Loratadine Allergy Relief

Loratadine Allergy Relief
SPL v4
SPL
SPL Set ID ec08a6ee-3d71-0fa9-e053-2995a90a9cb1
Route
ORAL
Published
Effective Date 2022-10-27
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: RX526 Shape: round Color: white Size: 6 mm Score: 1
Marketing Status
ANDA Active Since 2022-10-01

Description

Drug Facts

Purpose

Antihistamine


Medication Information

Purpose

Antihistamine

Description

Drug Facts

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
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 ifan 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 53414-9

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

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 between 20° to 25° C (68° to 77° F)
  • protect from excessive moisture
  • TAMPER EVIDENT: DO NOT USE IF IMPRINTED SEAL IS BROKEN OR MISSING FROM BOTTLE.
Inactive Ingredients

corn starch, lactose monohydrate, magnesium stearate, pregelatinized starch

Principal Display Panel

Loratadine 10mg Tablets

NDC 10135-0763-30

30 Tablets

Loratadine 10mg Tablets

NDC 10135-0763-90

90 Tablets

Loratadine 10mg Tablets

NDC 10135-0763-03

300 Tablets

Active Ingredient (in Each Tablet)

Loratadine, USP 10 mg


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
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 ifan 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 53414-9 (53414-9)

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

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 between 20° to 25° C (68° to 77° F)
  • protect from excessive moisture
  • TAMPER EVIDENT: DO NOT USE IF IMPRINTED SEAL IS BROKEN OR MISSING FROM BOTTLE.
Inactive Ingredients (Inactive ingredients)

corn starch, lactose monohydrate, magnesium stearate, pregelatinized starch

Principal Display Panel (PRINCIPAL DISPLAY PANEL)

Loratadine 10mg Tablets

NDC 10135-0763-30

30 Tablets

Loratadine 10mg Tablets

NDC 10135-0763-90

90 Tablets

Loratadine 10mg Tablets

NDC 10135-0763-03

300 Tablets

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

Loratadine, USP 10 mg


Advanced Ingredient Data


Raw Label Data

All Sections (JSON)