LORATADINE AND PSEUDOEPHEDRINE- loratadine and pseudoephedrine tablet, extended release 
Ohm Laboratories Inc.

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Loratadine and Pseudoephedrine

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 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

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

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: Ohm Laboratories Inc.
1385 Livingston Avenue
North Brunswick, NJ 08902

PRINCIPAL DISPLAY PANEL - 240 mg/10 mg Tablet Blister Pack Carton

NDC 51660-724-01

Original Prescription Strength

*Compare to the active ingredients
of Claritin-D
® 24 Hour

Non-Drowsy**

24
HOUR
RELIEF

Allergy & Congestion
Relief-D

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

Indoor & Outdoor Allergies

Relief of:
• Nasal and sinus congestion due to colds or allergies
• Sneezing • Runny nose • Itchy, watery eyes
• Itchy throat or nose due to allergies

10 Extended-Release Tablets

**When taken as directed. See Drug Facts Panel.

Actual Size

PRINCIPAL DISPLAY PANEL - 240 mg/10 mg Tablet Blister Pack Carton
LORATADINE AND PSEUDOEPHEDRINE 
loratadine and pseudoephedrine tablet, extended release
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:51660-488
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 (1200000 MW) (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
ColorwhiteScoreno score
ShapeCAPSULESize17mm
FlavorImprint Code RX724
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:51660-488-6910 in 1 BLISTER PACK; Type 0: Not a Combination Product11/17/2004
2NDC:51660-488-1515 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 - Ohm Laboratories Inc. (184769029)
Registrant - Ohm Laboratories Inc. (184769029)
Establishment
NameAddressID/FEIBusiness Operations
Ohm Laboratories Inc.184769029manufacture(51660-488)

Revised: 6/2018
Document Id: 966d0215-e71c-4150-a98d-37fb818e4387
Set id: cf256ea3-2641-4f80-abe7-fdb4ca41d710
Version: 2
Effective Time: 20180622
 
Ohm Laboratories Inc.