Drug Facts

Drug Facts

SPL v12

SPL

SPL Set ID bd0dc7f6-5fb9-4381-bd81-b150b75a2c68

Route

ORAL

Published

Effective Date 2021-10-15

Document Type 34390-5 HUMAN OTC DRUG LABEL

Composition & Product

Active Ingredients

Cetirizine (10 mg)

Inactive Ingredients

Anhydrous Lactose Silicon Dioxide Hypromellose, Unspecified Magnesium Stearate Microcrystalline Cellulose Polydextrose Polyethylene Glycol, Unspecified Sodium Lauryl Sulfate Titanium Dioxide Triacetin

Identifiers & Packaging

Pill Appearance

Imprint: M;C37 Shape: round Color: white Size: 8 mm Score: 1

Marketing Status

ANDA Active Since 2012-03-30

Description

CETIRIZINE HCl 10 mg TABLETS, USP Antihistamine Indoor & Outdoor Allergies TAMPER EVIDENT: DO NOT USE IF BLISTER UNITS ARE TORN, BROKEN OR SHOW ANY SIGNS OF TAMPERING.

Purpose

Antihistamine

How Supplied

Cetirizine Hydrochloride Tablets, USP are available as follows: 10 mg - White, film-coated, round, biconvex, beveled edge, unscored tablets debossed with M on one side of the tablet and C37 on the other side. NDC 51079-597-20 - Unit dose blister packages of 100 (10 cards of 10 tablets each). Store at 20° to 25°C (68° to 77°F). [See USP Controlled Room Temperature.] Manufactured for: Mylan Pharmaceuticals Inc. Morgantown, WV 26505 U.S.A. Made in India Code No.: MH/DRUGS/25/NKD/89 Distributed by: Mylan Institutional Inc. Rockford, IL 61103 U.S.A. S-12769 10/21

Medication Information

Purpose

Antihistamine

How Supplied

Cetirizine Hydrochloride Tablets, USP are available as follows:

10 mg - White, film-coated, round, biconvex, beveled

edge, unscored tablets debossed with M on one side of

the tablet and C37 on the other side.

NDC 51079-597-20 - Unit dose blister packages

of 100 (10 cards of 10 tablets each).

Store at 20° to 25°C (68° to 77°F). [See USP Controlled Room Temperature.]

Manufactured for:

Mylan Pharmaceuticals Inc.

Morgantown, WV 26505 U.S.A.

Made in India

Code No.: MH/DRUGS/25/NKD/89

Distributed by:

Mylan Institutional Inc.

Rockford, IL 61103 U.S.A.

S-12769

10/21

Description

CETIRIZINE HCl 10 mg TABLETS, USP Antihistamine Indoor & Outdoor Allergies TAMPER EVIDENT: DO NOT USE IF BLISTER UNITS ARE TORN, BROKEN OR SHOW ANY SIGNS OF TAMPERING.

Uses

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

Section 42229-5

CETIRIZINE HCl

10 mg TABLETS, USP

Antihistamine

Indoor & Outdoor Allergies

TAMPER EVIDENT: DO NOT USE IF BLISTER UNITS ARE TORN, BROKEN OR SHOW ANY SIGNS OF TAMPERING.

Section 51945-4

PRINCIPAL DISPLAY PANEL - 10 mg

NDC 51079-597-20

Cetirizine HCl

Tablets, USP

10 mg

Antihistamine

Indoor & Outdoor Allergies

24 Hour Relief

(See Uses section of enclosed leaflet)

TAMPER EVIDENT: DO NOT USE IF BLISTER UNITS ARE

TORN, BROKEN OR SHOW ANY SIGNS OF TAMPERING.

Manufactured for:

Mylan Pharmaceuticals Inc.

Morgantown, WV 26505 U.S.A.

Made in India

S-12721

This unit dose package is not child resistant.
For institutional use only.
Keep this and all drugs out of the reach of children.
This container provides light-resistance.
See window for lot number and expiration date.

Distributed by:

Mylan Institutional Inc.

Rockford, IL 61103 U.S.A.

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.

Other Information

Store at 20° to 25°C (68° to 77°F). [See USP Controlled Room Temperature.]

Inactive Ingredients

Anhydrous lactose, colloidal silicon dioxide, hypromellose, magnesium stearate, microcrystalline cellulose, polydextrose, polyethylene glycol, sodium lauryl sulfate, titanium dioxide, and triacetin

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

Questions? 1 800 848 0462

Serious side effects associated with use of this product may be

reported to this number.

Directions (24 Hour Relief)

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

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.

Keep Out of Reach of Children.

In case of overdose, get medical help or contact a Poison Control Center right away.

Active Ingredient (in Each Tablet)

Cetirizine Hydrochloride, USP 10 mg

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.

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 or throat

Section 42229-5 (42229-5)

CETIRIZINE HCl

10 mg TABLETS, USP

Antihistamine

Indoor & Outdoor Allergies

TAMPER EVIDENT: DO NOT USE IF BLISTER UNITS ARE TORN, BROKEN OR SHOW ANY SIGNS OF TAMPERING.

Section 51945-4 (51945-4)

PRINCIPAL DISPLAY PANEL - 10 mg

NDC 51079-597-20

Cetirizine HCl

Tablets, USP

10 mg

Antihistamine

Indoor & Outdoor Allergies

24 Hour Relief

(See Uses section of enclosed leaflet)

TAMPER EVIDENT: DO NOT USE IF BLISTER UNITS ARE

TORN, BROKEN OR SHOW ANY SIGNS OF TAMPERING.

Manufactured for:

Mylan Pharmaceuticals Inc.

Morgantown, WV 26505 U.S.A.

Made in India

S-12721

This unit dose package is not child resistant.
For institutional use only.
Keep this and all drugs out of the reach of children.
This container provides light-resistance.
See window for lot number and expiration date.

Distributed by:

Mylan Institutional Inc.

Rockford, IL 61103 U.S.A.

Purpose

Antihistamine

Do Not Use (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.

How Supplied (HOW SUPPLIED)

Cetirizine Hydrochloride Tablets, USP are available as follows:

10 mg - White, film-coated, round, biconvex, beveled

edge, unscored tablets debossed with M on one side of

the tablet and C37 on the other side.

NDC 51079-597-20 - Unit dose blister packages

of 100 (10 cards of 10 tablets each).

Store at 20° to 25°C (68° to 77°F). [See USP Controlled Room Temperature.]

Manufactured for:

Mylan Pharmaceuticals Inc.

Morgantown, WV 26505 U.S.A.

Made in India

Code No.: MH/DRUGS/25/NKD/89

Distributed by:

Mylan Institutional Inc.

Rockford, IL 61103 U.S.A.

S-12769

10/21

Other Information (Other information)

Store at 20° to 25°C (68° to 77°F). [See USP Controlled Room Temperature.]

Inactive Ingredients (Inactive ingredients)

Anhydrous lactose, colloidal silicon dioxide, hypromellose, magnesium stearate, microcrystalline cellulose, polydextrose, polyethylene glycol, sodium lauryl sulfate, titanium dioxide, and triacetin

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

Questions? 1 800 848 0462 (Questions? 1-800-848-0462)

Serious side effects associated with use of this product may be

reported to this number.

Directions (24 Hour Relief)

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

Stop Use and Ask A Doctor If (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 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.

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

Cetirizine Hydrochloride, USP 10 mg

Ask A Doctor Before Use If You Have (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 (Ask a doctor or pharmacist before use if you are)

taking tranquilizers or sedatives.

Advanced Ingredient Data

[{"name": "ANHYDROUS LACTOSE", "unii": "3SY5LH9PMK", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "SILICON DIOXIDE", "unii": "ETJ7Z6XBU4", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "HYPROMELLOSE, UNSPECIFIED", "unii": "3NXW29V3WO", "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": "POLYDEXTROSE", "unii": "VH2XOU12IE", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "POLYETHYLENE GLYCOL, UNSPECIFIED", "unii": "3WJQ0SDW1A", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "SODIUM LAURYL SULFATE", "unii": "368GB5141J", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "TITANIUM DIOXIDE", "unii": "15FIX9V2JP", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "TRIACETIN", "unii": "XHX3C3X673", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "CETIRIZINE", "unii": "YO7261ME24", "classCode": "ACTIB", "strengthNumerator": "10", "strengthDenominator": "1", "strengthNumeratorUnit": "mg", "strengthDenominatorUnit": "1"}]

Raw Label Data

All Sections (JSON)

{"Uses": "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", "42229-5": "CETIRIZINE HCl 10 mg TABLETS, USP Antihistamine Indoor & Outdoor Allergies TAMPER EVIDENT: DO NOT USE IF BLISTER UNITS ARE TORN, BROKEN OR SHOW ANY SIGNS OF TAMPERING.", "51945-4": "PRINCIPAL DISPLAY PANEL - 10 mg NDC 51079-597-20 Cetirizine HCl Tablets, USP 10 mg Antihistamine Indoor & Outdoor Allergies 24 Hour Relief (See Uses section of enclosed leaflet) TAMPER EVIDENT: DO NOT USE IF BLISTER UNITS ARE TORN, BROKEN OR SHOW ANY SIGNS OF TAMPERING. Manufactured for: Mylan Pharmaceuticals Inc. Morgantown, WV 26505 U.S.A. Made in India S-12721 This unit dose package is not child resistant. For institutional use only. Keep this and all drugs out of the reach of children. This container provides light-resistance. See window for lot number and expiration date. Distributed by: Mylan Institutional Inc. Rockford, IL 61103 U.S.A.", "Purpose": "Antihistamine", "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.", "HOW SUPPLIED": "Cetirizine Hydrochloride Tablets, USP are available as follows: 10 mg - White, film-coated, round, biconvex, beveled edge, unscored tablets debossed with M on one side of the tablet and C37 on the other side. NDC 51079-597-20 - Unit dose blister packages of 100 (10 cards of 10 tablets each). Store at 20° to 25°C (68° to 77°F). [See USP Controlled Room Temperature.] Manufactured for: Mylan Pharmaceuticals Inc. Morgantown, WV 26505 U.S.A. Made in India Code No.: MH/DRUGS/25/NKD/89 Distributed by: Mylan Institutional Inc. Rockford, IL 61103 U.S.A. S-12769 10/21", "Other information": "Store at 20° to 25°C (68° to 77°F). [See USP Controlled Room Temperature.]", "Inactive ingredients": "Anhydrous lactose, colloidal silicon dioxide, hypromellose, magnesium stearate, microcrystalline cellulose, polydextrose, polyethylene glycol, sodium lauryl sulfate, titanium dioxide, and triacetin", "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", "Questions? 1-800-848-0462": "Serious side effects associated with use of this product may be reported to this number.", "Directions (24 Hour Relief)": "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", "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.", "Keep out of reach of children.": "In case of overdose, get medical help or contact a Poison Control Center right away.", "Active ingredient (in each tablet)": "Cetirizine Hydrochloride, USP 10 mg", "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."}

Additional Information

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Source: dailymed · Ingested: 2026-02-15T12:06:34.788320 · Updated: 2026-03-14T23:09:25.529071