ALLERGY RELIEF 24HR- levocetirizine dihydrochloride tablet 
Vitesse Pharma LLC

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Allergy Relief 24HR

Allergy Relief 24HR Tablet

Drug Facts

Active ingredient

(in each tablet)

Levocetirizine dihydrochloride 5 mg

Purpose

Antihistamine

Uses

temporarily relieves these symptoms due to hay fever or other respiratory allergies:

Warnings

Do not use

  • if you have kidney disease
  • if you have ever had an allergic reaction to this product or any of its ingredients or to an antihistamine containing cetirizine

Ask a doctor before use if you have

  • ever had trouble urinating or emptying your bladder

When using this product

  • drowsiness may occur
  • avoid alcoholic drinks
  • alcohol, sedatives, and tranquilizers may increase drowsiness
  • be careful when driving a motor vehicle or operating machinery

Stop use and ask a doctor if

  • you have trouble urinating or emptying your bladder
  • an allergic reaction to this product occurs. Seek medical help right away.

If pregnant or breast-feeding:

  • if breast-feeding: not recommended
  • if pregnant: 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 65 years of age and older■ ask a doctor
adults and children 12-64 years of age ■ take 1 tablet (5 mg) once daily in the evening
■ do not take more than 1 tablet (5 mg) in 24 hours
■ ½ tablet (2.5 mg) once daily in the evening may be appropriate for less severe symptoms
children 6-11 years of age■ take ½ tablet (2.5 mg) once daily in the evening
■ do not take more than ½ tablet (2.5 mg) in 24 hours
children under 6 years of age■ do not use
consumers with kidney disease■ do not use

(Note: Age ranges are bolded in the draft container labeling for tablet bottle)

Other information

Inactive ingredients

colloidal anhydrous silica, hypromellose, lactose monohydrate, magnesium stearate, microcrystalline cellulose, polyethylene glycol 400, titanium dioxide

Questions or comments?

call 1-855-314-1850

PRINCIPAL DISPLAY PANEL

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ALLERGY RELIEF 24HR 
levocetirizine dihydrochloride tablet
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:73226-001
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
LEVOCETIRIZINE DIHYDROCHLORIDE (UNII: SOD6A38AGA) (LEVOCETIRIZINE - UNII:6U5EA9RT2O) LEVOCETIRIZINE DIHYDROCHLORIDE5 mg
Inactive Ingredients
Ingredient NameStrength
HYPROMELLOSES (UNII: 3NXW29V3WO)  
LACTOSE MONOHYDRATE (UNII: EWQ57Q8I5X)  
MAGNESIUM STEARATE (UNII: 70097M6I30)  
MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U)  
POLYETHYLENE GLYCOL 400 (UNII: B697894SGQ)  
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
Product Characteristics
ColorwhiteScore2 pieces
ShapeOVALSize8mm
FlavorImprint Code X;X
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:73226-001-0040 in 1 CARTON07/02/2019
12500 in 1 BAG; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
ANDAANDA21155107/02/2019
Labeler - Vitesse Pharma LLC (102376674)

Revised: 1/2021
Document Id: b8a3181d-990f-454f-e053-2995a90a96c0
Set id: 64077f58-3e20-4af0-89b8-ca50f43a32f6
Version: 3
Effective Time: 20210111
 
Vitesse Pharma LLC