Drug Facts

Composition & Product

Active Ingredients

Cetirizine (10 mg)

Inactive Ingredients

Silicon Dioxide Hypromellose, Unspecified Lactose Monohydrate Magnesium Stearate Microcrystalline Cellulose Polyethylene Glycol, Unspecified Povidone K30 Sodium Starch Glycolate Type A Titanium Dioxide

Identifiers & Packaging

Pill Appearance

Imprint: C;17 Shape: round Color: white Size: 8 mm Score: 1

Marketing Status

ANDA Active Since 2025-03-01

Medication Information

Warnings and Precautions

Do not use if you have ever had an allergic reaction to this product or any of its ingredients or 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 breastfeeding:

•
If breastfeeding: not recommended
•
if pregnant: ask a health professional before use.

Indications and Usage

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

Dosage and Administration

Cetirizine Hydrochloride Tablets, USP 10 mg

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

Description

Cetirizine HCl 10 mg

Section 51727-6

colloidal silicon dioxide, hypromellose, lactose monohydrate, magnesium stearate, microcrystalline cellulose, polyethylene glycol, povidone, sodium starch glycolate, titanium dioxide.

Section 55105-1

Antihistamine

Section 55106-9

Cetirizine HCl 10 mg

Section 60561-8

Questions or comments?

Call 833-358-6431 Monday to Friday 9:00am to 7:00pm EST

Manufactured by:

Glenmark Pharmaceuticals Limited

Pithampur, Madhya Pradesh 454775, India

Distributed by:

McKesson Corp. via SSSL

Memphis, TN 38141

www.fosterandthrive.com

Product of India

April 2025

Other Information

•
store between 20°C to 25°C (68°F to 77°F)
•
do not use if imprinted foil inner seal on bottle is broken or missing.
•
FDA approved organic impurities test procedure differs from USP

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).

Package/label Principal Display Panel

Container label

NDC 70677-1279-5

10 mg - 300 Tablets

Structured Label Content

Indications and Usage (34067-9)

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

Dosage and Administration (34068-7)

Cetirizine Hydrochloride Tablets, USP 10 mg

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

Warnings and Precautions (34071-1)

Do not use if you have ever had an allergic reaction to this product or any of its ingredients or 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 breastfeeding:

•
If breastfeeding: not recommended
•
if pregnant: ask a health professional before use.

Section 51727-6 (51727-6)

colloidal silicon dioxide, hypromellose, lactose monohydrate, magnesium stearate, microcrystalline cellulose, polyethylene glycol, povidone, sodium starch glycolate, titanium dioxide.

Section 55105-1 (55105-1)

Antihistamine

Section 55106-9 (55106-9)

Cetirizine HCl 10 mg

Section 60561-8 (60561-8)

Questions or comments?

Call 833-358-6431 Monday to Friday 9:00am to 7:00pm EST

Manufactured by:

Glenmark Pharmaceuticals Limited

Pithampur, Madhya Pradesh 454775, India

Distributed by:

McKesson Corp. via SSSL

Memphis, TN 38141

www.fosterandthrive.com

Product of India

April 2025

Other Information (Other information)

•
store between 20°C to 25°C (68°F to 77°F)
•
do not use if imprinted foil inner seal on bottle is broken or missing.
•
FDA approved organic impurities test procedure differs from USP

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).

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

Container label

NDC 70677-1279-5

10 mg - 300 Tablets

Advanced Ingredient Data

[{"name": "CETIRIZINE", "unii": "YO7261ME24", "classCode": "ACTIB", "strengthNumerator": "10", "strengthDenominator": "1", "strengthNumeratorUnit": "mg", "strengthDenominatorUnit": "1"}, {"name": "SILICON DIOXIDE", "unii": "ETJ7Z6XBU4", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"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": "POVIDONE K30", "unii": "U725QWY32X", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "SODIUM STARCH GLYCOLATE TYPE A", "unii": "H8AV0SQX4D", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "TITANIUM DIOXIDE", "unii": "15FIX9V2JP", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}]

Raw Label Data

All Sections (JSON)

{"34067-9": "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", "34068-7": "Cetirizine Hydrochloride Tablets, USP 10 mg 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", "34071-1": "Do not use if you have ever had an allergic reaction to this product or any of its ingredients or 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 breastfeeding: • If breastfeeding: not recommended • if pregnant: ask a health professional before use.", "51727-6": "colloidal silicon dioxide, hypromellose, lactose monohydrate, magnesium stearate, microcrystalline cellulose, polyethylene glycol, povidone, sodium starch glycolate, titanium dioxide.", "55105-1": "Antihistamine", "55106-9": "Cetirizine HCl 10 mg", "60561-8": "Questions or comments? Call 833-358-6431 Monday to Friday 9:00am to 7:00pm EST Manufactured by: Glenmark Pharmaceuticals Limited Pithampur, Madhya Pradesh 454775, India Distributed by: McKesson Corp. via SSSL Memphis, TN 38141 www.fosterandthrive.com Product of India April 2025", "Other information": "• store between 20°C to 25°C (68°F to 77°F) • do not use if imprinted foil inner seal on bottle is broken or missing. • FDA approved organic impurities test procedure differs from USP", "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).", "Package/Label Principal Display Panel": "Container label NDC 70677-1279-5 10 mg - 300 Tablets"}

Drug Facts

Drug Facts

Composition & Product

Identifiers & Packaging

Medication Information

Structured Label Content

Advanced Ingredient Data

Raw Label Data

Additional Information