LORATADINE AND PSEUDOEPHEDRINE SULFATE- loratadine and pseudoephedrine sulfate tablet, film coated, extended release 
Strategic Sourcing Services LLC

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Drug Facts

ACTIVE INGREDIENTS (IN EACH TABLET)

Loratadine, USP 10 mg

Pseudoephedrine sulfate, USP 240 mg

PURPOSE

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 (1-800-222-1222).

DIRECTIONS

OTHER INFORMATION

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

Keep the carton. It contains important information.

See end panel for expiration date.

Distributed by McKesson

One Post Street, San Francisco, CA 94104

www.healthmart.com/healthmartbrand

PRINCIPAL DISPLAY PANEL - 10 Tablet Blister Pack Carton

NDC 62011-0071-1

Health Mart®

Compare to Claritin-D® 24 Hour
active ingredients

ORIGINAL PRESCRIPTION STRENGTH • NON-DROWSY*

Allergy Relief &
Nasal Decongestant

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

Indoor & Outdoor Allergies

24 Hour Relief Of: Nasal & Sinus Congestion Due to Colds
or Allergies Sneezing/Runny Nose/Itchy, Watery Eyes/
Itchy Throat or Nose Due to Allergies

ACTUAL SIZE

10 Extended-Release Tablets

*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:62011-0071
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)  
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
HYDROXYPROPYL CELLULOSE (1600000 WAMW) (UNII: RFW2ET671P)  
HYPROMELLOSE, UNSPECIFIED (UNII: 3NXW29V3WO)  
FERROSOFERRIC OXIDE (UNII: XM0M87F357)  
LACTOSE MONOHYDRATE (UNII: EWQ57Q8I5X)  
MAGNESIUM STEARATE (UNII: 70097M6I30)  
MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U)  
POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A)  
POVIDONE, UNSPECIFIED (UNII: FZ989GH94E)  
STARCH, CORN (UNII: O8232NY3SJ)  
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
SHELLAC (UNII: 46N107B71O)  
SODIUM ALGINATE (UNII: C269C4G2ZQ)  
SODIUM CITRATE, UNSPECIFIED FORM (UNII: 1Q73Q2JULR)  
TALC (UNII: 7SEV7J4R1U)  
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
Product Characteristics
Colorwhite (White to Off-White) Scoreno score
ShapeROUND (flat faced beveled edge) Size10mm
FlavorSTRAWBERRY, TUTTI FRUTTI, MINTImprint Code RC17
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:62011-0071-110 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 - Strategic Sourcing Services LLC (116956644)
Registrant - Sun Pharmaceutical Industries Inc. (146974886)
Establishment
NameAddressID/FEIBusiness Operations
Ohm Laboratories Inc.051565745manufacture(62011-0071)

Revised: 12/2019
Document Id: b564f03b-b9de-41ae-9cd2-67cd193bc937
Set id: 48bfc938-d97d-4b49-8637-3b00ac870902
Version: 4
Effective Time: 20191230
 
Strategic Sourcing Services LLC