FDA Label for Childrens Cetirizine Hydrochloride Hives Relief
View Indications, Usage & Precautions
- ACTIVE INGREDIENT (IN EACH 5 ML)
- PURPOSE
- USES
- WARNINGS
- DO NOT USE
- ASK A DOCTOR BEFORE USE IF YOU HAVE
- ASK A DOCTOR OR PHARMACIST BEFORE USE IF YOU ARE
- WHEN USING THIS PRODUCT
- STOP USE AND ASK A DOCTOR IF
- IF PREGNANT OR BREAST-FEEDING:
- KEEP OUT OF REACH OF CHILDREN.
- DIRECTIONS
- OTHER INFORMATION
- INACTIVE INGREDIENTS
- QUESTIONS?
- PACKAGE LABEL-PRINCIPAL DISPLAY PANEL - 1 MG/ML (120 ML BOTTLE)
- PACKAGE LABEL-PRINCIPAL DISPLAY PANEL - 1 MG/ML CARTON (120 ML)
Childrens Cetirizine Hydrochloride Hives Relief Product Label
The following document was submitted to the FDA by the labeler of this product Aurohealth Llc. The document includes published materials associated whith this product with the essential scientific information about this product as well as other prescribing information. Product labels may durg indications and usage, generic names, contraindications, active ingredients, strength dosage, routes of administration, appearance, warnings, inactive ingredients, etc.
Active Ingredient (In Each 5 Ml)
Cetirizine hydrochloride USP 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 a 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
- If you have ever had an allergic reaction to this product or any of its ingredients or to an antihistamine containing hydroxyzine.
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.
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. (1-800-222-1222)
Directions
- use only with enclosed dosing cup
- find right dose on chart below
- mL = milliliter
| 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 20° to 25°C (68° to 77°F)
- Do not use if carton is opened, or if cap safety seal is broken or missing.
Inactive Ingredients
cherry mint flavor, glacial acetic acid, glycerin, methylparaben, propylene glycol, propylparaben, purified water, sodium acetate trihydrate, sucrose
Questions?
call 1-855-274-4122
Dosing cup should be washed and left to air dry after each use.
Do not use if carton is opened, or if cap safety seal is broken or missing.
Manufactured for:
AUROHEALTH LLC,
2572 Brunswick Pike,
Lawrenceville, NJ 08648
Manufactured by:
Aurobindo Pharma Limited
Hyderabad-500 090, India
M.L.No.: 19/HD/AP/95/F/R
Package Label-Principal Display Panel - 1 Mg/Ml (120 Ml Bottle)
AUROHEALTH
NDC 58602-030-24
Children's
Cetirizine Hydrochloride
Oral Solution USP
1 mg/mL
antihistamine HIVES
Relief
24 hour
Relief of
ITCHING
Due to Hives
6 yrs.
& older
Dye-Free
Cherry Flavor
4 fl oz (120 mL)
Package Label-Principal Display Panel - 1 Mg/Ml Carton (120 Ml)
AUROHEALTH
NDC 58602-030-24
Children's
Cetirizine Hydrochloride
Oral Solution USP
1 mg/mL
antihistamine HIVES
Relief
24 hour
Relief of
ITCHING
Due to Hives
6 yrs.
& older
Dye-Free
Cherry Flavor
4 fl oz (120 mL)
Dosing Cup Included
* Please review the disclaimer below.