Non-drowsy*

Non-drowsy*
SPL v9
SPL
SPL Set ID ac32d6f9-f553-4d5c-ad36-575af5ea56de
Route
ORAL
Published
Effective Date 2017-08-04
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

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

Identifiers & Packaging

Pill Appearance
Imprint: 458;Claritin;10 Shape: round Color: white Size: 6 mm Score: 1
Marketing Status
NDA Active Since 1993-04-12

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.

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 product do not take more than directed. Taking more than directed may cause drowsiness.

Section 50569-3

Ask a doctor before use if you have liver or kidney disease. Your doctor should determine if you need a different dose.

Section 50570-1

Do not use if 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

Inactive Ingredients

corn starch, lactose monohydrate, magnesium stearate

Questions of Comments?

1-800-CLARITIN (1-800-252-7484) or www.claritin.com

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

Other information (Blister foil units)

  • safety sealed: do not use if the individual blister unit imprinted with Claritin (R) is open or torn
  • store between 20° to 25° C (68° to 77°F)
  • protect from excessive moisture
Active Ingredient (in Each Tablet)

Loratadine 10 mg

Principal Display Panel 10 Mg Tablet Bottle Carton

Original Prescription



Strength

Non-Drowsy*



Claritin
®



loratadine tablets 10 mg/antihistamine

24 Hour

Relief of:

  • Sneezing
  • Runny Nose
  • Itchy, Watery Eyes
  • Itchy Throat or Nose

Indoor & Outdoor



Allergies

*When taken as directed.



See Drug Facts Panel.

70 TABLETS


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.

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 product do not take more than directed. Taking more than directed may cause drowsiness.

Section 50569-3 (50569-3)

Ask a doctor before use if you have liver or kidney disease. Your doctor should determine if you need a different dose.

Section 50570-1 (50570-1)

Do not use if 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

Inactive Ingredients (Inactive ingredients)

corn starch, lactose monohydrate, magnesium stearate

Questions of Comments? (Questions of comments?)

1-800-CLARITIN (1-800-252-7484) or www.claritin.com

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

Other information (Blister foil units)

  • safety sealed: do not use if the individual blister unit imprinted with Claritin (R) is open or torn
  • store between 20° to 25° C (68° to 77°F)
  • protect from excessive moisture
Active Ingredient (in Each Tablet) (Active ingredient (in each tablet))

Loratadine 10 mg

Principal Display Panel 10 Mg Tablet Bottle Carton (PRINCIPAL DISPLAY PANEL - 10 mg Tablet Bottle Carton)

Original Prescription



Strength

Non-Drowsy*



Claritin
®



loratadine tablets 10 mg/antihistamine

24 Hour

Relief of:

  • Sneezing
  • Runny Nose
  • Itchy, Watery Eyes
  • Itchy Throat or Nose

Indoor & Outdoor



Allergies

*When taken as directed.



See Drug Facts Panel.

70 TABLETS


Advanced Ingredient Data


Raw Label Data

All Sections (JSON)