Drug Facts

Drug Facts
SPL v3
SPL
SPL Set ID ec81dc4c-74c0-4719-be5d-686d545f4003
Route
ORAL
Published
Effective Date 2019-01-09
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

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 2019-01-25

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

*All trademarks are property of their respective owners. This product is not affiliated with the makers/owners of Zyrtec ®.

Distributed by C.D.M.A., Inc.©

43157 W 9 Mile Rd

Novi, MI 48375

www.qualitychoice.com

Questions: 248-449-9300

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

KEEP THIS CARD FOR COMPLETE WARNINGS AND PRODUCT INFORMATION

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

Principal Display Panel

QC ®

QUALITY CHOICE

NDC 63868-433-25

*Compare to the Active Ingredient in Zyrtec ®

All Day Allergy Relief

Cetirizine HCl Capsules, 10 mg

Antihistamine

Indoor & Outdoor

Allergies

24 Hour Relief of:

Sneezing

Runny N ose

Itchy, Watery Eyes

Itchy Throat or Nose

25 softgels**

(**Liquid-Filled Capsules) 

Front

Back

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.

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)

*All trademarks are property of their respective owners. This product is not affiliated with the makers/owners of Zyrtec ®.

Distributed by C.D.M.A., Inc.©

43157 W 9 Mile Rd

Novi, MI 48375

www.qualitychoice.com

Questions: 248-449-9300

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

KEEP THIS CARD FOR COMPLETE WARNINGS AND PRODUCT INFORMATION

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
  • 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

Principal Display Panel

QC ®

QUALITY CHOICE

NDC 63868-433-25

*Compare to the Active Ingredient in Zyrtec ®

All Day Allergy Relief

Cetirizine HCl Capsules, 10 mg

Antihistamine

Indoor & Outdoor

Allergies

24 Hour Relief of:

Sneezing

Runny N ose

Itchy, Watery Eyes

Itchy Throat or Nose

25 softgels**

(**Liquid-Filled Capsules) 

Front

Back

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.

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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