LORATADINE AND PSEUDOEPHEDRINE SULFATE- loratadine and pseudoephedrine sulfate tablet, film coated, extended release 
Chain Drug Consortium, LLC

----------

Loratadine and Pseudoephedrine Sulfate

Drug Facts

Active ingredients (in each tablet)Purpose
Loratadine, USP 10 mgAntihistamine
Pseudoephedrine sulfate, USP 240 mgNasal 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 condtions, 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

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

  • 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

Distributed By:
Pharmacy Value Alliance, LLC
407 East Lancaster Avenue,
Wayne, PA 19087

PRINCIPAL DISPLAY PANEL - 10 Tablet Blister Pack Carton

COMPARE TO THE ACTIVE
INGREDIENTS OF CLARITIN-D® 24 HOUR

Original Prescription Strength
NON-DROWSY*

Premier
Value®

24 Hour Allergy Relief

Loratadine, USP 10 mg/Antihistamine
Pseudoephedrine Sulfate, USP 240 mg/Nasal Decongestant

ALLERGY RELIEF and
NASAL DECONGESTANT

Indoor & Outdoor Allergies

Relief of:

Nasal & Sinus Congestion Due to Colds or Allergies
Sneezing; Runny Nose; Itchy, Watery Eyes;
Itchy Throat or Nose Due to Allergies

10
Allergy & Congestion
Extended-Release Tablets

INDEPENDENTLY TESTED
SATISFACTION GUARANTEED

*When taken as directed. See Drug Facts Panel.

PRINCIPAL DISPLAY PANEL - 10 Tablet Blister Pack Carton
LORATADINE AND PSEUDOEPHEDRINE SULFATE 
loratadine and pseudoephedrine sulfate tablet, film coated, extended release
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:68016-724
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
CALCIUM CARBONATE (UNII: H0G9379FGK)  
HYPROMELLOSE, UNSPECIFIED (UNII: 3NXW29V3WO)  
FERROSOFERRIC OXIDE (UNII: XM0M87F357)  
LACTOSE MONOHYDRATE (UNII: EWQ57Q8I5X)  
MAGNESIUM STEARATE (UNII: 70097M6I30)  
MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U)  
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
SHELLAC (UNII: 46N107B71O)  
SODIUM ALGINATE (UNII: C269C4G2ZQ)  
SODIUM CITRATE, UNSPECIFIED FORM (UNII: 1Q73Q2JULR)  
TALC (UNII: 7SEV7J4R1U)  
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A)  
STARCH, CORN (UNII: O8232NY3SJ)  
POVIDONE, UNSPECIFIED (UNII: FZ989GH94E)  
HYDROXYPROPYL CELLULOSE (1600000 WAMW) (UNII: RFW2ET671P)  
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
Product Characteristics
Colorwhite (white to off-white) Scoreno score
ShapeCAPSULESize17mm
FlavorImprint Code RX724
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:68016-724-6910 in 1 BLISTER PACK; Type 0: Not a Combination Product11/17/2004
2NDC:68016-724-1515 in 1 BLISTER PACK; Type 0: Not a Combination Product11/17/2004
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
ANDAANDA07655711/17/2004
Labeler - Chain Drug Consortium, LLC (101668460)
Registrant - Sun Pharmaceutical Industries Inc. (146974886)
Establishment
NameAddressID/FEIBusiness Operations
Ohm Laboratories Inc.051565745MANUFACTURE(68016-724)

Revised: 12/2019
Document Id: 1a444c43-b3be-4df7-835d-8c9a61888167
Set id: c5c12d36-7be6-4e3e-867f-834b80a6289f
Version: 3
Effective Time: 20191227
 
Chain Drug Consortium, LLC