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NDC 63868-0430-04 Childrens Allergy 5 mg/5mL Details
Childrens Allergy 5 mg/5mL
Childrens Allergy is a ORAL LIQUID in the HUMAN OTC DRUG category. It is labeled and distributed by QUALITY CHOICE (Chain Drug Marketing Association). 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: 63868-0430-04Last Updated: 12/01/2022
MedLinePlus Full Drug Details: Cetirizine
Product Information
| NDC | 63868-0430 |
|---|---|
| Product ID | 63868-430_16b17be2-f5bc-48bd-a5a0-91e22a6de261 |
| 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 | Childrens Allergy |
| Proprietary Name Suffix | n/a |
| Non-Proprietary Name | Cetirizine HCl |
| Product Type | HUMAN OTC DRUG |
| Dosage Form | LIQUID |
| Route | ORAL |
| Active Ingredient Strength | 5 |
| Active Ingredient Units | mg/5mL |
| Substance Name | CETIRIZINE HYDROCHLORIDE |
| Labeler Name | QUALITY CHOICE (Chain Drug Marketing Association) |
| Pharmaceutical Class | Histamine H1 Receptor Antagonists [MoA], Histamine-1 Receptor Antagonist [EPC] |
| DEA Schedule | n/a |
| Marketing Category | ANDA |
| Application Number | ANDA090474 |
| Listing Certified Through | n/a |
Package
Package Images
NDC 63868-0430-04 (63868043004)
| NDC Package Code | 63868-430-04 |
|---|---|
| Billing NDC | 63868043004 |
| Package | 1 BOTTLE, PLASTIC in 1 BOX (63868-430-04) / 118 mL in 1 BOTTLE, PLASTIC |
| Marketing Start Date | 2014-12-31 |
| NDC Exclude Flag | N |
| Pricing Information | |
| Price Per Unit | 0.03794 |
| Pricing Unit | ML |
| Effective Date | 2022-08-17 |
| NDC Description | QC CHILDREN'S ALLERGY 1 MG/ML |
| Pharmacy Type Indicator | C/I |
| OTC | Y |
| Explanation Code | 1, 5 |
| Classification for Rate Setting | G |
| As of Date | 2022-08-17 |
Standard Product Labeling (SPL)/Prescribing Information SPL b82af836-fd04-4cfe-9fae-84b1ee152663 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
- alcohol, sedatives, and tranquilizers may increase drowsiness
- avoid alcoholic drinks
- 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 over | 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 dailly. 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
Principal Display Panel
*Compare to the active ingredient in Children's Zyrtec®
Children's Allergy
Indoor & Outdoor Allergies
Cetirizine Oral Solution
1mg/mL | Antihistamine
24-Hour relief of:
Sneezing
Runny nose
Itchy, watery eyes
Itchy throat or nose
For Ages 2 Years & Older
Dye-free
Grape Flavor
Dosing Cup Included
FL OZ (mL)
*This product is not manufactured or distributed by McNeil Consumer Healthcare, distributor of Children's Zyrtec®
TAMPER EVIDENT: DO NOT USE IF CARTON IS OPENED OR IF PRINTED SAFETY SEAL UNDER CAP IS BROKEN OR MISSING.
Dosing cup should be washed and left to air dry after each use
Distributed by C.D.M.A Inc.
43157 W. Nine Mile
Novi, MI 48376-0995
INGREDIENTS AND APPEARANCE
| CHILDRENS ALLERGY
cetirizine hcl liquid |
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| Labeler - QUALITY CHOICE (Chain Drug Marketing Association) (011920774) |