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NDC 51660-0066-30 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 OHM LABORATORIES 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: 51660-0066-30Last Updated: 11/30/2022
MedLinePlus Full Drug Details: Cetirizine
Product Information
| NDC | 51660-0066 |
|---|---|
| Product ID | 51660-066_1ae46a4b-8176-44fc-bc57-ed9e62c02746 |
| Associated GPIs | |
| GCN Sequence Number | n/a |
| GCN Sequence Number Description | n/a |
| HIC3 | n/a |
| HIC3 Description | n/a |
| GCN | n/a |
| HICL Sequence Number | n/a |
| HICL Sequence Number Description | n/a |
| Brand/Generic | n/a |
| 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 | OHM LABORATORIES INC. |
| Pharmaceutical Class | Histamine H1 Receptor Antagonists [MoA], Histamine-1 Receptor Antagonist [EPC] |
| DEA Schedule | n/a |
| Marketing Category | ANDA |
| Application Number | ANDA090142 |
| Listing Certified Through | 2024-12-31 |
Package
Package Images
NDC 51660-0066-30 (51660006630)
| NDC Package Code | 51660-066-30 |
|---|---|
| Billing NDC | 51660006630 |
| Package | 1 BOTTLE in 1 CARTON (51660-066-30) / 30 TABLET, CHEWABLE in 1 BOTTLE |
| Marketing Start Date | 2022-07-21 |
| NDC Exclude Flag | N |
| Pricing Information | N/A |
Standard Product Labeling (SPL)/Prescribing Information SPL 97802669-b4bd-4807-b3c1-6c6f5a2b0c67 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
- may be taken with or without water
- chew or crush tablets completely before swallowing
| adults and children 6 years and over | Chew and swallow 1 tablet (10 mg) once daily; do not take more than 1 tablet (10 mg) 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 |
Other information
Inactive ingredients
acesulfame potassium, colloidal silicon dioxide, compressible sugar, crospovidone, FD & C Blue No # 2 Aluminum Lake, FD & C Red No # 40 Aluminum Lake, guar gum, magnesium oxide light powder, magnesium stearate, mannitol, microcrystalline cellulose, pregelatinized starch, prosweet N & A flavor powder, talc, tutti frutti flavor
PRINCIPAL DISPLAY PANEL - 10 mg Tablet Bottle Carton
†Compare To
the active ingredient of
Children's Zyrtec®
NDC 51660-066-30
ohm®
Original Prescription Strength
Cetirizine
Hydrochloride
Chewable
Tablets 10 mg
Antihistamine
Allergy
Tutti-frutti Flavor
No Water Needed
Indoor + Outdoor Allergies
Actual Size
24 Hour Relief of:
- Sneezing
- Itchy, Watery Eyes
- Runny Nose
- Itchy Throat or Nose
30 CHEWABLE
TABLETS
INGREDIENTS AND APPEARANCE
| CETIRIZINE HYDROCHLORIDE
cetirizine hydrochloride tablet, chewable |
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| Labeler - OHM LABORATORIES INC. (184769029) |
| Establishment | |||
| Name | Address | ID/FEI | Business Operations |
|---|---|---|---|
| Sun Pharmaceutical Industries Limited | 725959238 | MANUFACTURE(51660-066) | |