Claritin-D description, usages, side effects, indications, overdosage, supplying and lots more!

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Claritin-D

MSD Consumer Care, Inc.

  • Description
  • Clinical Pharmacology
  • Indications & Usage
  • Contraindications
  • Warnings
  • Precautions
  • Side Effects
  • Overdosage
  • Dosage & Administration
  • How Supplied
  • Patient Counseling Information
  • Supplemental Patient Material
  • Boxed Warning
  • Patient Package Insert

Claritin-D 24 Hour


FULL PRESCRIBING INFORMATION: CONTENTS*




FULL PRESCRIBING INFORMATION

Drug Facts

Active ingredient

Purpose

Active ingredient (in each tablet) Purpose
Loratadine 10 mg Antihistamine
Pseudoephedrine sulfate 240 mg Nasal decongestant

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

Warnings

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.

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.

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

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.

Directions

  • do not divide, crush, chew or dissolve the tablet
adults and children 12 years and over 1 tablet daily with a full glass of water; not more than 1 tablet 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 25 mg
  • safety sealed: do not use if the individual blister unit imprinted with Claritin-D® 24 hour is open or torn
  • store between 20° to 25°C (68° to 77°F)
  • protect from light and store in a dry place

Inactive ingredients

carnauba wax, dibasic calcium phosphate dihydrate, ethylcellulose, hydroxypropyl cellulose, hypromellose, magnesium stearate, pharmaceutical ink, polyethylene glycol, povidone, silicon dioxide, sucrose, titanium dioxide

Questions or comments?

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

Distributed by MSD Consumer Care, Inc., PO Box 377,
Memphis, TN 38151 USA, a subsidiary of Merck & Co., Inc.,
Whitehouse Station, NJ USA.

PRINCIPAL DISPLAY PANEL - 5 Tablet Blister Pack Carton

NDC 11523-4332-1

Non-Drowsy*
Claritin-D
®
pseudoephedrine sulfate 240 mg/nasal decongestant
loratadine 10 mg/antihistamine

Indoor & Outdoor Allergies
Allergy & Congestion

24
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.

5
EXTENDED
RELEASE TABLETS

PRINCIPAL DISPLAY PANEL - 5 Tablet Blister Pack Carton

Claritin-D

Loratadine and pseudoephedrine sulfate TABLET, EXTENDED RELEASE

Product Information

Product Type Human otc drug label Item Code (Source) NDC:11523-4332
Route of Administration ORAL DEA Schedule

Active Ingredient/Active Moiety

Ingredient Name Basis of Strength Strength
LORATADINE loratadine 10 mg
PSEUDOEPHEDRINE SULFATE PSEUDOEPHEDRINE 240 mg

Inactive Ingredients

Ingredient Name Strength
carnauba wax
CALCIUM PHOSPHATE, DIBASIC, DIHYDRATE
HYPROMELLOSES
ETHYLCELLULOSES
HYDROXYPROPYL CELLULOSE (TYPE H)
MAGNESIUM STEARATE
POLYETHYLENE GLYCOLS
POVIDONES
SILICON DIOXIDE
SUCROSE
titanium dioxide

Product Characteristics

Color Size Imprint Code Shape
WHITE (white to off-white) 18 mm Claritin;D;24 ROUND

Packaging

# Item Code Package Description Marketing Start Date Marketing End Date
1 5 in 1 BLISTER PACK
2 10 in 1 BLISTER PACK
3 5 in 1 BLISTER PACK
4 NDC:11523-4332-3 3 in 1 CARTON

Marketing Information

Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
NDA NDA020470 2009-12-01


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Be sure to consult your doctor before taking any medication!
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