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NDC 36800-0475-26 TopCare Childrens All Day Allergy 5 mg/5mL Details
TopCare Childrens All Day Allergy 5 mg/5mL
TopCare Childrens All Day Allergy is a ORAL SOLUTION in the HUMAN OTC DRUG category. It is labeled and distributed by Topco Associates 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: 36800-0475-26Last Updated: 11/30/2022
MedLinePlus Full Drug Details: Cetirizine
Product Information
| NDC | 36800-0475 |
|---|---|
| Product ID | 36800-475_97317935-9b54-4d2b-a5dc-601ab859edbb |
| Associated GPIs | 41550020102010 |
| GCN Sequence Number | 021687 |
| GCN Sequence Number Description | cetirizine HCl SOLUTION 1 MG/ML ORAL |
| HIC3 | Z2Q |
| HIC3 Description | ANTIHISTAMINES - 2ND GENERATION |
| GCN | 49290 |
| HICL Sequence Number | 006544 |
| HICL Sequence Number Description | CETIRIZINE HCL |
| Brand/Generic | Generic |
| Proprietary Name | TopCare Childrens All Day Allergy |
| Proprietary Name Suffix | n/a |
| Non-Proprietary Name | Cetirizine HCl |
| 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 | Topco Associates LLC |
| 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 36800-0475-26 (36800047526)
| NDC Package Code | 36800-475-26 |
|---|---|
| Billing NDC | 36800047526 |
| Package | 1 BOTTLE in 1 CARTON (36800-475-26) / 118 mL in 1 BOTTLE |
| Marketing Start Date | 2016-02-02 |
| NDC Exclude Flag | N |
| Pricing Information | N/A |
Standard Product Labeling (SPL)/Prescribing Information SPL 48555c1f-8c2a-4ab2-9af3-d2488ca509e4 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
- •
- find right dose on chart below
- •
- 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
Package/Label Principal Display Panel
50% MORE FREE
TopCare® health
COMPARE TO CHILDREN’S ZYRTEC® ACTIVE INGREDIENT
children’s
All-Day Allergy
CETIRIZINE HYDROCHLORIDE ORAL SOLUTION 1 mg/mL
ANTIHISTAMINE
INDOOR & OUTDOOR ALLERGIES
24 HOUR
RELIEF OF:
● Sneezing
● Runny Nose
● Itchy, Watery Eyes
● Itchy Throat or Nose
Dye Free & Sugar Free
2 Years & older
GRAPE FLAVOR
4 + 4 FL OZ (120 mL) =
8 FL OZ (240 mL)
Dosing cup included
INGREDIENTS AND APPEARANCE
| TOPCARE CHILDRENS ALL DAY ALLERGY
cetirizine hcl solution |
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| Labeler - Topco Associates LLC (006935977) |