a6492645-8438-4e82-aa31-7e5b4bccb220

SPL v8
SPL
SPL Set ID a6492645-8438-4e82-aa31-7e5b4bccb220
Route
oral
Published
Effective Date 2023-12-15
Document Type 34390-5 Human OTC Drug Label

Drug Facts

Composition & Product

Active Ingredients
cetirizine (1 mg)
Inactive Ingredients
anhydrous citric acid sorbitol propylene glycol water sodium benzoate sucralose

Identifiers & Packaging

Pill Appearance
Color: yellow
Marketing Status
anda active Since 2019-03-13
Purpose

Antihistamine

Description

(in each 5 mL) Cetirizine Hydrochloride USP 5mg

Medication Information

Purpose

Antihistamine

Directions


  • use only with enclosed dosing cup
  • find right dose on chart below
  • mL = milliliter




adults and children 6 years and over

5 mL or 10 mL once daily depending upon severity of symptoms; do not take more than 10 mL in 24 hours.
adults 65 years and over

 5 mL once daily; do not take more than 5 mL in                  24 hours.
children 2 to under 6 years of age

 2.5 mL once daily. If needed, dose can be increased to a maximum of 5 mL once daily or 2.5 mL every                   12 hours. Do not give more than 5 mL in 24 hours
children under 2 years of age

 ask a doctor
consumers with liver or kidney disease

 ask a doctor


Other Information
  • store between 20° to 25°C (68° to 77°F)
  • do not use if carton is opened or bottle wrap imprinted “SAFETY SEAL®” is broken or missing
  • see top panel for lot number and expiration date
Inactive Ingredients

anhydrous citric acid, flavors, non crystallizing sorbitol solution, propylene glycol, purified water, sodium benzoate and sucralose.

Description

(in each 5 mL) Cetirizine Hydrochloride USP 5mg

Questions?

call 1-888-588-1418

                                              

Distributed by:

Camber Consumer Care, Inc.

Piscataway, NJ 08854, USA.



Mfg. Lic. No.: 22/RR/AP/2001/F/R





Use(s)

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
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.

Active Ingredient(s)

(in each 5 mL)

Cetirizine Hydrochloride USP 5mg



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
Cetirizine Hydrochloride
Ask A Doctor Before Use If

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

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 (1-800-222-1222).

Ask A Doctor Or Pharmacist Before Use If

you are taking tranquilizers or sedatives.

Structured Label Content

Purpose (PURPOSE)

Antihistamine

Directions (DIRECTIONS)


  • use only with enclosed dosing cup
  • find right dose on chart below
  • mL = milliliter




adults and children 6 years and over

5 mL or 10 mL once daily depending upon severity of symptoms; do not take more than 10 mL in 24 hours.
adults 65 years and over

 5 mL once daily; do not take more than 5 mL in                  24 hours.
children 2 to under 6 years of age

 2.5 mL once daily. If needed, dose can be increased to a maximum of 5 mL once daily or 2.5 mL every                   12 hours. Do not give more than 5 mL in 24 hours
children under 2 years of age

 ask a doctor
consumers with liver or kidney disease

 ask a doctor


Other Information
  • store between 20° to 25°C (68° to 77°F)
  • do not use if carton is opened or bottle wrap imprinted “SAFETY SEAL®” is broken or missing
  • see top panel for lot number and expiration date
Inactive Ingredients (Inactive ingredients)

anhydrous citric acid, flavors, non crystallizing sorbitol solution, propylene glycol, purified water, sodium benzoate and sucralose.

Questions?

call 1-888-588-1418

                                              

Distributed by:

Camber Consumer Care, Inc.

Piscataway, NJ 08854, USA.



Mfg. Lic. No.: 22/RR/AP/2001/F/R





Use(s) (USE(S))

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
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.

Active Ingredient(s) (ACTIVE INGREDIENT(S))

(in each 5 mL)

Cetirizine Hydrochloride USP 5mg



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
Cetirizine Hydrochloride (cetirizine hydrochloride)
Ask A Doctor Before Use If (ASK A DOCTOR BEFORE USE IF)

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

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 (1-800-222-1222).

Ask A Doctor Or Pharmacist Before Use If (ASK A DOCTOR OR PHARMACIST BEFORE USE IF)

you are taking tranquilizers or sedatives.

Advanced Ingredient Data

Raw Label Data

All Sections (JSON)

Additional Information

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Source: dailymed · Ingested: 2026-02-15T12:02:31.886762 · Updated: 2026-03-14T23:02:08.105317