LORATADINE AND PSEUDOEPHEDRINE SULFATE- loratadine and pseudoephedrine sulfate tablet, film coated, extended release 
Topco Associates 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 1-888-423-0139

PRINCIPAL DISPLAY PANEL

TopCare®

NDC 36800-724-69

NON-DROWSY*

24 HOUR

Original Prescription Strength

Allergy Relief - D

PSEUDOEPHEDRINE SULFATE, USP 240 mg/NASAL DECONGESTANT

LORATADINE, USP 10 mg/ANTIHISTAMINE EXTENDED RELEASE TABLETS

Indoor & Outdoor Allergies

Relief of:

Nasal and Sinus Congestion Due to Cold or Allergies

Sneezing; Runny Nose; Itchy, Watery Eyes

Itchy Throat or Nose Due to Allergies

10 EXTENDED RELEASE TABLETS

COMPARE TO CLARITIN-D®24 HOUR active ingredients

*When taken as directed. See Drug Facts Panel.

DIST.BY TOPCO ASSOCIATES LLC

5095191/R0412

This is the 10 count blister carton label for TopCare Loratadine D tablets.

LORATADINE AND PSEUDOEPHEDRINE SULFATE 
loratadine and pseudoephedrine sulfate tablet, film coated, extended release
Product Information
Product Type HUMAN OTC DRUG Item Code (Source) NDC:36800-724
Route of Administration ORAL DEA Schedule     
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
CALCIUM CARBONATE (UNII: H0G9379FGK)  
COLLOIDAL SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
HYDROXYPROPYL CELLULOSE (UNII: RFW2ET671P)  
HYPROMELLOSES (UNII: 3NXW29V3WO)  
FERROSOFERRIC OXIDE (UNII: XM0M87F357)  
LACTOSE MONOHYDRATE (UNII: EWQ57Q8I5X)  
MAGNESIUM STEARATE (UNII: 70097M6I30)  
CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)  
POLYETHYLENE GLYCOLS (UNII: 3WJQ0SDW1A)  
POVIDONE (UNII: FZ989GH94E)  
STARCH, PREGELATINIZED CORN (UNII: O8232NY3SJ)  
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
SHELLAC (UNII: 46N107B71O)  
SODIUM ALGINATE (UNII: C269C4G2ZQ)  
SODIUM CITRATE (UNII: 1Q73Q2JULR)  
TALC (UNII: 7SEV7J4R1U)  
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
Product Characteristics
Color white (White to Off-white) Score no score
Shape CAPSULE Size 17mm
Flavor Imprint Code RX724
Contains     
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1 NDC:36800-724-69 10 in 1 BLISTER PACK
2 NDC:36800-724-15 15 in 1 BLISTER PACK
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA076557 11/17/2004
Labeler - Topco Associates LLC (006935977)
Registrant - Ranbaxy Pharmaceuticals Inc. (937890044)
Establishment
Name Address ID/FEI Business Operations
Ohm Laboratories Inc. 051565745 manufacture(36800-724)

Revised: 12/2012
Document Id: 71a4c639-174f-4480-91c1-033eb90b85f7
Set id: d2b77078-5124-443e-a6db-5860170f7a13
Version: 1
Effective Time: 20121218
 
Topco Associates LLC