LORATADINE AND PSEUDOEPHEDRINE- loratadine and pseudoephedrine tablet, extended release 
AMERISOURCE BERGEN

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Drug Facts

Active ingredient

Loratadine, USP 10 mg

Pseudoephedrine sulfate, USP 240

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

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

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

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.
store between 20 ° C to 25 ° C (68 ° F to 77 ° F)
protect from light and store in a dry

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

PRINCIPAL DISPLAY PANEL - 15 Tablet Blister Pack Carton

Compare to active ingredients in
Claratin-D® 24 hour**

NDC 46122-383-22

GOOD
NEIGHBOR
PHARMACY®

Non-Drowsy*
24 HOUR

Allergy &
Congestion Relief
pseudoephedrine sulfate, USP 240 mg/nasal decongestant
loratadine, USP 10 mg/antihistamine

Indoor & Outdoor Allergies

Extended-Release Tablets

Relief of:
• Nasal and Sinus Congestion Due to Colds or Allergies
• Sneezing • Runny Nose • Itchy, Watery Eyes
• Itchy Throat or Nose Due to Allergies

15 tablets

*When taken as directed. See Drug Facts Panel.

Principal Display Panel - 15 Tablet Blister Pack Carton
LORATADINE AND PSEUDOEPHEDRINE 
loratadine and pseudoephedrine tablet, extended release
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:46122-383
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)  
TALC (UNII: 7SEV7J4R1U)  
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
SODIUM CITRATE, UNSPECIFIED FORM (UNII: 1Q73Q2JULR)  
Product Characteristics
ColorwhiteScoreno score
ShapeCAPSULESize17mm
FlavorImprint Code RX724
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:46122-383-2215 in 1 BLISTER PACK; Type 0: Not a Combination Product08/02/2017
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
ANDAANDA07655708/02/2017
Labeler - AMERISOURCE BERGEN (007914906)
Establishment
NameAddressID/FEIBusiness Operations
Ohm Laboratories Inc.184769029MANUFACTURE(46122-383)

Revised: 6/2021
Document Id: 39ace1fb-0f76-4ff6-8846-e6316ee972e5
Set id: 96635cb0-8c78-4c3a-8294-2804ff26f90a
Version: 2
Effective Time: 20210603
 
AMERISOURCE BERGEN