DailyMed - DailyMed Details

Drug Facts

Composition & Product

Active Ingredients

Cetirizine (1 mg)

Inactive Ingredients

Acetic Acid Glycerin Methylparaben Propylene Glycol Propylparaben Water Sodium Acetate Sucrose

Identifiers & Packaging

Pill Appearance

Color: yellow

Marketing Status

ANDA Active Since 2014-11-20

Medication Information

Purpose

Antihistamine

Description

Cetirizine Hydrochloride USP 5 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

Warnings

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.

Directions

use only with enclosed dosing cup

adults and children 6 years and over	1 teaspoonful (5 mL) or 2 teaspoonfuls (10 mL) once daily depending upon severity of symptoms; do not take more than 2 teaspoonfuls (10 mL) in 24 hours.
adults 65 years and over	1 teaspoonful (5 mL) once daily; do not take more than 1 teaspoonful (5 mL) in 24 hours.
children 2 to under 6 years of age	1/2 teaspoonful (2.5 mL) once daily. If needed, dose can be increased to a maximum of 1 teaspoonful (5 mL) once daily or 1/2 teaspoonful (2.5 mL) every 12 hours. Do not give more than 1 teaspoonful (5 mL) in 24 hours.
children under 2 years of age	ask a doctor
consumers with liver or kidney disease	ask a doctor

Questions?

call 248-449-9300

Distributed by:

C.D.M.A, Inc.©

43157 W.Nine Mile

Novi.MI 48376-0995

www.qualitychoice.com

Questions: 248-449-9300

Other Information

store between 20° to 25° C (68° to 77°F)

Inactive Ingredients

banana flavor, glacial acetic acid, glycerin, grape flavor, methylparaben, propylene glycol, propylparaben, purified water, sodium acetate, sucrose

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 right away.

Ask A Doctor Before Use If You Have

liver or kidney disease. Your doctor should determine if you need a different dose.

Active Ingredient (in Each 5 Ml Teaspoonful)

Cetirizine Hydrochloride USP 5 mg

Ask A Doctor Or Pharmacist Before Use If You Are

taking tranquilizers or sedatives.

Package Label Principal Display Panel 4 Fl Oz (120 Ml Bottle)

NDC 63868-865-04

*Compare to the

active ingredient in

Children's ZYRTEC®

Children's

Allergy

Relief

Indoor & Outdoor

Allergies

Cetirizine Hydrochloride

Oral Solution, USP 1mg/mL

Antihistamine

For Relief of:

Runny Nose | Sneezing

Itchy, Watery Eyes |

Itchy Nose or Throat

2 yrs. & older

Grape

Flavor

Dosing Cup

Included

4 FL OZ (120 mL)

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

Warnings

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.

Directions

use only with enclosed dosing cup

adults and children 6 years and over	1 teaspoonful (5 mL) or 2 teaspoonfuls (10 mL) once daily depending upon severity of symptoms; do not take more than 2 teaspoonfuls (10 mL) in 24 hours.
adults 65 years and over	1 teaspoonful (5 mL) once daily; do not take more than 1 teaspoonful (5 mL) in 24 hours.
children 2 to under 6 years of age	1/2 teaspoonful (2.5 mL) once daily. If needed, dose can be increased to a maximum of 1 teaspoonful (5 mL) once daily or 1/2 teaspoonful (2.5 mL) every 12 hours. Do not give more than 1 teaspoonful (5 mL) in 24 hours.
children under 2 years of age	ask a doctor
consumers with liver or kidney disease	ask a doctor

Questions?

call 248-449-9300

Distributed by:

C.D.M.A, Inc.©

43157 W.Nine Mile

Novi.MI 48376-0995

www.qualitychoice.com

Questions: 248-449-9300

Other Information (Other information)

store between 20° to 25° C (68° to 77°F)

Inactive Ingredients (Inactive ingredients)

banana flavor, glacial acetic acid, glycerin, grape flavor, methylparaben, propylene glycol, propylparaben, purified water, sodium acetate, sucrose

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 right away.

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.

Active Ingredient (in Each 5 Ml Teaspoonful) (Active ingredient (in each 5 mL teaspoonful))

Cetirizine Hydrochloride USP 5 mg

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

taking tranquilizers or sedatives.

Package Label Principal Display Panel 4 Fl Oz (120 Ml Bottle) (PACKAGE LABEL- PRINCIPAL DISPLAY PANEL 4 FL OZ (120 mL Bottle))

NDC 63868-865-04

*Compare to the

active ingredient in

Children's ZYRTEC®

Children's

Allergy

Relief

Indoor & Outdoor

Allergies

Cetirizine Hydrochloride

Oral Solution, USP 1mg/mL

Antihistamine

For Relief of:

Runny Nose | Sneezing

Itchy, Watery Eyes |

Itchy Nose or Throat

2 yrs. & older

Grape

Flavor

Dosing Cup

Included

4 FL OZ (120 mL)

Advanced Ingredient Data

[{"name": "CETIRIZINE", "unii": "YO7261ME24", "classCode": "ACTIB", "strengthNumerator": "1", "strengthDenominator": "1", "strengthNumeratorUnit": "mg", "strengthDenominatorUnit": "mL"}, {"name": "ACETIC ACID", "unii": "Q40Q9N063P", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "GLYCERIN", "unii": "PDC6A3C0OX", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "METHYLPARABEN", "unii": "A2I8C7HI9T", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "PROPYLENE GLYCOL", "unii": "6DC9Q167V3", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "PROPYLPARABEN", "unii": "Z8IX2SC1OH", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "WATER", "unii": "059QF0KO0R", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "SODIUM ACETATE", "unii": "4550K0SC9B", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "SUCROSE", "unii": "C151H8M554", "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", "Warnings": "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.", "Directions": "use only with enclosed dosing cup adults and children 6 years and over 1 teaspoonful (5 mL) or 2 teaspoonfuls (10 mL) once daily depending upon severity of symptoms; do not take more than 2 teaspoonfuls (10 mL) in 24 hours. adults 65 years and over 1 teaspoonful (5 mL) once daily; do not take more than 1 teaspoonful (5 mL) in 24 hours. children 2 to under 6 years of age 1/2 teaspoonful (2.5 mL) once daily. If needed, dose can be increased to a maximum of 1 teaspoonful (5 mL) once daily or 1/2 teaspoonful (2.5 mL) every 12 hours. Do not give more than 1 teaspoonful (5 mL) in 24 hours. children under 2 years of age ask a doctor consumers with liver or kidney disease ask a doctor", "Questions?": "call 248-449-9300 Distributed by: C.D.M.A, Inc.© 43157 W.Nine Mile Novi.MI 48376-0995 www.qualitychoice.com Questions: 248-449-9300", "Other information": "store between 20° to 25° C (68° to 77°F)", "Inactive ingredients": "banana flavor, glacial acetic acid, glycerin, grape flavor, methylparaben, propylene glycol, propylparaben, purified water, sodium acetate, sucrose", "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 right away.", "Ask a doctor before use if you have": "liver or kidney disease. Your doctor should determine if you need a different dose.", "Active ingredient (in each 5 mL teaspoonful)": "Cetirizine Hydrochloride USP 5 mg", "Ask a doctor or pharmacist before use if you are": "taking tranquilizers or sedatives.", "PACKAGE LABEL- PRINCIPAL DISPLAY PANEL 4 FL OZ (120 mL Bottle)": "NDC 63868-865-04 *Compare to the active ingredient in Children's ZYRTEC® Children's Allergy Relief Indoor & Outdoor Allergies Cetirizine Hydrochloride Oral Solution, USP 1mg/mL Antihistamine For Relief of: Runny Nose | Sneezing Itchy, Watery Eyes | Itchy Nose or Throat 2 yrs. & older Grape Flavor Dosing Cup Included 4 FL OZ (120 mL)"}

Drug Facts

Composition & Product

Identifiers & Packaging

Medication Information

Structured Label Content

Advanced Ingredient Data

Raw Label Data

Additional Information