Curist Allergy Relief Tablet (levocetirizine 5 Mg)

SPL v4

SPL

SPL Set ID feabf140-e283-dcd5-e053-6394a90a2917

Route

ORAL

Published

Effective Date 2023-01-19

Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients

Levocetirizine (5 mg)

Inactive Ingredients

Titanium Dioxide Hypromellose 2910 (3 Mpa.s) Polyethylene Glycol 400 Polysorbate 80 Lactose Monohydrate Magnesium Stearate Microcrystalline Cellulose Hypromellose 2910 (6 Mpa.s) Silicon Dioxide

Identifiers & Packaging

Pill Appearance

Imprint: LL;H Shape: oval Color: white Size: 8 mm Score: 2

Marketing Status

ANDA Active Since 2023-01-24

Description

Drug Facts

Medication Information

Warnings and Precautions

Warnings

Indications and Usage

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

Dosage and Administration

Directions

adults 65 years and older	ask a doctor
adults and children 12-64 years	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	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	do not use
consumers with kidney disease	do not use

Description

Drug Facts

Section 42229-5

Drug Facts

Section 44425-7

Other information

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

Section 50565-1

Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center (1-800-222-1222) right away.

Section 50566-9

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.

Section 50567-7

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

Section 50569-3

Ask a doctor before use if you have ever had trouble urinating or emptying your bladder.

Section 50570-1

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

Section 51727-6

Inactive ingredients

colloidal silicon dioxide, hypromellose, lactose monohydrate, magnesium stearate, microcrystalline cellulose, polyethylene glycol, polysorbate 80, titanium dioxide.

Section 51945-4

curist

Allergy Relief

Levocetirizine Dihydrochloride Tablets, USP 5 mg

Antihistamine

24 Hour Relief of Runny Nose; Sneezing; Itchy, Watery Eyes; Itchy Nose or Throat

Clinically Proven Relief in 60 Minutes

90 Tablets

actual size

Section 53413-1

Questions?

Call 1-844-243-1241 or email [email protected]

Section 53414-9

If pregnant or breast-feeding,

if breast-feeding: not recommended
if pregnant: ask a health professional before use

Section 55105-1

Purpose

Antihistamine

Section 55106-9

Active ingredient (in each tablet)

Levocetirizine dihydrochloride USP 5 mg

Structured Label Content

Indications and Usage (34067-9)

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

Dosage and Administration (34068-7)

Directions

adults 65 years and older	ask a doctor
adults and children 12-64 years	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	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	do not use
consumers with kidney disease	do not use

Warnings and Precautions (34071-1)

Warnings

Section 42229-5 (42229-5)

Drug Facts

Section 44425-7 (44425-7)

Other information

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

Section 50565-1 (50565-1)

Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center (1-800-222-1222) right away.

Section 50566-9 (50566-9)

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.

Section 50567-7 (50567-7)

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

Section 50569-3 (50569-3)

Ask a doctor before use if you have ever had trouble urinating or emptying your bladder.

Section 50570-1 (50570-1)

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

Section 51727-6 (51727-6)

Inactive ingredients

colloidal silicon dioxide, hypromellose, lactose monohydrate, magnesium stearate, microcrystalline cellulose, polyethylene glycol, polysorbate 80, titanium dioxide.

Section 51945-4 (51945-4)

curist

Allergy Relief

Levocetirizine Dihydrochloride Tablets, USP 5 mg

Antihistamine

24 Hour Relief of Runny Nose; Sneezing; Itchy, Watery Eyes; Itchy Nose or Throat

Clinically Proven Relief in 60 Minutes

90 Tablets

actual size

Section 53413-1 (53413-1)

Questions?

Call 1-844-243-1241 or email [email protected]

Section 53414-9 (53414-9)

If pregnant or breast-feeding,

if breast-feeding: not recommended
if pregnant: ask a health professional before use

Section 55105-1 (55105-1)

Purpose

Antihistamine

Section 55106-9 (55106-9)

Active ingredient (in each tablet)

Levocetirizine dihydrochloride USP 5 mg

Advanced Ingredient Data

[{"name": "LEVOCETIRIZINE", "unii": "6U5EA9RT2O", "classCode": "ACTIB", "strengthNumerator": "5", "strengthDenominator": "1", "strengthNumeratorUnit": "mg", "strengthDenominatorUnit": "1"}, {"name": "TITANIUM DIOXIDE", "unii": "15FIX9V2JP", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "HYPROMELLOSE 2910 (3 MPA.S)", "unii": "0VUT3PMY82", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "POLYETHYLENE GLYCOL 400", "unii": "B697894SGQ", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "POLYSORBATE 80", "unii": "6OZP39ZG8H", "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": "HYPROMELLOSE 2910 (6 MPA.S)", "unii": "0WZ8WG20P6", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "SILICON DIOXIDE", "unii": "ETJ7Z6XBU4", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}]

Raw Label Data

All Sections (JSON)

{"34067-9": "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", "34068-7": "Directions adults 65 years and older ask a doctor adults and children 12-64 years 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 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 do not use consumers with kidney disease do not use", "34071-1": "Warnings", "42229-5": "Drug Facts", "44425-7": "Other information store between 20° and 25°C (68° and 77°F) safety sealed: do not use if carton was opened or torn, or if printed inner seal on bottle is torn or missing", "50565-1": "Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center (1-800-222-1222) right away.", "50566-9": "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.", "50567-7": "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", "50569-3": "Ask a doctor before use if you have ever had trouble urinating or emptying your bladder.", "50570-1": "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", "51727-6": "Inactive ingredients colloidal silicon dioxide, hypromellose, lactose monohydrate, magnesium stearate, microcrystalline cellulose, polyethylene glycol, polysorbate 80, titanium dioxide.", "51945-4": "curist Allergy Relief Levocetirizine Dihydrochloride Tablets, USP 5 mg Antihistamine 24 Hour Relief of Runny Nose; Sneezing; Itchy, Watery Eyes; Itchy Nose or Throat Clinically Proven Relief in 60 Minutes 90 Tablets actual size", "53413-1": "Questions? Call 1-844-243-1241 or email hi@curistrelief.com", "53414-9": "If pregnant or breast-feeding, if breast-feeding: not recommended if pregnant: ask a health professional before use", "55105-1": "Purpose Antihistamine", "55106-9": "Active ingredient (in each tablet) Levocetirizine dihydrochloride USP 5 mg"}

Additional Information

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Source: dailymed · Ingested: 2026-02-15T12:05:55.743356 · Updated: 2026-03-14T23:08:22.901159