levocetirizine dihydrochloride tablets usp, 5 mg

levocetirizine dihydrochloride tablets usp, 5 mg
SPL v4
SPL
SPL Set ID bb8d38b2-117a-fc6b-4ba0-0bc0188cbcd1
Route
oral
Published
Effective Date 2018-01-23
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
levocetirizine (5 mg)
Inactive Ingredients
cellulose, microcrystalline lactose monohydrate silicon dioxide magnesium stearate hypromelloses titanium dioxide polyethylene glycol, unspecified

Identifiers & Packaging

Marketing Status
anda active Since 2020-06-24

Purpose

Antihistamine

Description

Levocetirizine dihydrochloride USP, 5 mg


Medication Information

Warnings

Active Ingredient

Levocetirizine dihydrochloride USP, 5 mg

Uses

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

  • runny nose
  • sneezing
  • itchy, watery eyes
  • itching of the nose or throat

Purpose

Antihistamine

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
  • 1/2 tablet (2.5 mg) once daily in the evening may be appropriate for less severe symptoms
children 6-11 years of age
  • take 1/2 tablet (2.5 mg) once daily in the evening
  • do not take more than 1/2 tablet (2.5 mg) in 24 hours
children under 6 years of age
  • do not use
consumers with kidney disease
  • do not use

Other Information
  • store between 20° and 25°C (68° and 77°F)
  • safety sealed: do not use if carton was opened or if printed foil inner seal on bottle is torn or missing

Inactive Ingredients

colloidal silicon dioxide, hypromellose, lactose monohydrate, magnesium stearate, microcrystalline cellulose, polyethylene glycol, titanium dioxide

Description

Levocetirizine dihydrochloride USP, 5 mg

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
Questions Or Comments?

Call 1-888-375-3784

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 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).

Ask A Doctor Before Use If You Have

  • ever had trouble urinating or emptying your bladder
Levocetirizine Dihydrochloride Tablets, Usp 5 Mg Carton Label

Original Prescription Strength

Levocetirizine

Dihydrochloride

Tablets USP, 5 mg


Antihistamine

24 Hour Relief of:

  • Sneezing
  • Runny Nose
  • Itchy Nose or Throat
  • Itchy, Watery Eyes




Structured Label Content

Warnings

Active Ingredient (Active ingredient (in each tablet))

Levocetirizine dihydrochloride USP, 5 mg

Uses

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

  • runny nose
  • sneezing
  • itchy, watery eyes
  • itching of the nose or throat

Purpose

Antihistamine

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
  • 1/2 tablet (2.5 mg) once daily in the evening may be appropriate for less severe symptoms
children 6-11 years of age
  • take 1/2 tablet (2.5 mg) once daily in the evening
  • do not take more than 1/2 tablet (2.5 mg) in 24 hours
children under 6 years of age
  • do not use
consumers with kidney disease
  • do not use

Other Information (Other information)
  • store between 20° and 25°C (68° and 77°F)
  • safety sealed: do not use if carton was opened or if printed foil inner seal on bottle is torn or missing

Inactive Ingredients (Inactive ingredients)

colloidal silicon dioxide, hypromellose, lactose monohydrate, magnesium stearate, microcrystalline cellulose, polyethylene glycol, titanium dioxide

Do Not Use (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
Questions Or Comments? (Questions or comments?)

Call 1-888-375-3784

When Using This Product (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 Doctor If (Stop use and ask 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 pregnant or breast-feeding:)
  • if breast-feeding: not recommended
  • if pregnant: ask a health professional before use
Keep Out of Reach of Children. (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).

Ask A Doctor Before Use If You Have (Ask a doctor before use if you have)

  • ever had trouble urinating or emptying your bladder
Levocetirizine Dihydrochloride Tablets, Usp 5 Mg Carton Label (Levocetirizine Dihydrochloride Tablets, USP 5 mg carton label)

Original Prescription Strength

Levocetirizine

Dihydrochloride

Tablets USP, 5 mg


Antihistamine

24 Hour Relief of:

  • Sneezing
  • Runny Nose
  • Itchy Nose or Throat
  • Itchy, Watery Eyes




Advanced Ingredient Data


Raw Label Data

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