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Loratadine and Pseudoephedrine Sulfate

Medically reviewed on Oct 8, 2018

Dosage form: tablet, film coated, extended release
Ingredients: LORATADINE 10mg, PSEUDOEPHEDRINE SULFATE 240mg
Labeler: Chain Drug Consortium, LLC
NDC Code: 68016-724

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

CHAIN DRUG CONSORTIUM

3301 NW BOCA RATON BLVD

SUITE 101, BOCA RATON, FL 33431

PRINCIPAL DISPLAY PANEL

Premier Value®

NDC 68016-724-69

Original Prescription Strength

NON-DROWSY*

24 Hour Allergy Relief

Loratadine , USP 10mg/Antihistamine

Pseudoephedrine Sulfate, USP 240mg/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

COMPARE TO THE ACTIVEINGREDIENTS OF CLARITIN-D® 24 HOUR

*When taken as directed. See Drug Facts Panel.

This product is not manufactured or distributed by Schering-Plough HealthCare Products, Inc. CLARITIN-D®24 HOURis a registered trademark of Schering Corporation.

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 AdministrationORALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
LORATADINE (LORATADINE) LORATADINE10 mg
PSEUDOEPHEDRINE SULFATE (PSEUDOEPHEDRINE) PSEUDOEPHEDRINE SULFATE240 mg
Inactive Ingredients
Ingredient NameStrength
CALCIUM CARBONATE 
HYPROMELLOSES 
FERROSOFERRIC OXIDE 
LACTOSE MONOHYDRATE 
MAGNESIUM STEARATE 
CELLULOSE, MICROCRYSTALLINE 
PROPYLENE GLYCOL 
SHELLAC 
SODIUM ALGINATE 
SODIUM CITRATE 
TALC 
TITANIUM DIOXIDE 
POLYETHYLENE GLYCOLS 
STARCH, CORN 
POVIDONES 
HYDROXYPROPYL CELLULOSE (TYPE H) 
SILICON DIOXIDE 
Product Characteristics
Colorwhite (white to off-white) Scoreno score
ShapeCAPSULESize17mm
FlavorImprint CodeRX724
Contains    
Packaging
#Item CodePackage Description
1NDC:68016-724-6910 TABLET, FILM COATED, EXTENDED RELEASE in 1 BLISTER PACK
2NDC:68016-724-1515 TABLET, FILM COATED, EXTENDED RELEASE in 1 BLISTER PACK
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
ANDAANDA07655711/17/2004
Labeler - Chain Drug Consortium, LLC (101668460)
Registrant - Ranbaxy Pharmaceuticals Inc. (937890044)
Establishment
NameAddressID/FEIOperations
Ohm Laboratories Inc.051565745MANUFACTURE(68016-724)

 
Chain Drug Consortium, LLC

← See all Loratadine and Pseudoephedrine Sulfate brands

Further information

Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.

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