Drug Facts

Composition & Product

Active Ingredients

Levocetirizine (5 mg)

Inactive Ingredients

Silicon Dioxide Cellulose, Microcrystalline Magnesium Stearate Hypromellose 2910 (5 Mpa.s) Titanium Dioxide Polyethylene Glycol 400 Lactose Monohydrate

Identifiers & Packaging

Pill Appearance

Imprint: LI Shape: oval Color: white Size: 8 mm Score: 2

Marketing Status

ANDA Active Since 2019-02-01

Medication Information

Purpose

Antihistamine

Description

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

Storage

store between 20° and 25°C (68° and 77°F)
safety sealed: do not use if carton was opened or torn

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 than1 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

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

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

Inactive Ingredients

hypromellose, lactose monohydrate, magnesium stearate, microcrystalline cellulose, polyethylene glycol 400, silicon dioxide, and titanium dioxide

Questions Or Comments?

call 1-855-839-8195

Principal Display Panel

MICRO LABS LIMITED

Container

NDC- 42571-312-90

Levocetirizine dihydrochloride Tablets USP

5mg

Antihistamine

90 Tablets MICRO LABS

Container-Carton

NDC- 42571-312-90

Levocetirizine dihydrochloride Tablets USP

5mg

Antihistamine

90 Tablets MICRO LABS

INVATECH PHARMA SOLUTIONS LLC

Container

NDC- 42571-312-90

Levocetirizine dihydrochloride Tablets USP

5mg

Antihistamine

90 Tablets MICRO LABS

Container-Carton

NDC- 42571-312-90

Levocetirizine dihydrochloride Tablets USP

5mg

Antihistamine

90 Tablets MICRO LABS

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).

Active Ingredient (in Each Tablet)

Levocetirizine dihydrochloride USP 5 mg

Ask A Doctor Before Use If You Have

ever had trouble urinating or emptying your bladder

Structured Label Content

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

Storage (STORAGE)

store between 20° and 25°C (68° and 77°F)
safety sealed: do not use if carton was opened or torn

Directions (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 than1 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

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

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

Inactive Ingredients (Inactive ingredients)

hypromellose, lactose monohydrate, magnesium stearate, microcrystalline cellulose, polyethylene glycol 400, silicon dioxide, and titanium dioxide

Questions Or Comments? (Questions or comments?)

call 1-855-839-8195

Principal Display Panel (PRINCIPAL DISPLAY PANEL)

MICRO LABS LIMITED

Container

NDC- 42571-312-90

Levocetirizine dihydrochloride Tablets USP

5mg

Antihistamine

90 Tablets MICRO LABS

Container-Carton

NDC- 42571-312-90

Levocetirizine dihydrochloride Tablets USP

5mg

Antihistamine

90 Tablets MICRO LABS

INVATECH PHARMA SOLUTIONS LLC

Container

NDC- 42571-312-90

Levocetirizine dihydrochloride Tablets USP

5mg

Antihistamine

90 Tablets MICRO LABS

Container-Carton

NDC- 42571-312-90

Levocetirizine dihydrochloride Tablets USP

5mg

Antihistamine

90 Tablets MICRO LABS

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 A Doctor If (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 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).

Active Ingredient (in Each Tablet) (Active ingredient (in each tablet))

Levocetirizine dihydrochloride USP 5 mg

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

ever had trouble urinating or emptying your bladder

Advanced Ingredient Data

[{"name": "SILICON DIOXIDE", "unii": "ETJ7Z6XBU4", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "CELLULOSE, MICROCRYSTALLINE", "unii": "OP1R32D61U", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "MAGNESIUM STEARATE", "unii": "70097M6I30", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "HYPROMELLOSE 2910 (5 MPA.S)", "unii": "R75537T0T4", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "TITANIUM DIOXIDE", "unii": "15FIX9V2JP", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "POLYETHYLENE GLYCOL 400", "unii": "B697894SGQ", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "LACTOSE MONOHYDRATE", "unii": "EWQ57Q8I5X", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "LEVOCETIRIZINE", "unii": "6U5EA9RT2O", "classCode": "ACTIB", "strengthNumerator": "5", "strengthDenominator": "1", "strengthNumeratorUnit": "mg", "strengthDenominatorUnit": "1"}]

Raw Label Data

All Sections (JSON)

{"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", "STORAGE": "store between 20° and 25°C (68° and 77°F) safety sealed: do not use if carton was opened or torn", "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 than1 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", "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", "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", "Inactive ingredients": "hypromellose, lactose monohydrate, magnesium stearate, microcrystalline cellulose, polyethylene glycol 400, silicon dioxide, and titanium dioxide", "Questions or comments?": "call 1-855-839-8195", "PRINCIPAL DISPLAY PANEL": "MICRO LABS LIMITED Container NDC- 42571-312-90 Levocetirizine dihydrochloride Tablets USP 5mg Antihistamine 90 Tablets MICRO LABS Container-Carton NDC- 42571-312-90 Levocetirizine dihydrochloride Tablets USP 5mg Antihistamine 90 Tablets MICRO LABS INVATECH PHARMA SOLUTIONS LLC Container NDC- 42571-312-90 Levocetirizine dihydrochloride Tablets USP 5mg Antihistamine 90 Tablets MICRO LABS Container-Carton NDC- 42571-312-90 Levocetirizine dihydrochloride Tablets USP 5mg Antihistamine 90 Tablets MICRO LABS", "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).", "Active ingredient (in each tablet)": "Levocetirizine dihydrochloride USP 5 mg", "Ask a doctor before use if you have": "ever had trouble urinating or emptying your bladder"}

Drug Facts

Drug Facts

Composition & Product

Identifiers & Packaging

Medication Information

Structured Label Content

Advanced Ingredient Data

Raw Label Data

Additional Information