Childrens Cetirizine Hydrochloride Hives Relief by Aurobindo Pharma Limited
Childrens Cetirizine Hydrochloride Hives Relief by
Drug Labeling and Warnings
Childrens Cetirizine Hydrochloride Hives Relief by is a Otc medication manufactured, distributed, or labeled by Aurobindo Pharma Limited. Drug facts, warnings, and ingredients follow.
Drug Details [pdf]
CHILDRENS CETIRIZINE HYDROCHLORIDE HIVES RELIEF - cetirizine hydrochloride solution
Aurobindo Pharma Limited
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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
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
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
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 |
Inactive ingredients
banana flavor, glacial acetic acid, glycerin, grape flavor, methylparaben, propylene glycol, propylparaben, purified water, sodium acetate, sucrose
Questions?
call 1-866-850-2876
Dosing cup should be washed and left to air dry after each use.
Do not use if the cap safety seal is broken or missing.
Manufactured for:
AUROHEALTH
6 Wheeling Road
Dayton, NJ 08810
Manufactured by:
Aurobindo Pharma Limited,
Hyderabad-500 072, India
M.L.No.: 19/HD/AP/95/F/R
PACKAGE LABEL-PRINCIPAL DISPLAY PANEL - 1 mg/mL (120 mL Bottle)
NDC: 65862-443-12
Children's
Cetirizine Hydrochloride
Oral Solution USP
1 mg/mL
antihistamine HIVES
Relief
24 hour
Relief of
ITCHING
6 yrs.
& older
Grape
Syrup
4 fl oz (120 mL)
AUROBINDO
PACKAGE LABEL-PRINCIPAL DISPLAY PANEL - 1 mg/mL Carton (120 mL)
NDC: 65862-443-12
Children's
Cetirizine Hydrochloride
Oral Solution USP
1 mg/mL
antihistamine HIVES
Relief
24 hour
Relief of
ITCHING
6 yrs.
& older
Grape
Syrup
4 fl oz (120 mL)
AUROBINDO
| CHILDRENS CETIRIZINE HYDROCHLORIDE HIVES RELIEF
cetirizine hydrochloride solution |
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| Labeler - Aurobindo Pharma Limited (650082092) |
| Establishment | |||
| Name | Address | ID/FEI | Business Operations |
|---|---|---|---|
| Aurobindo Pharma Limited | 918917642 | ANALYSIS(65862-443) , MANUFACTURE(65862-443) | |