ALLERGY RELIEF-D 24 HOUR 24 HOUR- loratadine and pseudoephedrine sulfate tablet, extended release 
Actavis Pharma, Inc.

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Loratadine and Pseudoephedrine Sulfate Extended-Release Tablets

Drug Facts

Active ingredients (in each tablet)

Loratadine, USP 10 mg
Pseudoephedrine sulfate, USP 240 mg

Purposes

Antihistamine
Nasal decongestant

Uses

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

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

Inactive ingredients

black iron oxide, candelilla wax powder, colloidal silicon dioxide, glyceryl monostearate, hypromellose, lactose monohydrate, magnesium stearate, polyethylene glycol, polysorbate 80, propylene glycol, sodium lauryl sulfate, talc and titanium dioxide

Questions?

1-888-838-2872 between 9 am and 5 pm ET, Monday – Friday.

Principal Display Panel

Actavis

NDC 52544-239-12
Compare to the active ingredients 
in Claritin-D® 24 Hour

Non-Drowsy*
Allergy Relief-D
Loratadine, USP 10 mg/Pseudoephedrine Sulfate, USP 240 mg
Extended-Release Tablets
Antihistamine/Nasal Decongestant

24 Hour Relief of:

*When taken as directed. See Drug Facts Panel.

Indoor & Outdoor Allergies
Allergy & Congestion
15 Extended-Release Tablets

image

ALLERGY RELIEF-D 24 HOUR  24 HOUR
loratadine and pseudoephedrine sulfate tablet, extended release
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:52544-239
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
LORATADINE (UNII: 7AJO3BO7QN) (LORATADINE - UNII:7AJO3BO7QN) LORATADINE10 mg
PSEUDOEPHEDRINE SULFATE (UNII: Y9DL7QPE6B) (PSEUDOEPHEDRINE - UNII:7CUC9DDI9F) PSEUDOEPHEDRINE SULFATE240 mg
Inactive Ingredients
Ingredient NameStrength
FERROSOFERRIC OXIDE (UNII: XM0M87F357)  
CANDELILLA WAX (UNII: WL0328HX19)  
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)  
HYPROMELLOSE, UNSPECIFIED (UNII: 3NXW29V3WO)  
HYPROMELLOSE 2910 (3 MPA.S) (UNII: 0VUT3PMY82)  
HYPROMELLOSE 2910 (6 MPA.S) (UNII: 0WZ8WG20P6)  
LACTOSE MONOHYDRATE (UNII: EWQ57Q8I5X)  
MAGNESIUM STEARATE (UNII: 70097M6I30)  
POLYETHYLENE GLYCOL 400 (UNII: B697894SGQ)  
POLYETHYLENE GLYCOL 8000 (UNII: Q662QK8M3B)  
POLYSORBATE 80 (UNII: 6OZP39ZG8H)  
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
SODIUM LAURYL SULFATE (UNII: 368GB5141J)  
TALC (UNII: 7SEV7J4R1U)  
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
Product Characteristics
ColorWHITEScoreno score
ShapeOVALSize18mm
FlavorImprint Code Andrx;605
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:52544-239-123 in 1 CARTON06/14/2018
15 in 1 BLISTER PACK; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
ANDAANDA07570606/14/2018
Labeler - Actavis Pharma, Inc. (119723554)

Revised: 11/2019
Document Id: 8d2dbc48-3d5e-453f-bf64-ffbfd35c6962
Set id: e259bb5d-7845-4823-acee-da93357bf230
Version: 2
Effective Time: 20191112
 
Actavis Pharma, Inc.