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NDC 00781-5284-64 Cetirizine Hydrochloride 10 mg/1 Details
Cetirizine Hydrochloride 10 mg/1
Cetirizine Hydrochloride is a ORAL TABLET, CHEWABLE in the HUMAN OTC DRUG category. It is labeled and distributed by Sandoz 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: 00781-5284-64Last Updated: 11/30/2022
MedLinePlus Full Drug Details: Cetirizine
Product Information
| NDC | 00781-5284 |
|---|---|
| Product ID | 0781-5284_19a2fdfc-fc49-4226-8c8a-b428135ec4f7 |
| Associated GPIs | 41550020100520 |
| GCN Sequence Number | 053981 |
| GCN Sequence Number Description | cetirizine HCl TAB CHEW 10 MG ORAL |
| HIC3 | Z2Q |
| HIC3 Description | ANTIHISTAMINES - 2ND GENERATION |
| GCN | 21771 |
| HICL Sequence Number | 006544 |
| HICL Sequence Number Description | CETIRIZINE HCL |
| Brand/Generic | Generic |
| Proprietary Name | Cetirizine Hydrochloride |
| Proprietary Name Suffix | n/a |
| Non-Proprietary Name | Cetirizine Hydrochloride |
| Product Type | HUMAN OTC DRUG |
| Dosage Form | TABLET, CHEWABLE |
| Route | ORAL |
| Active Ingredient Strength | 10 |
| Active Ingredient Units | mg/1 |
| Substance Name | CETIRIZINE HYDROCHLORIDE |
| Labeler Name | Sandoz Inc |
| Pharmaceutical Class | Histamine H1 Receptor Antagonists [MoA], Histamine-1 Receptor Antagonist [EPC] |
| DEA Schedule | n/a |
| Marketing Category | ANDA |
| Application Number | ANDA078692 |
| Listing Certified Through | 2024-12-31 |
Package
Package Images
NDC 00781-5284-64 (00781528464)
| NDC Package Code | 0781-5284-64 |
|---|---|
| Billing NDC | 00781528464 |
| Package | 30 BLISTER PACK in 1 CARTON (0781-5284-64) / 1 TABLET, CHEWABLE in 1 BLISTER PACK (0781-5284-06) |
| Marketing Start Date | 2008-02-14 |
| NDC Exclude Flag | N |
| Pricing Information | |
| Price Per Unit | 2.52583 |
| Pricing Unit | EA |
| Effective Date | 2024-02-21 |
| NDC Description | CETIRIZINE HCL 10 MG CHEW TAB |
| Pharmacy Type Indicator | C/I |
| OTC | Y |
| Explanation Code | 1 |
| Classification for Rate Setting | G |
| As of Date | 2024-02-21 |
Standard Product Labeling (SPL)/Prescribing Information SPL a814a06b-96ed-4403-bbd7-fc1142988b50 Details
Keep Out of Reach of Children
Uses
Warnings
Do not use if you have ever had an allergic reactions 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.
Ask a doctor or pharmacist before use if you are taking tranquilizers or sedatives.
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.
If pregnant or breast-feeding:
- •
- if breast-feeding: not recommended
- •
- if pregnant: ask a health professional before use.
Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center right away.
Directions
- •
- may be taken with or without water
|
adults and children 6 years and over |
one 10 mg tablet once daily; do not take more than one 10 mg tablet in 24 hours. A 5 mg product may be appropriate for less severe symptoms. |
|
adults 65 years and over |
ask a doctor |
|
children under 6 years of age |
ask a doctor |
|
consumers with liver or kidney disease |
ask a doctor |
Inactive ingredients
acesulfame potassium, artificial flavors, benzyl alcohol, betadex, colloidal silicon dioxide, dl-alpha-tocopherol, ferric oxide red, ferric oxide yellow, lactose monohydrate, magnesium stearate, maltodextrin, microcrystalline cellulose, propylene glycol, talc and tutti frutti flavor
Questions? 1-800-525-8747
Manufactured in India by Sandoz Private Ltd.,
for Sandoz Inc., Princeton, NJ 08540
Rev.06/2014
Principal Display Panel
NDC 0781-5284-64
Children's
Cetirizine HCl Chewable Tablets
10 mg
antihistamine
Tutti Frutti Flavored
30 Tablets
Do not use if individual blister unit is open or torn
ALLERGY
Indoor & Outdoor Allergies
24 hour Relief of
- •
- Sneezing
- •
- Runny Nose
- •
- Itchy, Watery Eyes
- •
- Itchy Throat or Nose
6 yrs. and older 10 mg each
INGREDIENTS AND APPEARANCE
| CETIRIZINE HYDROCHLORIDE
cetirizine hydrochloride tablet, chewable |
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| Labeler - Sandoz Inc (005387188) |