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NDC 68016-0023-43 Childrens Cetirizine Hydrochloride 5 mg/5mL Details
Childrens Cetirizine Hydrochloride 5 mg/5mL
Childrens Cetirizine Hydrochloride is a ORAL SOLUTION in the HUMAN OTC DRUG category. It is labeled and distributed by Chain Drug Consortium, LLC (Premier Value). 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: 68016-0023-43Last Updated: 12/01/2022
MedLinePlus Full Drug Details: Cetirizine
Product Information
| NDC | 68016-0023 |
|---|---|
| Product ID | 68016-023_c067a0f7-cadb-42cb-9bd4-6b901aec98c4 |
| Associated GPIs | |
| GCN Sequence Number | 058018 |
| GCN Sequence Number Description | calcium carbonate/vitamin D3 TABLET 600 MG-10 ORAL |
| HIC3 | C1F |
| HIC3 Description | CALCIUM REPLACEMENT |
| GCN | 23323 |
| HICL Sequence Number | 005859 |
| HICL Sequence Number Description | CALCIUM CARBONATE/CHOLECALCIFEROL (VITAMIN D3) |
| Brand/Generic | Generic |
| Proprietary Name | Childrens Cetirizine Hydrochloride |
| Proprietary Name Suffix | n/a |
| Non-Proprietary Name | Cetirizine Hydrochloride |
| Product Type | HUMAN OTC DRUG |
| Dosage Form | SOLUTION |
| Route | ORAL |
| Active Ingredient Strength | 5 |
| Active Ingredient Units | mg/5mL |
| Substance Name | CETIRIZINE HYDROCHLORIDE |
| Labeler Name | Chain Drug Consortium, LLC (Premier Value) |
| Pharmaceutical Class | Histamine H1 Receptor Antagonists [MoA], Histamine-1 Receptor Antagonist [EPC] |
| DEA Schedule | n/a |
| Marketing Category | ANDA |
| Application Number | ANDA090182 |
| Listing Certified Through | 2024-12-31 |
Package
Package Images
NDC 68016-0023-43 (68016002343)
| NDC Package Code | 68016-023-43 |
|---|---|
| Billing NDC | 68016002343 |
| Package | 1 BOTTLE in 1 CARTON (68016-023-43) / 120 mL in 1 BOTTLE |
| Marketing Start Date | 2008-04-22 |
| NDC Exclude Flag | N |
| Pricing Information | N/A |
Standard Product Labeling (SPL)/Prescribing Information SPL b47b0c8b-59d5-4e17-95be-a992c6861ee7 Details
Uses
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.
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.
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 older | 1 teaspoonful (5 mL) once daily; do not take more than 1 teaspoonful (5 mL) in 24 hours. |
| children 2 to under 6 years of age | 1/2 teaspoonful (2.5 mL) once daily. If needed, dose can be increased to a maximum of 1 teaspoonful (5 mL) once daily or 1/2 teaspoonful (2.5 mL) every 12 hours. Do not give more than 1 teaspoonful (5 mL) in 24 hours. |
| children under 2 years of age | ask a doctor |
| consumers with liver or kidney disease | ask a doctor |
Inactive ingredients
SPL UNCLASSIFIED SECTION
PRINCIPAL DISPLAY PANEL - 120 mL bottle carton
NDC 68016-023-43
Ages
two years
and older
Compare to
the active ingredient
in Children's Zyrtec®*
Premier
Value®
CHILDREN'S
CETIRIZINE
HYDROCHLORIDE
ORAL SOLUTION
1 mg/1 mL
Antihistamine
Grape Flavored Syrup
24 hour Allergy Relief of:
Sneezing; Runny Nose;
Itchy,Watery Eyes;
Itchy Throat or Nose
Indoor & Outdoor Allergies
Dosing Cup
Included
PV
PREMIER VALUE GUARANTEE
4 FL OZ (120 mL)
INGREDIENTS AND APPEARANCE
| CHILDRENS CETIRIZINE HYDROCHLORIDE
cetirizine hydrochloride solution |
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| Labeler - Chain Drug Consortium, LLC (Premier Value) (101668460) |
| Registrant - Taro Pharmaceuticals U.S.A., Inc. (145186370) |
| Establishment | |||
| Name | Address | ID/FEI | Business Operations |
|---|---|---|---|
| Taro Pharmaceutical Industries Ltd. | 600072078 | ANALYSIS(68016-023) , MANUFACTURE(68016-023) | |