Right Remedies

Right Remedies
SPL v1
SPL
SPL Set ID 8227edbe-88d5-4d79-9175-891dd9566357
Route
ORAL
Published
Effective Date 2025-11-24
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Cetirizine (10 mg)
Inactive Ingredients
Hypromellose, Unspecified Lactose, Unspecified Form Magnesium Stearate Starch, Corn Polyethylene Glycol 400 Povidone, Unspecified Water Titanium Dioxide

Identifiers & Packaging

Marketing Status
ANDA Active Since 2025-11-24

Description

Cetirizine HCl 10 mg

Purpose

Antihistamine


Medication Information

Purpose

Antihistamine

Description

Cetirizine HCl 10 mg

Uses

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

• runny nose            • sneezing 

• itchy, watery eyes  • itching of the nose and throat

Section 42229-5

Compare to the active ingredient

in Original Prescription Strength ZYRTEC ®* 

Treat indoor & outdoor allergies

24-hr relief of:

Sneezing, runny nose,

itchy watery eyes,

itchy throat

READ AND KEEP OUTER CARTON FOR COMPLETE PRODUCT WARNINGS AND INFORMATION

Distributed by: Strive Pharmaceuticals Inc.,

East Brunswick, NJ 08816

PRODUCT OF INDIA

*This product is not manufactured or distributed by McNeil Consumer Healthcare, distributor of ZYRTEC ® .

TAMPER EVIDENT: DO NOT USE IF IMPRINTED  SAFETY SEAL UNDER CAP IS BROKEN OR MISSING

LOT:

EXP:

Section 50565-1

Keep out of reach of children.

Overdose warning: In case of overdose, get medical help or contact a Poison Control Center right away. Prompt medical attention is critical for adults as well as children even if you do not notice any signs or symptoms.

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.

Packaging

Directions
adults & 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  ask a doctor
consumers with liver or kidney disease  ask a doctor

Drug Facts

Other Information

• store at controlled room temperature 20°–25°C (68°-77°F)

• protect from light, heat and moisture

Inactive Ingredients

hypromellose, lactose, magnesium stearate, maize starch, polyethylene glycol 400, povidone, purified water, titanium dioxide

Questions Or Comments?

1-888-577-8033  Monday - Friday 8am - 4pm EST

Active Ingredient (in Each Tablet)

Cetirizine HCl 10 mg


Structured Label Content

Uses

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

• runny nose            • sneezing 

• itchy, watery eyes  • itching of the nose and throat

Section 42229-5 (42229-5)

Compare to the active ingredient

in Original Prescription Strength ZYRTEC ®* 

Treat indoor & outdoor allergies

24-hr relief of:

Sneezing, runny nose,

itchy watery eyes,

itchy throat

READ AND KEEP OUTER CARTON FOR COMPLETE PRODUCT WARNINGS AND INFORMATION

Distributed by: Strive Pharmaceuticals Inc.,

East Brunswick, NJ 08816

PRODUCT OF INDIA

*This product is not manufactured or distributed by McNeil Consumer Healthcare, distributor of ZYRTEC ® .

TAMPER EVIDENT: DO NOT USE IF IMPRINTED  SAFETY SEAL UNDER CAP IS BROKEN OR MISSING

LOT:

EXP:

Section 50565-1 (50565-1)

Keep out of reach of children.

Overdose warning: In case of overdose, get medical help or contact a Poison Control Center right away. Prompt medical attention is critical for adults as well as children even if you do not notice any signs or symptoms.

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.

Packaging

Directions
adults & 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  ask a doctor
consumers with liver or kidney disease  ask a doctor

Drug Facts

Other Information (Other information)

• store at controlled room temperature 20°–25°C (68°-77°F)

• protect from light, heat and moisture

Inactive Ingredients (Inactive ingredients)

hypromellose, lactose, magnesium stearate, maize starch, polyethylene glycol 400, povidone, purified water, titanium dioxide

Questions Or Comments? (Questions or comments?)

1-888-577-8033  Monday - Friday 8am - 4pm EST

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

Cetirizine HCl 10 mg


Advanced Ingredient Data


Raw Label Data

All Sections (JSON)