All Day

All Day
SPL v3
SPL
SPL Set ID 6ce39876-47bf-4147-885d-4eb0aeb66fd0
Route
ORAL
Published
Effective Date 2020-06-18
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Cetirizine (5 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 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 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 1-866-923-4914

Other Information
  • 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

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
Active Ingredient (in Each 5 Ml Teaspoonful)

Cetirizine HCl 5 mg

Principal Display Panel 118 Ml Bottle Carton

NDC 46122-101-26

Compare to

Children's Zyrtec®*

active ingredient

Rx

GOOD

NEIGHBOR

PHARMACY®

2 YEARS & OLDER

Children's

All Day

Allergy

cetirizine hydrochloride

oral solution 1 mg/mL

antihistamine

Indoor & Outdoor

Allergies

24 Hour Relief of:

  • Sneezing • Runny Nose
  • Itchy, Watery Eyes
  • Itchy Throat or Nose

Sugar Free

Bubble Gum Flavor

Dosing Cup Included

4 fl oz

(118 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 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 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 1-866-923-4914

Other Information (Other information)
  • 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

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

Cetirizine HCl 5 mg

Principal Display Panel 118 Ml Bottle Carton (PRINCIPAL DISPLAY PANEL - 118 mL Bottle Carton)

NDC 46122-101-26

Compare to

Children's Zyrtec®*

active ingredient

Rx

GOOD

NEIGHBOR

PHARMACY®

2 YEARS & OLDER

Children's

All Day

Allergy

cetirizine hydrochloride

oral solution 1 mg/mL

antihistamine

Indoor & Outdoor

Allergies

24 Hour Relief of:

  • Sneezing • Runny Nose
  • Itchy, Watery Eyes
  • Itchy Throat or Nose

Sugar Free

Bubble Gum Flavor

Dosing Cup Included

4 fl oz

(118 mL)


Advanced Ingredient Data


Raw Label Data

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