Loratadine and Pseudoephedrine Sulfate description, usages, side effects, indications, overdosage, supplying and lots more!

Loratadine and Pseudoephedrine Sulfate

Chain Drug Marketing Association Inc.
Ranbaxy Pharmaceuticals 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
Drug Facts

FULL PRESCRIBING INFORMATION: CONTENTS*




FULL PRESCRIBING INFORMATION

ACTIVE INGREDIENTS (IN EACH TABLET)

Loratadine, USP 10 mg

Pseudoephedrine sulfate, USP 240 mg

PURPOSE

Antihistamine

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
  • reduces swelling of nasal passages
  • temporarily relieves sinus congestion and pressure
  • temporarily relieves nasal congestion due to the common cold, hay fever or other upper respiratory allergies
  • 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 (1-800-222-1222).

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

  • sodium: contains 10 mg/tablet
  • calcium: contains 25 mg/tablet
  • TAMPER EVIDENT: DO NOT USE IF BLISTER UNITS ARE TORN, BROKEN OR SHOW ANY SIGNS OF TAMPERING.
  • store between 20° C to 25° C (68° F to 77° F).
  • protect from light and store in a dry place

INACTIVE INGREDIENTS

Calcium carbonate, colloidal silicon dioxide, hydroxypropyl cellulose, hypromellose, iron oxide black, lactose monohydrate, magnesium stearate, microcrystalline cellulose, polyethylene glycol, povidone, pregelatinized starch, propylene glycol, shellac glaze, sodium alginate, sodium citrate, talc and titanium dioxide

QUESTIONS?

Call 1-800-406-7984

PRINCIPAL DISPLAY PANEL

QC QUALITY CHOICE ®

NDC 63868-0154-10

Compare to the active ingredients in Claritin-D ® 24 Hour

Non-Drowsy *

Original Prescription Strength

24 Hour Formula

Allergy Relief and Nasal Decongestant

Loratadine-D

Loratadine, USP 10 mg/Antihistamine

Pseudoephedrine Sulfate, USP 240 mg/Nasal Decongestant

Allergy and Congestion

Indoor & Outdoor Allergies

Relief of:

Nasal and Sinus Congestion Due to Colds or Allergies

Sneezing; Runny Nose; Itchy, Watery Eyes;

Itchy Throat or Nose Due to Allergies

10 Extended-Release Tablets

* When taken as directed. See Drug Facts Panel.

© DISTRIBUTED BY QUALITY CHOICE

5079450 R0710

Loratadine and Pseudoephedrine Sulfate

Loratadine and Pseudoephedrine Sulfate TABLET, FILM COATED, EXTENDED RELEASE

Product Information

Product Type Human otc drug label Item Code (Source) NDC:63868-154
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
CALCIUM CARBONATE
COLLOIDAL SILICON DIOXIDE
hydroxypropyl cellulose
HYPROMELLOSES
FERROSOFERRIC OXIDE
lactose monohydrate
MAGNESIUM STEARATE
cellulose, microcrystalline
POLYETHYLENE GLYCOLS
povidone
STARCH, PREGELATINIZED CORN
propylene glycol
SHELLAC
SODIUM ALGINATE
SODIUM CITRATE
talc
titanium dioxide

Product Characteristics

Color Size Imprint Code Shape
white (White to Off-White) 17 mm RX724 CAPSULE

Packaging

# Item Code Package Description Marketing Start Date Marketing End Date
1 NDC:63868-154-10 10 in 1 BLISTER PACK

Marketing Information

Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA076557 2004-11-17


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