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

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Claritin-D

MSD Consumer Care, Inc.

Claritin-D 12 Hour


FULL PRESCRIBING INFORMATION: CONTENTS*




FULL PRESCRIBING INFORMATION

Drug Facts

Active ingredient

Purpose

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

Claritin-D 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 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

Claritin-D 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

© Copyright & 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 - Blister Pack 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

Claritin-D

Claritin-D

Loratadine and pseudoephedrine sulfate TABLET, EXTENDED RELEASE

Product Information

Product Type Human otc drug label Item Code (Source) NDC:11523-7162
Route of Administration ORAL DEA Schedule

Active Ingredient/Active Moiety

Ingredient Name Basis of Strength Strength
LORATADINE loratadine 5 mg
PSEUDOEPHEDRINE SULFATE PSEUDOEPHEDRINE 120 mg

Inactive Ingredients

Ingredient Name Strength
CROSCARMELLOSE SODIUM
CALCIUM PHOSPHATE, DIBASIC, ANHYDROUS
HYPROMELLOSES
lactose monohydrate
MAGNESIUM STEARATE
POVIDONES
titanium dioxide

Product Characteristics

Color Size Imprint Code Shape
WHITE (white to off-white) 12 mm Claritin;D;12 OVAL

Packaging

# Item Code Package Description Marketing Start Date Marketing End Date
1 10 in 1 BLISTER PACK
2 10 in 1 BLISTER PACK
3 10 in 1 BLISTER PACK
4 NDC:11523-7162-3 3 in 1 CARTON

Marketing Information

Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
NDA NDA019670 2009-12-01


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Be sure to consult your doctor before taking any medication!
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