CETIRIZINE HCL AND PSEUDOEPHEDRINE HCL ER
-
cetirizine hydrochloride and
pseudoephedrine hydrochloride tablet, film coated, extended release
Sandoz Inc
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Drug FactsActive Ingredient (in each extended release tablet)
Cetirizine HCl 5 mg
Pseudoephedrine HCl 120 mg
Purpose
Antihistamine
Nasal decongestant
Uses
- temporarily relieves these symptoms due to hay fever or other upper respiratory allergies:
- runny nose
- itchy, watery eyes
- nasal congestion
- sneezing
- itching of the nose or throat
- reduces swelling of nasal passages
- temporarily relieves sinus congestion and pressure
- temporarily restores freer breathing through the nose
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.
- if you are now taking a prescription monoamine oxidase inhibitor (MAOI) (certain drugs for depression, psychiatric, or emotional conditions, or Parkinson’s disease), or for 2 weeks after stopping the MAOI drug. If you do not know if your prescription drug contains an MAOI, ask a doctor or pharmacist before taking this product.
Ask a doctor before use if you have
- heart disease
- thyroid disease
- diabetes
- glaucoma
- high blood pressure
- trouble urinating due to an enlarged prostate gland
- 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
- do not use more than directed
- 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.
- you get nervous, dizzy, or sleepless
- symptoms do not improve within 7 days or are accompanied by fever
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
- do not break or chew tablet; swallow tablet whole
| adults and children 12 years and over | take 1 tablet every 12 hours; do not take more than 2 tablets in 24 hours. |
| adults 65 years and over | ask a doctor |
| children under 12 years of age | ask a doctor |
| consumers with liver or kidney disease | ask a doctor |
Other Information
- Safety sealed: do not use if the imprinted bottle seal is open or torn.
Store at 20°-25°C (68°-77°F) (see USP Controlled Room Temperature).
Inactive Ingredients
Colloidal silicon dioxide, croscarmellose sodium, D & C yellow aluminum lake, hypromellose, iron oxide red, iron oxide yellow, lactose monohydrate, magnesium stearate, microcrystalline cellulose, polyethylene glycol, polysorbate, povidone, and titanium dioxide.
Questions or comments?
1-800-525-8747
Sandoz Inc.
Princeton, NJ 08540
07-2008M
5 mg/120 mg Label
NDC 0781-5285-31
Cetirizine HCl and
Pseudoephedrine HCl
Extended Release Tablets
5 mg/120 mg
antihistamine/
nasal decongestant
Indoor & Outdoor Allergies
ALLERGY & CONGESTION
12 hour Relief of
• Runny Nose • Itchy, Watery Eyes • Sinus Pressure
• Sneezing • Itchy Throat or Nose • Nasal Congestion
Sandoz
30 Tablets
| CETIRIZINE HCL AND PSEUDOEPHEDRINE HCL
ER
cetirizine hcl and pseudoephedrine hcl tablet, film coated, extended release |
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| Marketing Information | |||
| Marketing Category | Application Number or Monograph Citation | Marketing Start Date | Marketing End Date |
| ANDA | ANDA077991 | 03/05/2008 | |
| Labeler - Sandoz Inc (110342024) |
| Establishment | |||
| Name | Address | ID/FEI | Operations |
| Sandoz Inc | 110342024 | MANUFACTURE | |