RxNorm Names
Review RxNorm Normal Forms
CETIRIZINE HYDROCHLORIDE tablet
[Topco Associates LLC]
Permanent Link:
http://dailymed.nlm.nih.gov/dailymed/lookup.cfm?setid=d4e6559d-882a-46dd-a735-f5bb5cd22885| Category | DEA Schedule | Marketing Status |
|---|---|---|
| HUMAN OTC DRUG LABEL | Abbreviated New Drug Application |
USES
Temporarily relieves these symptoms due to hay fever or other upper respiratory allergies:
- runny nose
- sneezing
- itchy, watery eyes
- itching of the nose or throat
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 | 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 |
OTHER INFORMATION
- TAMPER EVIDENT: DO NOT USE IF BLISTER UNITS ARE TORN, BROKEN OR SHOW ANY SIGNS OF TAMPERING.
- store between 20° to 25° C (68° to 77° F)
INACTIVE INGREDIENTS
Corn starch, hypromellose, lactose monohydrate, magnesium stearate, polyethylene glycol, povidone, talc, titanium dioxide
| CETIRIZINE HYDROCHLORIDE
cetirizine hydrochloride tablet |
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| Labeler - Topco Associates LLC (006935977) |
| Registrant - Ranbaxy Pharmaceuticals Inc. (937890044) |
| Establishment | |||
| Name | Address | ID/FEI | Business Operations |
| Ohm Laboratories Inc. | 184769029 | manufacture(36800-244) | |
Revised: 11/2012
Document Id: 9b26e69e-dccf-4dce-960a-61a127a951ad
Set id: d4e6559d-882a-46dd-a735-f5bb5cd22885
Version: 1
Effective Time: 20121129
Topco Associates LLC
