ALLERGY RELIEF-D 24 HOUR- loratadine and pseudoephedrine sulfate tablet, extended release 
Shopko Stores Operating Co., LLC.

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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

● temporarily relieves these symptoms due to hay fever or other upper respiratory allergies:

● temporarily relieves nasal congestion due to the common cold, hay fever or other upper respiratory allergies

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? 1-800-432-8534 between 9 am and 4 pm EST, Monday – Friday.

PRINCIPAL DISPLAY PANEL

PDP

Shopko®
NDC 37012-239-79
**Compare to Claritin-D® 24 Hour active ingredients
Non-Drowsy*
Allergy Relief-D
Loratadine, USP 10mg/Pseudoephedrine Sulfate, USP 240 mg
Extended- Release Tablets
Antihistamine / Nasal Decongestant
Indoor & Outdoor Allergies

Allergy & Congestion
24 Hour 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

Allergy Relief D

 

ALLERGY RELIEF-D  24 HOUR
loratadine and pseudoephedrine sulfate tablet, extended release
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:37012-239
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
Colorwhite (white to off-white) Scoreno score
ShapeOVALSize18mm
FlavorImprint Code Andrx;605
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:37012-239-792 in 1 CARTON03/01/2016
15 in 1 BLISTER PACK; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
ANDAANDA07570603/01/201605/31/2024
Labeler - Shopko Stores Operating Co., LLC. (023252638)

Revised: 11/2021
Document Id: f3372e1d-a50e-430c-8da8-1ac7fc362e45
Set id: f77606a5-08f9-4774-80ff-c90ad24c5b02
Version: 7
Effective Time: 20211101
 
Shopko Stores Operating Co., LLC.