CETIRIZINE HYDROCHLORIDE- cetirizine hydrochloride solution 
Preferred Pharmaceuticals Inc.

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Cetirizine Hydrochloride Oral Solution - Allergy

Drug Facts

Active ingredient (in each 5 mL (teaspoonful(tsp)): Cetirizine HCl 5 mg

Purpose: Antihistamine

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

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

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.

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.(1-800-222-1222)

Directions

use only with enclosed dosing cup

 adults and children 6 years and over

 1 teaspoonful (tsp)(5 mL) or 2 teaspoonfuls (tsp)(10 mL) once daily depending upon severity of symptoms; do not take more than 2 teaspoonfuls (tsp)(10 mL) in 24 hours.

 adults 65 years and over

 1 teaspoonful (tsp)(5 mL) once daily; do not take more than 1 teaspoonful (tsp)(5 mL) in 24 hours.

 children 2 to under 6 years of age

 1/2 teaspoonful (tsp)(2.5 mL) once daily. If needed, dose can be increased to a maximum of 1 teaspoonful (tsp)(5 mL) once daily or 1/2 teaspoonful (tsp)(2.5 mL) every 12 hours. Do not give more than 1 teaspoonful (tsp)(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 20º to 25ºC (68º to 77ºF)

Inactive ingredients

calcium acetate, grape flavor, glacial acetic acid, glycerin, methylparaben, propylene glycol, propylparaben, purified water.

Questions?

Call 1-888-974-5279

Cetirizine Hydrochloride Oral Solution - Hives Relief

Drug Facts

Active ingredient (in each 5 mL (teaspoonful)): Cetirizine HCl 5 mg

Purpose: Antihistamine

Uses

relieves itching due to hives (urticaria). This product will not prevent hives or an allergic skin reaction from occurring.

Warnings

Severe Allergy Warning: Get emergency help immediately if you have hives along with any of the following symptoms:

trouble swallowing
dizziness or loss of consciousness
swelling of tongue
swelling in or around mouth
trouble speaking
drooling
wheezing or problems breathing

These symptoms may be signs of anaphylactic shock. This condition can be life threatening if not treated by health professional immediately. Symptoms of anaphylactic shock may occur when hives first appear or up to a few hours later.
Not a Substitute for Epinephrine. If your doctor has prescribed an epinephrine injector for “anaphylaxis” or severe allergy symptoms that could occur with your hives, never use this product as a substitute for the epinephrine injector. If you have been prescribed an epinephrine injector, you should carry it with you at all times.

Do not use

to prevent hives from any known cause such as:
foods
insect stings
medicines
latex or rubber gloves because this product will not stop hives from occurring. Avoiding the cause of your hives is the only way to prevent them. Hives can sometimes be serious. If you do not know the cause of your hives, see your doctor for a medical exam. Your doctor may be able to help you find a cause.
if you have ever had an allergic reaction to this product or any of its ingredients or to an antihistamine containing hydroxyzine.

Ask a doctor before use if you have

liver or kidney disease. Your doctor should determine if you need a different dose
hives that are an unusual color, look bruised or blistered
hives that do not itch

Ask a doctor or pharmacist before use if you are

taking tranquilizers or sedatives

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.
symptoms do not improve after 3 days of treatment
the hives have lasted more than 6 weeks

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.

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 under 6 years of age

 ask a doctor

 consumers with liver or kidney disease

 ask a doctor

Other information
Store between 20º to 25ºC (68º to 77ºF)

Inactive ingredients

calcium acetate, grape flavor, glacial acetic acid, glycerin, methylparaben, propylene glycol, propylparaben, purified water

Questions?

Call 1-888-974-5279

Dosing Cup Included

Dosing cup should be washed and left to air dry after each use.

Do not use if carton is open; or if safety seal printed with “SEALED FOR YOUR PROTECTION” around cap of the bottle is broken or missing.

SAVE THIS CARTON FOR FULL LABELING INFORMATION

Relabeled By: Preferred Pharmaceuticals Inc.

NDC 68788-7585-1

Relabeled By: Preferred Pharmaceuticals Inc.

NDC 68788-7585-1

Cetirizine HCl Oral Soln 1mg/mL
CETIRIZINE HYDROCHLORIDE 
cetirizine hydrochloride solution
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:68788-7585(NDC:54838-552)
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
CETIRIZINE HYDROCHLORIDE (UNII: 64O047KTOA) (CETIRIZINE - UNII:YO7261ME24) CETIRIZINE HYDROCHLORIDE5 mg  in 5 mL
Inactive Ingredients
Ingredient NameStrength
CALCIUM ACETATE (UNII: Y882YXF34X)  
ACETIC ACID (UNII: Q40Q9N063P)  
GLYCERIN (UNII: PDC6A3C0OX)  
METHYLPARABEN (UNII: A2I8C7HI9T)  
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
PROPYLPARABEN (UNII: Z8IX2SC1OH)  
WATER (UNII: 059QF0KO0R)  
Product Characteristics
Color    Score    
ShapeSize
FlavorGRAPE (Grape Flavor) Imprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:68788-7585-1120 mL in 1 CARTON; Type 0: Not a Combination Product02/18/202011/29/2023
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
ANDAANDA09113002/18/202011/29/2023
Labeler - Preferred Pharmaceuticals Inc. (791119022)
Registrant - Preferred Pharmaceuticals Inc. (791119022)
Establishment
NameAddressID/FEIBusiness Operations
Preferred Pharmaceuticals Inc.791119022RELABEL(68788-7585)

Revised: 4/2023
 
Preferred Pharmaceuticals Inc.