Cetirizine Tablets 10 Mg

Drug Facts

Composition & Product

Active Ingredients

Cetirizine (10 mg)

Inactive Ingredients

Anhydrous Lactose Cellulose, Microcrystalline Croscarmellose Sodium Silicon Dioxide Magnesium Stearate Hypromellose 2910 (6 Mpa.s) Titanium Dioxide Polyethylene Glycol 400

Identifiers & Packaging

Pill Appearance

Imprint: C10 Shape: capsule Color: white Size: 9 mm Score: 2

Marketing Status

ANDA Active Since 2024-10-04

Medication Information

Purpose

Antihistamine

Description

Cetirizine HCl 10 mg

Use(s)

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

• runny nose

• sneezing

• itchy, watery eyes

• itching of the nose or throat

Warnings

Do not use if you have ever had an allergic reaction to this product or any of its ingredients or to an antihistamine containing hydroxyzine.

Ask a doctor before use if you have liver or kidney disease. Your doctor should determine if you need a different dose.

Ask a doctor or pharmacist before use if you are taking tranquilizers or sedatives.

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 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.

Directions

adults and children 6 years and over	one 10 mg tablet once daily; do not take more than one 10 mg tablet in 24 hours. A 5 mg product may be appropriate for less severe symptoms.
adults 65 years and over	ask a doctor
children under 6 years of age	ask a doctor
consumers with liver or kidney disease	ask a doctor

Questions?

Call at +1-855-642-2594

Other Information

store between 20° to 25°C (68° to 77°F)
do not use if foil inner seal is broken or missing
FDA approved dissolution test specifications differ from USP

Active Ingredient(s)

Cetirizine HCl 10 mg

Inactive Ingredients

anhydrous lactose, colloidal silicon dioxide, croscarmellose sodium, hypromellose, magnesium stearate, microcrystalline cellulose, polyethylene glycol, titanium dioxide

Principal Display Panel

Original Prescription Strength

NDC 14445-152-30

Cetirizine Hydrochloride Tablets

ALLERGY

Cetirizine HCl tablets

10 mg /antihistamine

Indoor & Outdoor Allergies

24 hour Relief of

• runny nose

• sneezing

• itchy, watery eyes

• itchy throat or nose

30 Tablets

10 mg each

Container Label:

Carton Label:

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)

Structured Label Content

Use(s) (USE(S))

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

• runny nose

• sneezing

• itchy, watery eyes

• itching of the nose or throat

Purpose (PURPOSE)

Antihistamine

Warnings (WARNINGS)

Do not use if you have ever had an allergic reaction to this product or any of its ingredients or to an antihistamine containing hydroxyzine.

Ask a doctor before use if you have liver or kidney disease. Your doctor should determine if you need a different dose.

Ask a doctor or pharmacist before use if you are taking tranquilizers or sedatives.

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 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.

Directions (DIRECTIONS)

adults and children 6 years and over	one 10 mg tablet once daily; do not take more than one 10 mg tablet in 24 hours. A 5 mg product may be appropriate for less severe symptoms.
adults 65 years and over	ask a doctor
children under 6 years of age	ask a doctor
consumers with liver or kidney disease	ask a doctor

Questions?

Call at +1-855-642-2594

Other Information (Other information)

store between 20° to 25°C (68° to 77°F)
do not use if foil inner seal is broken or missing
FDA approved dissolution test specifications differ from USP

Active Ingredient(s) (ACTIVE INGREDIENT(S))

Cetirizine HCl 10 mg

Inactive Ingredients (Inactive ingredients)

anhydrous lactose, colloidal silicon dioxide, croscarmellose sodium, hypromellose, magnesium stearate, microcrystalline cellulose, polyethylene glycol, titanium dioxide

Principal Display Panel (PRINCIPAL DISPLAY PANEL)

Original Prescription Strength

NDC 14445-152-30

Cetirizine Hydrochloride Tablets

ALLERGY

Cetirizine HCl tablets

10 mg /antihistamine

Indoor & Outdoor Allergies

24 hour Relief of

• runny nose

• sneezing

• itchy, watery eyes

• itchy throat or nose

30 Tablets

10 mg each

Container Label:

Carton Label:

Keep Out of Reach of Children (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)

Advanced Ingredient Data

[{"name": "CETIRIZINE", "unii": "YO7261ME24", "classCode": "ACTIB", "strengthNumerator": "10", "strengthDenominator": "1", "strengthNumeratorUnit": "mg", "strengthDenominatorUnit": "1"}, {"name": "ANHYDROUS LACTOSE", "unii": "3SY5LH9PMK", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "CELLULOSE, MICROCRYSTALLINE", "unii": "OP1R32D61U", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "CROSCARMELLOSE SODIUM", "unii": "M28OL1HH48", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "SILICON DIOXIDE", "unii": "ETJ7Z6XBU4", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "MAGNESIUM STEARATE", "unii": "70097M6I30", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "HYPROMELLOSE 2910 (6 MPA.S)", "unii": "0WZ8WG20P6", "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": ""}]

Raw Label Data

All Sections (JSON)

{"USE(S)": "temporarily relieves these symptoms due to hay fever or other upper respiratory allergies: • runny nose • sneezing • itchy, watery eyes • itching of the nose or throat", "PURPOSE": "Antihistamine", "WARNINGS": "Do not use if you have ever had an allergic reaction to this product or any of its ingredients or to an antihistamine containing hydroxyzine. Ask a doctor before use if you have liver or kidney disease. Your doctor should determine if you need a different dose. Ask a doctor or pharmacist before use if you are taking tranquilizers or sedatives. 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 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.", "DIRECTIONS": "adults and children 6 years and over one 10 mg tablet once daily; do not take more than one 10 mg tablet in 24 hours. A 5 mg product may be appropriate for less severe symptoms. adults 65 years and over ask a doctor children under 6 years of age ask a doctor consumers with liver or kidney disease ask a doctor", "Questions?": "Call at +1-855-642-2594", "Other information": "store between 20° to 25°C (68° to 77°F) do not use if foil inner seal is broken or missing FDA approved dissolution test specifications differ from USP", "ACTIVE INGREDIENT(S)": "Cetirizine HCl 10 mg", "Inactive ingredients": "anhydrous lactose, colloidal silicon dioxide, croscarmellose sodium, hypromellose, magnesium stearate, microcrystalline cellulose, polyethylene glycol, titanium dioxide", "PRINCIPAL DISPLAY PANEL": "Original Prescription Strength NDC 14445-152-30 Cetirizine Hydrochloride Tablets ALLERGY Cetirizine HCl tablets 10 mg /antihistamine Indoor & Outdoor Allergies 24 hour Relief of • runny nose • sneezing • itchy, watery eyes • itchy throat or nose 30 Tablets 10 mg each Container Label: Carton Label: ", "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)"}

Drug Facts

Composition & Product

Identifiers & Packaging

Medication Information

Structured Label Content

Advanced Ingredient Data

Raw Label Data

Additional Information