monohydrate, magnesium stearate, pregelatinized corn starch*, pregelatinized starch*, sodium starch glycolate*

* may contain

Section 53413-1

Questions or comments? Call 1-800-634-7680

Section 53414-9

If pregnant or breast-feeding, ask a health professional before use.

Section 55105-1

Purpose

Antihistamine

Section 55106-9

Active ingredient (in each tablet)

Loratadine 10 mg

Principal Display Panel


Structured Label Content

Indications and Usage (34067-9)

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
Dosage and Administration (34068-7)

Directions

Adults and children (6 years and over)

1 tablet daily, not more than 1 tablet in 24 hours.

Children under 6 years:

Ask a doctor

Consumer with liver or kidney disease:

Ask a doctor

Warnings and Precautions (34071-1)

Warnings

Section 42229-5 (42229-5)

Drug Facts

Section 50565-1 (50565-1)

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).

Section 50566-9 (50566-9)

Stop use and ask a doctor if

  • an allergic reaction to this product occurs. Seek medical help right away.
Section 50567-7 (50567-7)

When using this productdo not take more than directed.

Taking more than directed may cause drowsiness.

Section 50569-3 (50569-3)

Ask a doctor before use if you haveliver or kidney disease.

Your doctor should determine if you need a different dose.

Section 50570-1 (50570-1)

Do not useif you have ever had an allergic reaction to this product or any of its ingredients.

Section 51727-6 (51727-6)

Inactive ingredients

corn starch*, lactose monohydrate, magnesium stearate, pregelatinized corn starch*, pregelatinized starch*, sodium starch glycolate*

* may contain

Section 53413-1 (53413-1)

Questions or comments? Call 1-800-634-7680

Section 53414-9 (53414-9)

If pregnant or breast-feeding, ask a health professional before use.

Section 55105-1 (55105-1)

Purpose

Antihistamine

Section 55106-9 (55106-9)

Active ingredient (in each tablet)

Loratadine 10 mg

Principal Display Panel (PRINCIPAL DISPLAY PANEL)


Advanced Ingredient Data


Raw Label Data

All Sections (JSON)