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NDC 58602-0030-20 Childrens Cetirizine Hydrochloride Hives Relief 1 mg/mL Details
Childrens Cetirizine Hydrochloride Hives Relief 1 mg/mL
Childrens Cetirizine Hydrochloride Hives Relief is a ORAL SOLUTION in the HUMAN OTC DRUG category. It is labeled and distributed by Aurohealth LLC. The primary component is CETIRIZINE HYDROCHLORIDE.
MedlinePlus Drug Summary
Cetirizine is used to temporarily relieve the symptoms of hay fever (allergy to pollen, dust, or other substances in the air) and allergy to other substances (such as dust mites, animal dander, cockroaches, and molds). These symptoms include sneezing; runny nose; itchy, red, watery eyes; and itchy nose or throat. Cetirizine is also used to treat itching and redness caused by hives. However, cetirizine does not prevent hives or other allergic skin reactions. Cetirizine is in a class of medications called antihistamines. It works by blocking the action of histamine, a substance in the body that causes allergic symptoms. Cetirizine is also available in combination with pseudoephedrine (Sudafed, others). This monograph only includes information about the use of cetirizine alone. If you are taking the cetirizine and pseudoephedrine combination product, read the information on the package label or ask your doctor or pharmacist for more information.
Related Packages: 58602-0030-20Last Updated: 12/01/2022
MedLinePlus Full Drug Details: Cetirizine
Product Information
| NDC | 58602-0030 |
|---|---|
| Product ID | 58602-030_d46defa2-560d-44bb-8b5b-423ab7d32e52 |
| Associated GPIs | |
| GCN Sequence Number | n/a |
| GCN Sequence Number Description | n/a |
| HIC3 | n/a |
| HIC3 Description | n/a |
| GCN | n/a |
| HICL Sequence Number | n/a |
| HICL Sequence Number Description | n/a |
| Brand/Generic | n/a |
| Proprietary Name | Childrens Cetirizine Hydrochloride Hives Relief |
| Proprietary Name Suffix | n/a |
| Non-Proprietary Name | Cetirizine Hydrochloride |
| Product Type | HUMAN OTC DRUG |
| Dosage Form | SOLUTION |
| Route | ORAL |
| Active Ingredient Strength | 1 |
| Active Ingredient Units | mg/mL |
| Substance Name | CETIRIZINE HYDROCHLORIDE |
| Labeler Name | Aurohealth LLC |
| Pharmaceutical Class | Histamine H1 Receptor Antagonists [MoA], Histamine-1 Receptor Antagonist [EPC] |
| DEA Schedule | n/a |
| Marketing Category | ANDA |
| Application Number | ANDA090750 |
| Listing Certified Through | 2024-12-31 |
Package
Package Images
NDC 58602-0030-20 (58602003020)
| NDC Package Code | 58602-030-20 |
|---|---|
| Billing NDC | 58602003020 |
| Package | 1 BOTTLE in 1 CARTON (58602-030-20) / 240 mL in 1 BOTTLE |
| Marketing Start Date | 2015-06-24 |
| NDC Exclude Flag | N |
| Pricing Information | N/A |
Standard Product Labeling (SPL)/Prescribing Information SPL e000848a-8bbe-4149-bdcb-d7b4b0bd4d0d Details
Uses
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
- 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
Inactive ingredients
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)
PACKAGE LABEL-PRINCIPAL DISPLAY PANEL - 1 mg/mL Carton (120 mL)
INGREDIENTS AND APPEARANCE
| CHILDRENS CETIRIZINE HYDROCHLORIDE HIVES RELIEF
cetirizine hydrochloride solution |
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| Labeler - Aurohealth LLC (078728447) |
| Establishment | |||
| Name | Address | ID/FEI | Business Operations |
|---|---|---|---|
| Aurobindo Pharma Limited | 918917642 | ANALYSIS(58602-030) , MANUFACTURE(58602-030) | |