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NDC 68094-0004-62 Dye Free Childrens Cetirizine Hydrocholride 5 mg/5mL Details
Dye Free Childrens Cetirizine Hydrocholride 5 mg/5mL
Dye Free Childrens Cetirizine Hydrocholride is a ORAL SOLUTION in the HUMAN OTC DRUG category. It is labeled and distributed by Precision Dose, Inc.. 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: 68094-0004-62Last Updated: 12/01/2022
MedLinePlus Full Drug Details: Cetirizine
Product Information
| NDC | 68094-0004 |
|---|---|
| Product ID | 68094-004_ad976192-fd11-49d6-84f5-b619a78ef3ab |
| Associated GPIs | 41550020102010 |
| GCN Sequence Number | 065685 |
| GCN Sequence Number Description | cetirizine HCl SOLUTION 5 MG/5 ML ORAL |
| HIC3 | Z2Q |
| HIC3 Description | ANTIHISTAMINES - 2ND GENERATION |
| GCN | 27714 |
| HICL Sequence Number | 006544 |
| HICL Sequence Number Description | CETIRIZINE HCL |
| Brand/Generic | Generic |
| Proprietary Name | Dye Free Childrens Cetirizine Hydrocholride |
| 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 | Precision Dose, Inc. |
| Pharmaceutical Class | Histamine H1 Receptor Antagonists [MoA], Histamine-1 Receptor Antagonist [EPC] |
| DEA Schedule | n/a |
| Marketing Category | ANDA |
| Application Number | ANDA204226 |
| Listing Certified Through | 2024-12-31 |
Package
Package Images
NDC 68094-0004-62 (68094000462)
| NDC Package Code | 68094-004-62 |
|---|---|
| Billing NDC | 68094000462 |
| Package | 3 TRAY in 1 CASE (68094-004-62) / 10 CUP, UNIT-DOSE in 1 TRAY / 5 mL in 1 CUP, UNIT-DOSE (68094-004-59) |
| Marketing Start Date | 2016-10-26 |
| NDC Exclude Flag | N |
| Pricing Information | N/A |
Standard Product Labeling (SPL)/Prescribing Information SPL 6a7c4dff-66c6-4d0c-af10-d908c65a43be 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 as directed per healthcare professional.
- mL = milliliter
| adults and children 6 years and over | 5 mL or 10 mL once daily depending upon severity of symptoms; do not take more than 10 mL in 24 hours. |
| adults 65 years and over | 5 mL once daily; do not take more than 5 mL in 24 hours. |
| children 2 to under 6 years of age | 2.5 mL once daily. If needed, dose can be increased to a maximum of 5 mL once daily or 2.5 mL every 12 hours. Do not give more than 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
Inactive ingredients
SPL UNCLASSIFIED SECTION
PRINCIPAL DISPLAY PANEL - 5 mL Cup Label
INGREDIENTS AND APPEARANCE
| DYE FREE CHILDRENS CETIRIZINE HYDROCHOLRIDE
cetirizine hydrochloride solution |
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| Labeler - Precision Dose, Inc. (035886746) |