Your browser does not support JavaScript! LORATADINE AND PSEUDOEPHEDRINE SULFATE TABLET, FILM COATED, EXTENDED RELEASE [SELECT BRAND]
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LORATADINE AND PSEUDOEPHEDRINE SULFATE tablet, film coated, extended release
[Select Brand]


Category DEA Schedule Marketing Status
HUMAN OTC DRUG LABEL Abbreviated New Drug Application
Drug Label Sections

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 over1 tablet daily with a full glass of water; not more than 1 tablet in 24 hours
    children under 12 years of ageask a doctor
    consumers with liver or kidney diseaseask 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

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

NDC 15127-717-05

NON-DROWSY*

select brand®

Original Prescription Strength

Allergy Relief and Nasal Decongestant

24 Hour Formula

Loratadine, USP 10 mg/Antihistamine

Pseudoephedrine Sulfate, USP 240 mg/Nasal Decongestant

Indoor & Outdoor Allergies

Allergy & Congestion

RELIEF OF:

Nasal and Sinus Congestion Due to Colds or Allergies

Sneezing; Runny Nose

Itchy, Watery Eyes; Itchy Throat

or Nose Due to Allergies

5 Extended-Release Tablets

*When taken as directed. See Drug Facts Panel.

Distributed by: SELECT BRAND DISTRIBUTORS

5079457/R0710

This is the 5 count blister carton label for Select Brand Loratadine D tablets.
LORATADINE AND PSEUDOEPHEDRINE SULFATE 
loratadine and pseudoephedrine sulfate tablet, film coated, extended release
Product Information
Product TypeHUMAN OTC DRUG LABELItem Code (Source)NDC:15127-717
Route of AdministrationORALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
LORATADINE (LORATADINE) LORATADINE10 mg
PSEUDOEPHEDRINE SULFATE (PSEUDOEPHEDRINE) PSEUDOEPHEDRINE SULFATE240 mg
Inactive Ingredients
Ingredient NameStrength
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
Colorwhite (White to Off-White) Scoreno score
ShapeCAPSULESize17mm
FlavorImprint Code RX724
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:15127-717-1515 in 1 BLISTER PACK
2NDC:15127-717-055 in 1 BLISTER PACK
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
ANDAANDA07655711/17/2004
Labeler - Select Brand (043562370)
Registrant - Ranbaxy Pharmaceuticals Inc. (937890044)
Establishment
NameAddressID/FEIBusiness Operations
Ohm Laboratories Inc.051565745manufacture(15127-717)

Revised: 9/2012
 
Select Brand

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