Amazon 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 2020-10-29

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 printed foil under cap is broken or missing

Inactive Ingredients

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

Questions Or Comments?

1-800-719-9260

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

Original Prescription Strength

Compare to XYZAL^® Allergy 24HR

active ingredient

Allergy Relief

Levocetirizine Dihydrochloride Tablets, 5 mg

Antihistamine

24 Hour Relief of:

Sneezing

Runny Nose

Itchy Nose or Throat

Itchy, Watery Eyes

actual size

80 TABLETS

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 printed foil under cap is broken or missing

Inactive Ingredients (Inactive ingredients)

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

Questions Or Comments? (Questions or comments?)

1-800-719-9260

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)

Original Prescription Strength

Compare to XYZAL^® Allergy 24HR

active ingredient

Allergy Relief

Levocetirizine Dihydrochloride Tablets, 5 mg

Antihistamine

24 Hour Relief of:

Sneezing

Runny Nose

Itchy Nose or Throat

Itchy, Watery Eyes

actual size

80 TABLETS

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 printed foil under cap is broken or missing", "Inactive ingredients": "hypromellose, lactose monohydrate, magnesium stearate, microcrystalline cellulose, polyethylene glycol, titanium dioxide", "Questions or comments?": "1-800-719-9260", "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": "Original Prescription Strength Compare to XYZAL ® Allergy 24HR active ingredient Allergy Relief Levocetirizine Dihydrochloride Tablets, 5 mg Antihistamine 24 Hour Relief of: Sneezing Runny Nose Itchy Nose or Throat Itchy, Watery Eyes actual size 80 TABLETS"}

Amazon Allergy Relief Drug Facts

Drug Facts

Composition & Product

Identifiers & Packaging

Medication Information

Structured Label Content

Advanced Ingredient Data

Raw Label Data

Additional Information