HEALTHY ACCENTS ALLERGY AND CONGESTION RELIEF 24 HOUR NON DROWSY- loratadine, pseudoephedrine sulfate tablet, extended release 
DZA Brands LLC

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DZA Brands, LLC Allergy & Congestion Relief Drug Facts

Active ingredient (in each tablet)

Loratadine 10 mg

Pseudoephedrine sulfate 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
temporarily relieves nasal congestion due to the common cold, hay fever, or other upper respiratory allergies
reduces swelling of nasal passages
temporarily relieves sinus congestion and pressure
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.

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

do not use if blister unit is broken or torn
store between 20ºC to 25ºC (68ºF to 77ºF)
protect from light and store in a dry place

Inactive ingredients

black iron oxide, candelilla wax powder, colloidal silicon dioxide, glyceryl monostearate, hypromellose, lactose monohydrate, magnesium stearate, polyethylene glycol, polysorbate 80, propylene glycol, sodium lauryl sulfate, talc, titanium dioxide

Questions or comments?

1-866-322-2439

Principal Display Panel

Compare to Claritin-D® 24 Hour active ingredients

24 Hour

Non-Drowsy

Allergy & congestion relief

Pseudoephedrine Sulfate 240mg - nasal decongestant

Loratadine 10mg - antihistamine

Extended release tablets

24 Hour relief of:

Nasal and sinus congestion due to colds or allergies

Sneezing

Runny nose

Itchy, watery eyes

Itchy throat or nose due to allergies

Actual Size

*When Taken As Directed. See Drug Facts Panel.

Allergy & Congestion Relief Carton Image 1

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HEALTHY ACCENTS ALLERGY AND CONGESTION RELIEF  24 HOUR NON DROWSY
loratadine, pseudoephedrine sulfate tablet, extended release
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:55316-165
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
PSEUDOEPHEDRINE SULFATE (UNII: Y9DL7QPE6B) (PSEUDOEPHEDRINE - UNII:7CUC9DDI9F) PSEUDOEPHEDRINE SULFATE240 mg
LORATADINE (UNII: 7AJO3BO7QN) (LORATADINE - UNII:7AJO3BO7QN) LORATADINE10 mg
Inactive Ingredients
Ingredient NameStrength
FERROSOFERRIC OXIDE (UNII: XM0M87F357)  
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)  
HYPROMELLOSES (UNII: 3NXW29V3WO)  
LACTOSE MONOHYDRATE (UNII: EWQ57Q8I5X)  
MAGNESIUM STEARATE (UNII: 70097M6I30)  
POLYETHYLENE GLYCOLS (UNII: 3WJQ0SDW1A)  
POLYSORBATE 80 (UNII: 6OZP39ZG8H)  
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
SODIUM LAURYL SULFATE (UNII: 368GB5141J)  
TALC (UNII: 7SEV7J4R1U)  
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
CANDELILLA WAX (UNII: WL0328HX19)  
Product Characteristics
ColorWHITE (to off white) Scoreno score
ShapeOVALSize18mm
FlavorImprint Code Andrx;605
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:55316-165-522 in 1 CARTON06/23/201102/04/2017
15 in 1 BLISTER PACK; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
ANDAANDA07570606/23/201102/04/2017
Labeler - DZA Brands LLC (090322194)

Revised: 11/2017
 
DZA Brands LLC