Cetirizine Hydrochloride Tablets

Cetirizine Hydrochloride Tablets
SPL v2
SPL
SPL Set ID 04a6087e-d854-4e70-9d89-3971890a44a3
Route
ORAL
Published
Effective Date 2022-10-20
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 Active Since 2018-04-30

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
CARE ONE Allergy Relief
Other Information
  • store at 20º to 25oC (68o to 77oF)
  • avoid high humidity and excessive heat above 40o C (104o F)
  • protect from light
Inactive Ingredients

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

*may contain this ingredient

Questions Or Comments?

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

Principal Display Panel

Compare to the active ingredient in Zyrtex® Liquid Gels†

Allergy Relief

Cetirizine HCI CAPSULES, 10 mg

Antihistamine

FOR ALLERGY RELIEF OF

  • Sneezing
  • Runny nose
  • Itchy, watery eyes
  • Itchy throat or nose

SOFTGELS**

(**LIQUID-FILLED CAPSULES)

*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 CARTON FOR COMPLETE WARNINGS AND PRODUCT INFORMATION.

DISTRIBUTED BY:

ADUSA DISTRIBUTION, LLC

SALISBURY, NC 28147

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.
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
CARE ONE Allergy Relief
Other Information
  • store at 20º to 25oC (68o to 77oF)
  • avoid high humidity and excessive heat above 40o C (104o F)
  • protect from light
Inactive Ingredients

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

*may contain this ingredient

Questions Or Comments? (Questions or comments?)

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

Principal Display Panel

Compare to the active ingredient in Zyrtex® Liquid Gels†

Allergy Relief

Cetirizine HCI CAPSULES, 10 mg

Antihistamine

FOR ALLERGY RELIEF OF

  • Sneezing
  • Runny nose
  • Itchy, watery eyes
  • Itchy throat or nose

SOFTGELS**

(**LIQUID-FILLED CAPSULES)

*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 CARTON FOR COMPLETE WARNINGS AND PRODUCT INFORMATION.

DISTRIBUTED BY:

ADUSA DISTRIBUTION, LLC

SALISBURY, NC 28147

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
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


Raw Label Data

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