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 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

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 Type HUMAN OTC DRUG Item Code (Source) NDC:52544-239
Route of Administration ORAL
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
LORATADINE (UNII: 7AJO3BO7QN) (LORATADINE - UNII:7AJO3BO7QN) LORATADINE 10 mg
PSEUDOEPHEDRINE SULFATE (UNII: Y9DL7QPE6B) (PSEUDOEPHEDRINE - UNII:7CUC9DDI9F) PSEUDOEPHEDRINE SULFATE 240 mg
Inactive Ingredients
Ingredient Name Strength
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
Color WHITE Score no score
Shape OVAL Size 18mm
Flavor Imprint Code Andrx;605
Contains     
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1 NDC:52544-239-12 3 in 1 CARTON 06/14/2018
1 5 in 1 BLISTER PACK; Type 0: Not a Combination Product
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA075706 06/14/2018
Labeler - Actavis Pharma, Inc. (119723554)

Revised: 2/2018
Document Id: ec6dcd09-3f9f-49eb-9bad-dc3ecc94ffbc
Set id: e259bb5d-7845-4823-acee-da93357bf230
Version: 1
Effective Time: 20180201
 
Actavis Pharma, Inc.