Drug Facts

Drug Facts

SPL v5

SPL

SPL Set ID 2c2c4828-0479-4ff3-b2b0-dde5fa74efaf

Route

ORAL

Published

Effective Date 2022-12-29

Document Type 34390-5 HUMAN OTC DRUG LABEL

Composition & Product

Active Ingredients

Cetirizine (10 mg)

Inactive Ingredients

Fd&c Yellow No. 6 Gelatin Glycerin Mannitol Polyethylene Glycol, Unspecified Water Sodium Hydroxide Sorbitan Sorbitol

Identifiers & Packaging

Pill Appearance

Imprint: CE1 Shape: oval Color: orange Size: 13 mm Score: 1

Marketing Status

NDA Active Since 2019-05-01

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

Section 42229-5

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

KEEP THIS CARTON FOR COMPLETE WARNINGS AND PRODUCT INFORMATION

^†This product is not manufactured or distributed by the owners of Zyrtec®

Manufactured for:

BIONPHARMA

Princeton, NJ 08540

R0921

L0000534

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.

Other Information

store at 20º-25ºC (68º-77ºF)
avoid high humidity and excessive heat above 40ºC (104ºF)
protect from light

Inactive Ingredients

FD&C yellow #6, gelatin, glycerin, mannitol, pharmaceutical ink, polyethylene glycol, purified water, sodium hydroxide, sorbitan, sorbitol

Questions Or Comments?

call toll free 1-888-235-2466(Mon - Fri 9AM - 5PM EST)

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 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.

Principal Display Panel 65's Carton

^† compare tothe active ingredient in Zyrtec ^®

NDC 69452-265-88

a+health ^TM

cetirizine HCl capsules, 10 mg

antihistamine

indoor & outdoor allergies

24 hour relief of:

sneezing
runny nose
itchy, watery eyes
itchy throat or nose

65 softgels**

**liquid-filled capsule

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)

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

KEEP THIS CARTON FOR COMPLETE WARNINGS AND PRODUCT INFORMATION

^†This product is not manufactured or distributed by the owners of Zyrtec®

Manufactured for:

BIONPHARMA

Princeton, NJ 08540

R0921

L0000534

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.

Other Information (Other information)

store at 20º-25ºC (68º-77ºF)
avoid high humidity and excessive heat above 40ºC (104ºF)
protect from light

Inactive Ingredients (Inactive ingredients)

FD&C yellow #6, gelatin, glycerin, mannitol, pharmaceutical ink, polyethylene glycol, purified water, sodium hydroxide, sorbitan, sorbitol

Questions Or Comments? (Questions or comments?)

call toll free 1-888-235-2466(Mon - Fri 9AM - 5PM EST)

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 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.

Principal Display Panel 65's Carton (Principal Display Panel - 65's carton)

^† compare tothe active ingredient in Zyrtec ^®

NDC 69452-265-88

a+health ^TM

cetirizine HCl capsules, 10 mg

antihistamine

indoor & outdoor allergies

24 hour relief of:

sneezing
runny nose
itchy, watery eyes
itchy throat or nose

65 softgels**

**liquid-filled capsule

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": "FD&C YELLOW NO. 6", "unii": "H77VEI93A8", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"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, UNSPECIFIED", "unii": "3WJQ0SDW1A", "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": "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": "TAMPER EVIDENT: DO NOT USE IF IMPRINTED SAFETY SEAL UNDER CAP IS BROKEN OR MISSING KEEP THIS CARTON FOR COMPLETE WARNINGS AND PRODUCT INFORMATION † This product is not manufactured or distributed by the owners of Zyrtec® Manufactured for: BIONPHARMA Princeton, NJ 08540 R0921 L0000534", "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.", "Other information": "store at 20º-25ºC (68º-77ºF) avoid high humidity and excessive heat above 40ºC (104ºF) protect from light", "Inactive ingredients": "FD&C yellow #6, gelatin, glycerin, mannitol, pharmaceutical ink, polyethylene glycol, purified water, sodium hydroxide, sorbitan, sorbitol", "Questions or comments?": "call toll free 1-888-235-2466 (Mon - Fri 9AM - 5PM EST)", "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 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.", "Principal Display Panel - 65's carton": "† compare to the active ingredient in Zyrtec ® NDC 69452-265-88 a+health TM cetirizine HCl capsules, 10 mg antihistamine indoor & outdoor allergies 24 hour relief of: sneezing runny nose itchy, watery eyes itchy throat or nose 65 softgels** **liquid-filled capsule", "Ask a doctor or pharmacist before use if you are": "taking tranquilizers or sedatives."}

Additional Information

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Source: dailymed · Ingested: 2026-02-15T12:07:42.465982 · Updated: 2026-03-14T23:11:27.729526