Claritin-d ®

Drug Facts

Composition & Product

Active Ingredients

Loratadine (5 mg) Pseudoephedrine (120 mg)

Inactive Ingredients

Croscarmellose Sodium Calcium Phosphate, Dibasic, Anhydrous Hypromelloses Lactose Monohydrate Magnesium Stearate Povidone Titanium Dioxide

Identifiers & Packaging

Pill Appearance

Imprint: Claritin;D;12 Shape: oval Color: white Size: 12 mm Score: 1

Marketing Status

NDA Active Since 2009-12-01

Medication Information

Description

Drug Facts

Uses

temporarily relieves these symptoms due to hay fever or other upper respiratory allergies:
- sneezing
- itchy, watery eyes
- runny nose
- itching of the nose or throat
temporarily relieves nasal congestion due to the common cold, hay fever or other upper respiratory allergies
reduces swelling of nasal passages
temporarily relieves sinus congestion and pressure
temporarily restores freer breathing through the nose

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.
symptoms do not improve within 7 days or are accompanied by a fever
nervousness, dizziness or sleeplessness occurs

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

heart disease
thyroid disease
high blood pressure
diabetes
trouble urinating due to an enlarged prostate gland
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
if you are now taking a prescription monoamine oxidase inhibitor (MAOI) (certain drugs for depression, psychiatric, or emotional conditions, or Parkinson's disease), or for 2 weeks after stopping the MAOI drug. If you do not know if your prescription drug contains an MAOI, ask a doctor or pharmacist before taking this product.

Section 53414-9

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

Section 55105-1

Active ingredient (in each tablet)	Purpose
Loratadine 5 mg	Antihistamine
Pseudoephedrine sulfate 120 mg	Nasal decongestant

Directions

do not divide, crush, chew or dissolve the tablet

adults and children 12 years and over	1 tablet every 12 hours; not more than 2 tablets in 24 hours
children under 12 years of age	ask a doctor
consumers with liver or kidney disease	ask a doctor

Other Information

each tablet contains: calcium 30 mg
safety sealed: do not use if the individual blister unit imprinted with Claritin-D ^® 12 Hour is open or torn
store between 20° to 25°C (68° to 77°F)
keep in a dry place

Inactive Ingredients

croscarmellose sodium, dibasic calcium phosphate, hypromellose, lactose monohydrate, magnesium sterarate, pharmaceutical ink, povidone, titanium dioxide

Questions Or Comments?

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

Principal Display Panel Carton

NDC 11523-7162-1

Non-Drowsy*

Claritin-D ^®

pseudoephedrine sulfate 120 mg/nasal decongestant

loratadine 5 mg/antihistamine

Indoor & Outdoor Allergies

Allergy & Congestion

12

Hour

Relief of:

Nasal & Sinus Congestion

Due to Colds or Allergies

Sneezing; Runny Nose;

Itchy, Watery Eyes;

Itchy Throat or Nose

Due to Allergies

* When taken as directed. See Drug Facts Panel.

10

EXTENDED

RELEASE TABLETS

Structured Label Content

Uses

temporarily relieves these symptoms due to hay fever or other upper respiratory allergies:
- sneezing
- itchy, watery eyes
- runny nose
- itching of the nose or throat
temporarily relieves nasal congestion due to the common cold, hay fever or other upper respiratory allergies
reduces swelling of nasal passages
temporarily relieves sinus congestion and pressure
temporarily restores freer breathing through the nose

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.
symptoms do not improve within 7 days or are accompanied by a fever
nervousness, dizziness or sleeplessness occurs

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

heart disease
thyroid disease
high blood pressure
diabetes
trouble urinating due to an enlarged prostate gland
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
if you are now taking a prescription monoamine oxidase inhibitor (MAOI) (certain drugs for depression, psychiatric, or emotional conditions, or Parkinson's disease), or for 2 weeks after stopping the MAOI drug. If you do not know if your prescription drug contains an MAOI, ask a doctor or pharmacist before taking this product.

Section 53414-9 (53414-9)

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

Section 55105-1 (55105-1)

Active ingredient (in each tablet)	Purpose
Loratadine 5 mg	Antihistamine
Pseudoephedrine sulfate 120 mg	Nasal decongestant

Directions

do not divide, crush, chew or dissolve the tablet

adults and children 12 years and over	1 tablet every 12 hours; not more than 2 tablets in 24 hours
children under 12 years of age	ask a doctor
consumers with liver or kidney disease	ask a doctor

Other Information (Other information)

each tablet contains: calcium 30 mg
safety sealed: do not use if the individual blister unit imprinted with Claritin-D ^® 12 Hour is open or torn
store between 20° to 25°C (68° to 77°F)
keep in a dry place

Inactive Ingredients (Inactive ingredients)

croscarmellose sodium, dibasic calcium phosphate, hypromellose, lactose monohydrate, magnesium sterarate, pharmaceutical ink, povidone, titanium dioxide

Questions Or Comments? (Questions or comments?)

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

Principal Display Panel Carton (PRINCIPAL DISPLAY PANEL - Carton)

NDC 11523-7162-1

Non-Drowsy*

Claritin-D ^®

pseudoephedrine sulfate 120 mg/nasal decongestant

loratadine 5 mg/antihistamine

Indoor & Outdoor Allergies

Allergy & Congestion

12

Hour

Relief of:

Nasal & Sinus Congestion

Due to Colds or Allergies

Sneezing; Runny Nose;

Itchy, Watery Eyes;

Itchy Throat or Nose

Due to Allergies

* When taken as directed. See Drug Facts Panel.

10

EXTENDED

RELEASE TABLETS

Advanced Ingredient Data

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Raw Label Data

All Sections (JSON)

{"Uses": "temporarily relieves these symptoms due to hay fever or other upper respiratory allergies: sneezing itchy, watery eyes runny nose itching of the nose or throat temporarily relieves nasal congestion due to the common cold, hay fever or other upper respiratory allergies reduces swelling of nasal passages temporarily relieves sinus congestion and pressure temporarily restores freer breathing through the nose", "42229-5": "Drug Facts", "50565-1": "Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center right away.", "50566-9": "Stop use and ask a doctor if an allergic reaction to this product occurs. Seek medical help right away. symptoms do not improve within 7 days or are accompanied by a fever nervousness, dizziness or sleeplessness occurs", "50567-7": "When using this product do not take more than directed. Taking more than directed may cause drowsiness.", "50569-3": "Ask a doctor before use if you have heart disease thyroid disease high blood pressure diabetes trouble urinating due to an enlarged prostate gland liver or kidney disease. Your doctor should determine if you need a different dose.", "50570-1": "Do not use if you have ever had an allergic reaction to this product or any of its ingredients if you are now taking a prescription monoamine oxidase inhibitor (MAOI) (certain drugs for depression, psychiatric, or emotional conditions, or Parkinson's disease), or for 2 weeks after stopping the MAOI drug. If you do not know if your prescription drug contains an MAOI, ask a doctor or pharmacist before taking this product.", "53414-9": "If pregnant or breast-feeding, ask a health professional before use.", "55105-1": "Active ingredient (in each tablet) Purpose Loratadine 5 mg Antihistamine Pseudoephedrine sulfate 120 mg Nasal decongestant", "Directions": "do not divide, crush, chew or dissolve the tablet adults and children 12 years and over 1 tablet every 12 hours; not more than 2 tablets in 24 hours children under 12 years of age ask a doctor consumers with liver or kidney disease ask a doctor", "Other information": "each tablet contains: calcium 30 mg safety sealed: do not use if the individual blister unit imprinted with Claritin-D ® 12 Hour is open or torn store between 20° to 25°C (68° to 77°F) keep in a dry place", "Inactive ingredients": "croscarmellose sodium, dibasic calcium phosphate, hypromellose, lactose monohydrate, magnesium sterarate, pharmaceutical ink, povidone, titanium dioxide", "Questions or comments?": "1-800-CLARITIN (1-800-252-7484) or www.claritin.com", "PRINCIPAL DISPLAY PANEL - Carton": "NDC 11523-7162-1 Non-Drowsy * Claritin-D ® pseudoephedrine sulfate 120 mg/nasal decongestant loratadine 5 mg/antihistamine Indoor & Outdoor Allergies Allergy & Congestion 12 Hour Relief of: Nasal & Sinus Congestion Due to Colds or Allergies Sneezing; Runny Nose; Itchy, Watery Eyes; Itchy Throat or Nose Due to Allergies * When taken as directed. See Drug Facts Panel. 10 EXTENDED RELEASE TABLETS"}

Drug Facts

Composition & Product

Identifiers & Packaging

Medication Information

Structured Label Content

Advanced Ingredient Data

Raw Label Data

Additional Information