LORATADINE AND PSEUDOEPHEDRINE SULFATE- loratadine and pseudoephedrine sulfate tablet, film coated, extended release 
STRATEGIC SOURCING SERVICES

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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

temporarily relieves these symptoms due to hay fever or other upper respiratory allergies:
sneezing
itchy, watery eyes
runny nose
itching of the nose or throat
reduces swelling of nasal passages
temporarily relieves sinus congestion and pressure
temporarily relieves nasal congestion due to the common cold, hay fever or other upper respiratory allergies
temporarily restores freer breathing through the nose

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

do not divide, crush, chew or dissolve the tablet

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

sodium: contains 10 mg/tablet
calcium: contains 25 mg/tablet
TAMPER EVIDENT: DO NOT USE IF BLISTER UNITS ARE TORN, BROKEN OR SHOW ANY SIGNS OF TAMPERING. (for blister cartons only)
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

Keep the carton. It contains important information.

See end panel for expiration date.

Distributed By McKesson

One Post Street, San Francisco, CA 94104

www.sunmarkbrand.com

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

sunmark®

COMPARE TO CLARITIN-D® 24 HOUR
TABLETS ACTIVE INGREDIENTS**

NDC 49348-543-57

 
24 HOUR
Original Prescription Strength

allergy & congestion

lorata•dine 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 Colds or Allergies
Sneezing; Runny Nose; Itchy, Watery Eyes;
Itchy Throat or Nose Due to Allergies

NON-DROWSY*

15 Extended-Release Tablets

*When taken
as directed.
See Drug
Facts Panel.

PRINCIPAL DISPLAY PANEL - 240 mg/10 mg 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:49348-543
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, UNSPECIFIED (UNII: 9XZ8H6N6OH)  
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
ShapeCAPSULESize17mm
FlavorImprint Code RX724
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:49348-543-0110 in 1 BLISTER PACK; Type 0: Not a Combination Product11/17/2004
2NDC:49348-543-5715 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 (116956644)
Establishment
NameAddressID/FEIBusiness Operations
Ohm Laboratories Inc.051565745MANUFACTURE(49348-543)

Revised: 7/2020
Document Id: 6459b34c-2237-4931-af7a-507effd2daf0
Set id: 114b5e7c-973a-4a34-8538-a214de090b39
Version: 3
Effective Time: 20200730
 
STRATEGIC SOURCING SERVICES