Cetirizine Hydrochloride Tablets

SPL v4

SPL

SPL Set ID c8016d34-aa72-4857-b5ed-5476948b386a

Route

ORAL

Published

Effective Date 2026-02-20

Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients

Cetirizine (10 mg)

Inactive Ingredients

Gelatin Glycerin Mannitol Polyethylene Glycol 400 Water Sodium Hydroxide Sorbitan Sorbitol Butylated Hydroxytoluene

Identifiers & Packaging

Pill Appearance

Imprint: C10 Shape: oval Color: yellow Size: 13 mm Score: 1

Marketing Status

ANDA Completed Since 2021-12-30 Until 2027-10-28

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 or throat

Directions

Adults and children 6 years and over	One 10 mg capsule once daily; do not take more than one 10 mg capsule 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

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.

Product Label

Equate Allergy Relief front panel

Equate Allergy Relief Drug Facts Panel

Other Information

store at 20^o- 25^o C (68^o to 77^o F)
avoid high humidity and excessive heat above 40^oC (104^o F)
protect from light
swallow whole; do not crush, chew, or dissolve

Inactive Ingredients

Butylated hydroxytolene, gelatin, glycerin, mannitol, pharmaceutical ink, polyethylene glycol 400, purified water, sodium hydroxide, Sorbitan, Sorbitol

Questions Or Comments?

Call 1-877-753-3935 Monday-Friday 9AM-5PM EST

Principal Display Panel

ORIGINAL PRESCRIPTION STRENGTH

24 Hour Allergy

Cetirizine HCI Capsules 10 mg

Antihistamine

Compare to Zyrtec® active ingredient≠≠

Relieves symptoms associated with allergies

24 hour relief of runny nose, sneezing, itchy throat or nose & itchy watery eyes

SOFTGELS

(**Liquid-Filled Capsules)

INDOOR & OUTDOOR ALLERGIES

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

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

KEEP OUTER CARD FOR COMPLETE WARNINGS AND PRODUCT INFORMATION.

DISTRIBUTED BY: WALGREEN CO.

200 WILMOT RD., DEERFIELD, IL 60015

When Using This Product

drowsiness may occur
alcohol, sedatives, and tranquilizers may increase drowsiness
avoid alcoholic drinks
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.

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.

Active Ingredient (in Each Capsule)

Cetirizine HCl 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

Purpose

Antihistamine

Directions

Adults and children 6 years and over	One 10 mg capsule once daily; do not take more than one 10 mg capsule 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

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.

Product Label

Equate Allergy Relief front panel

Equate Allergy Relief Drug Facts Panel

Other Information

store at 20^o- 25^o C (68^o to 77^o F)
avoid high humidity and excessive heat above 40^oC (104^o F)
protect from light
swallow whole; do not crush, chew, or dissolve

Inactive Ingredients

Butylated hydroxytolene, gelatin, glycerin, mannitol, pharmaceutical ink, polyethylene glycol 400, purified water, sodium hydroxide, Sorbitan, Sorbitol

Questions Or Comments? (Questions or comments?)

Call 1-877-753-3935 Monday-Friday 9AM-5PM EST

Principal Display Panel

ORIGINAL PRESCRIPTION STRENGTH

24 Hour Allergy

Cetirizine HCI Capsules 10 mg

Antihistamine

Compare to Zyrtec® active ingredient≠≠

Relieves symptoms associated with allergies

24 hour relief of runny nose, sneezing, itchy throat or nose & itchy watery eyes

SOFTGELS

(**Liquid-Filled Capsules)

INDOOR & OUTDOOR ALLERGIES

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

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

KEEP OUTER CARD FOR COMPLETE WARNINGS AND PRODUCT INFORMATION.

DISTRIBUTED BY: WALGREEN CO.

200 WILMOT RD., DEERFIELD, IL 60015

When Using This Product (When using this product)

drowsiness may occur
alcohol, sedatives, and tranquilizers may increase drowsiness
avoid alcoholic drinks
be careful when driving a motor vehicle or operating machinery

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 (1-800-222-1222) right away.

Active Ingredient (in Each Capsule) (Active Ingredient (in each capsule))

Cetirizine HCl 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": "CETIRIZINE", "unii": "YO7261ME24", "classCode": "ACTIB", "strengthNumerator": "10", "strengthDenominator": "1", "strengthNumeratorUnit": "mg", "strengthDenominatorUnit": "1"}, {"name": "GELATIN", "unii": "2G86QN327L", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "GLYCERIN", "unii": "PDC6A3C0OX", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "MANNITOL", "unii": "3OWL53L36A", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "POLYETHYLENE GLYCOL 400", "unii": "B697894SGQ", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "WATER", "unii": "059QF0KO0R", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "SODIUM HYDROXIDE", "unii": "55X04QC32I", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "SORBITAN", "unii": "6O92ICV9RU", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "SORBITOL", "unii": "506T60A25R", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "BUTYLATED HYDROXYTOLUENE", "unii": "1P9D0Z171K", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}]

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", "Purpose": "Antihistamine", "Directions": "Adults and children 6 years and over One 10 mg capsule once daily; do not take more than one 10 mg capsule 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", "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.", "Product Label": "Equate Allergy Relief front panel Equate Allergy Relief Drug Facts Panel", "Other Information": "store at 20 o - 25 o C (68 o to 77 o F) avoid high humidity and excessive heat above 40 o C (104 o F) protect from light swallow whole; do not crush, chew, or dissolve", "Inactive Ingredients": "Butylated hydroxytolene, gelatin, glycerin, mannitol, pharmaceutical ink, polyethylene glycol 400, purified water, sodium hydroxide, Sorbitan, Sorbitol", "Questions or comments?": "Call 1-877-753-3935 Monday-Friday 9AM-5PM EST", "Principal Display Panel": "ORIGINAL PRESCRIPTION STRENGTH 24 Hour Allergy Cetirizine HCI Capsules 10 mg Antihistamine Compare to Zyrtec® active ingredient≠≠ Relieves symptoms associated with allergies 24 hour relief of runny nose, sneezing, itchy throat or nose & itchy watery eyes SOFTGELS (**Liquid-Filled Capsules) INDOOR & OUTDOOR ALLERGIES *This product is not manufactured or distributed by McNeil Consumer Healthcare, distributor of Zyrtec®. TAMPER EVIDENT: DO NOT USE IF PRINTED SAFETY SEAL UNDER CAP IS BROKEN OR MISSING. KEEP OUTER CARD FOR COMPLETE WARNINGS AND PRODUCT INFORMATION. DISTRIBUTED BY: WALGREEN CO. 200 WILMOT RD., DEERFIELD, IL 60015 walgreens.com ©2018 Walgreen Co.", "When using this product": "drowsiness may occur alcohol, sedatives, and tranquilizers may increase drowsiness avoid alcoholic drinks 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.", "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.", "Active Ingredient (in each capsule)": "Cetirizine HCl 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: 2026-02-15T12:00:31.903912 · Updated: 2026-03-14T23:13:51.825108