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NDC 00378-3637-05 Cetirizine Hydrochloride 10 mg/1 Details
Cetirizine Hydrochloride 10 mg/1
Cetirizine Hydrochloride is a ORAL TABLET, FILM COATED in the HUMAN OTC DRUG category. It is labeled and distributed by Mylan Pharmaceuticals 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: 00378-3637-05Last Updated: 11/30/2022
MedLinePlus Full Drug Details: Cetirizine
Product Information
| NDC | 00378-3637 |
|---|---|
| Product ID | 0378-3637_5670c6c3-a4ab-4268-917a-99e0579f3079 |
| Associated GPIs | 41550020100320 |
| GCN Sequence Number | 017037 |
| GCN Sequence Number Description | cetirizine HCl TABLET 10 MG ORAL |
| HIC3 | Z2Q |
| HIC3 Description | ANTIHISTAMINES - 2ND GENERATION |
| GCN | 49291 |
| 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, FILM COATED |
| Route | ORAL |
| Active Ingredient Strength | 10 |
| Active Ingredient Units | mg/1 |
| Substance Name | CETIRIZINE HYDROCHLORIDE |
| Labeler Name | Mylan Pharmaceuticals Inc. |
| Pharmaceutical Class | Histamine H1 Receptor Antagonists [MoA], Histamine-1 Receptor Antagonist [EPC] |
| DEA Schedule | n/a |
| Marketing Category | ANDA |
| Application Number | ANDA076677 |
| Listing Certified Through | 2024-12-31 |
Package
Package Images
NDC 00378-3637-05 (00378363705)
| NDC Package Code | 0378-3637-05 |
|---|---|
| Billing NDC | 00378363705 |
| Package | 500 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (0378-3637-05) |
| Marketing Start Date | 2007-12-27 |
| NDC Exclude Flag | N |
| Pricing Information | |
| Price Per Unit | 0.06399 |
| Pricing Unit | EA |
| Effective Date | 2024-02-21 |
| NDC Description | CETIRIZINE HCL 10 MG TABLET |
| 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 487ae0f0-320c-4534-b9e2-0e215f167cea 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
|
adults and children 6 years and over |
1 to 2 tablets once daily depending upon severity of symptoms; do not take more than 2 tablets in 24 hours. |
|
adults 65 years and over |
1 tablet once a day; do not take more than 1 tablet in 24 hours |
|
children under 6 years of age |
ask a doctor |
|
consumers with liver or kidney disease |
ask a doctor |
Inactive ingredients
Questions?
PRINCIPAL DISPLAY PANEL
PRINCIPAL DISPLAY PANEL - 5 mg Allergy
NDC 0378-3635-01
Cetirizine HCl
Tablets, USP
Allergy
5 mg
Antihistamine
Indoor & Outdoor Allergies
24 Hour Relief of
- •
- runny nose
- •
- sneezing
- •
- itchy, watery eyes
- •
- itching of the nose or throat
RMX-AR3635A 100 Tablets
Tamper Evident: do not use if foil seal
under cap is missing, open or broken.
PRINCIPAL DISPLAY PANEL
PRINCIPAL DISPLAY PANEL - 10 mg Allergy
NDC 0378-3637-01
Cetirizine HCl
Tablets, USP
Allergy
10 mg
Antihistamine
Indoor & Outdoor Allergies
24 Hour Relief of
- •
- runny nose
- •
- sneezing
- •
- itchy, watery eyes
- •
- itching of the nose or throat
RMX-AR3637A 100 Tablets
Tamper Evident: do not use if foil seal
under cap is missing, open or broken.
Active Ingredient (in each tablet)
Cetirizine hydrochloride USP, 10 mg
|
Directions | |
|
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 |
INGREDIENTS AND APPEARANCE
| CETIRIZINE HYDROCHLORIDE
cetirizine hydrochloride tablet, film coated |
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| CETIRIZINE HYDROCHLORIDE
cetirizine hydrochloride tablet, film coated |
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| Labeler - Mylan Pharmaceuticals Inc. (059295980) |