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Up&up
SPL v1
SPL
SPL Set ID 89acf9af-d8e8-49ea-8e03-1bfb37089ca8
Route
ORAL
Published
Effective Date 2013-06-14
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Cetirizine (1 mg)
Inactive Ingredients
Acetic Acid Glycerin Methylparaben Propylene Glycol Propylparaben Water Sodium Acetate Anhydrous Sucralose

Identifiers & Packaging

Pill Appearance
Color: yellow
Marketing Status
ANDA Active Since 2011-05-20

Description

Drug Facts

Purpose

Antihistamine


Medication Information

Purpose

Antihistamine

Description

Drug Facts

Uses

temporarily relieves these symptoms due to hay fever or other upper respiratory allergies:

  • runny nose
  • itchy, watery eyes
  • sneezing
  • itching of the nose or throat
Section 42229-5

Drug Facts

Section 50565-1

Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center right away. (1-800-222-1222)

Section 50566-9

Stop use and ask a doctor if an allergic reaction to this product occurs. Seek medical help right away.

Section 50567-7

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
Section 50568-5

Ask a doctor or pharmacist before use if you are taking tranquilizers or sedatives.

Section 50569-3

Ask a doctor before use if you have liver or kidney disease. Your doctor should determine if you need a different dose.

Section 50570-1

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.

Section 53414-9

If pregnant or breast-feeding:

  • if breast-feeding: not recommended
  • if pregnant: ask a health professional before use.
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 older 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 ½ teaspoonful (2.5 mL) once daily. If needed, dose can be increased to a maximum of 1 teaspoonful (5 mL) once daily or ½ 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 1-866-923-4914

Active Ingredient

Cetirizine HCl 5 mg

Other Information
  • do not use if carton is opened, or if imprinted safety seal is broken or missing.
  • see bottom panel for expiration date
  • store between 20° to 25°C (68° to 77°F)
Inactive Ingredients

bubble gum artificial flavor, glacial acetic acid, glycerin, methylparaben, propylene glycol, propylparaben, purified water, sodium acetate anhydrous, sucralose

Principal Display Panel 120 Ml Bottle Carton

NDC 11673-106-08

children's

all day

allergy relief

cetirizine hydrochloride

oral solution 1 mg/mL

antihistamine

Compare to active ingredient in

Children's Zyrtec®*

24 hour relief of: sneezing/itchy, watery

eyes/runny nose/itchy throat or nose

indoor and outdoor allergies

dye and sugar free

dosing cup included

up&up

BUBBLEGUM

FLAVOR

AGE

2+


YEARS

4 FL OZ (120 mL)


Structured Label Content

Uses

temporarily relieves these symptoms due to hay fever or other upper respiratory allergies:

  • runny nose
  • itchy, watery eyes
  • sneezing
  • itching of the nose or throat
Section 42229-5 (42229-5)

Drug Facts

Section 50565-1 (50565-1)

Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center right away. (1-800-222-1222)

Section 50566-9 (50566-9)

Stop use and ask a doctor if an allergic reaction to this product occurs. Seek medical help right away.

Section 50567-7 (50567-7)

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
Section 50568-5 (50568-5)

Ask a doctor or pharmacist before use if you are taking tranquilizers or sedatives.

Section 50569-3 (50569-3)

Ask a doctor before use if you have liver or kidney disease. Your doctor should determine if you need a different dose.

Section 50570-1 (50570-1)

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.

Section 53414-9 (53414-9)

If pregnant or breast-feeding:

  • if breast-feeding: not recommended
  • if pregnant: ask a health professional before use.
Purpose

Antihistamine

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 older 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 ½ teaspoonful (2.5 mL) once daily. If needed, dose can be increased to a maximum of 1 teaspoonful (5 mL) once daily or ½ 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 1-866-923-4914

Active Ingredient (Active ingredient)

Cetirizine HCl 5 mg

Other Information (Other information)
  • do not use if carton is opened, or if imprinted safety seal is broken or missing.
  • see bottom panel for expiration date
  • store between 20° to 25°C (68° to 77°F)
Inactive Ingredients (Inactive ingredients)

bubble gum artificial flavor, glacial acetic acid, glycerin, methylparaben, propylene glycol, propylparaben, purified water, sodium acetate anhydrous, sucralose

Principal Display Panel 120 Ml Bottle Carton (PRINCIPAL DISPLAY PANEL - 120 mL Bottle Carton)

NDC 11673-106-08

children's

all day

allergy relief

cetirizine hydrochloride

oral solution 1 mg/mL

antihistamine

Compare to active ingredient in

Children's Zyrtec®*

24 hour relief of: sneezing/itchy, watery

eyes/runny nose/itchy throat or nose

indoor and outdoor allergies

dye and sugar free

dosing cup included

up&up

BUBBLEGUM

FLAVOR

AGE

2+


YEARS

4 FL OZ (120 mL)


Advanced Ingredient Data


Raw Label Data

All Sections (JSON)