Dolgencorp, Llc Allergy Relief Drug Facts

Drug Facts

Composition & Product

Active Ingredients

Levocetirizine (5 mg)

Inactive Ingredients

Hypromellose, Unspecified Lactose Monohydrate Magnesium Stearate Microcrystalline Cellulose Polyethylene Glycol, Unspecified Titanium Dioxide

Identifiers & Packaging

Pill Appearance

Imprint: L9CZ;5 Shape: oval Color: white Size: 8 mm Score: 2

Marketing Status

ANDA Active Since 2021-06-17

Medication Information

Purpose

Antihistamine

Description

Levocetirizine dihydrochloride 5 mg

Uses

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

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

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

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

Other Information

•
store between 20° and 25°C (68° and 77°F)
•
do not use if blister unit is broken or torn

Inactive Ingredients

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

Questions Or Comments?

1-888-309-9030

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 5 mg

Ask A Doctor Before Use If You Have

•
ever had trouble urinating or emptying your bladder

Package/label Principal Display Panel

Compare to the active ingredient of XYZAL® Allergy 24HR

Original Prescription Strength

Allergy Relief

Levocetirizine Dihydrochloride Tablets, 5 mg

Antihistamine

24 Hour Relief of:

- Sneezing

- Runny Nose

- Itchy Nose or Throat

- Itchy, Watery Eyes

24 HOUR

5 mg

10 Tablets

Actual Tablet Size

Structured Label Content

Uses

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

•
runny nose
•
itchy, watery eyes
•
sneezing
•
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 • 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

Other Information (Other information)

•
store between 20° and 25°C (68° and 77°F)
•
do not use if blister unit is broken or torn

Inactive Ingredients (Inactive ingredients)

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

Questions Or Comments? (Questions or comments?)

1-888-309-9030

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 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

Package/label Principal Display Panel (Package/Label Principal Display Panel)

Compare to the active ingredient of XYZAL® Allergy 24HR

Original Prescription Strength

Allergy Relief

Levocetirizine Dihydrochloride Tablets, 5 mg

Antihistamine

24 Hour Relief of:

- Sneezing

- Runny Nose

- Itchy Nose or Throat

- Itchy, Watery Eyes

24 HOUR

5 mg

10 Tablets

Actual Tablet Size

Advanced Ingredient Data

[{"name": "LEVOCETIRIZINE", "unii": "6U5EA9RT2O", "classCode": "ACTIB", "strengthNumerator": "5", "strengthDenominator": "1", "strengthNumeratorUnit": "mg", "strengthDenominatorUnit": "1"}, {"name": "HYPROMELLOSE, UNSPECIFIED", "unii": "3NXW29V3WO", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "LACTOSE MONOHYDRATE", "unii": "EWQ57Q8I5X", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "MAGNESIUM STEARATE", "unii": "70097M6I30", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "MICROCRYSTALLINE CELLULOSE", "unii": "OP1R32D61U", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "POLYETHYLENE GLYCOL, UNSPECIFIED", "unii": "3WJQ0SDW1A", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "TITANIUM DIOXIDE", "unii": "15FIX9V2JP", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}]

Raw Label Data

All Sections (JSON)

{"Uses": "temporarily relieves these symptoms due to hay fever or other respiratory allergies: • runny nose • itchy, watery eyes • sneezing • 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 • 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", "Other information": "• store between 20° and 25°C (68° and 77°F) • do not use if blister unit is broken or torn", "Inactive ingredients": "hypromellose, lactose monohydrate, magnesium stearate, microcrystalline cellulose, polyethylene glycol, titanium dioxide", "Questions or comments?": "1-888-309-9030", "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 5 mg", "Ask a doctor before use if you have": "• ever had trouble urinating or emptying your bladder", "Package/Label Principal Display Panel": "Compare to the active ingredient of XYZAL® Allergy 24HR Original Prescription Strength Allergy Relief Levocetirizine Dihydrochloride Tablets, 5 mg Antihistamine 24 Hour Relief of: - Sneezing - Runny Nose - Itchy Nose or Throat - Itchy, Watery Eyes 24 HOUR 5 mg 10 Tablets Actual Tablet Size"}

Dolgencorp, Llc Allergy Relief Drug Facts

Drug Facts

Composition & Product

Identifiers & Packaging

Medication Information

Structured Label Content

Advanced Ingredient Data

Raw Label Data

Additional Information