← See all Loratadine and Pseudoephedrine Sulfate brands

Loratadine and Pseudoephedrine Sulfate

Dosage form: tablet, film coated, extended release
Ingredients: LORATADINE 10mg, PSEUDOEPHEDRINE SULFATE 240mg
Labeler: Safeway Inc.
NDC Code: 21130-724

Drug Facts

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 OR COMMENTS?

Call 1-888-SAFEWAY

PRINCIPAL DISPLAY PANEL

Original Prescription Strength

Compare to Claritin-D®24 Hour active ingredients

Non-Drowsy*

24-Hour Allergy & Congestion Relief D

Pseudoephedrine Sulfate, USP 240 mg/Nasal Decongestant

Loratadine, USP 10 mg/Antihistamine

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

*When taken as directed.

See Drug Facts Panel.

10 EXTENDED-RELEASE TABLETS

SAFEWAY

DISTRIBUTED BY SAFEWAY INC.

5079455/R0211

LORATADINE AND PSEUDOEPHEDRINE SULFATE 
loratadine and pseudoephedrine sulfate tablet, film coated, extended release
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:21130-724
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 CodeRX724
Contains    
Packaging
#Item CodePackage Description
1NDC:21130-724-6910 TABLET, FILM COATED, EXTENDED RELEASE (TABLET) in 1 BLISTER PACK
2NDC:21130-724-1515 TABLET, FILM COATED, EXTENDED RELEASE (TABLET) in 1 BLISTER PACK
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
ANDAANDA07655711/17/2004
Labeler - Safeway Inc. (009137209)
Registrant - Ranbaxy Pharmaceuticals Inc. (937890044)
Establishment
NameAddressID/FEIOperations
Ohm Laboratories Inc.051565745manufacture(21130-724)

Revised: 09/2012
 
Safeway Inc.

← See all Loratadine and Pseudoephedrine Sulfate brands

Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

Hide
(web2)