Cetirizine and Pseudoephedrine: Package Insert / Prescribing Info
Package insert / product label
Generic name: cetirizine hydrochloride, pseudoephedrine hydrochloride
Dosage form: tablet, film coated, extended release
Drug class: Upper respiratory combinations
Medically reviewed by Drugs.com. Last updated on Mar 24, 2025.
Indications and Usage for Cetirizine and Pseudoephedrine
- 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.
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
Cetirizine and Pseudoephedrine Dosage and Administration
- 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 (for bottle only).
- DO NOT USE IF BLISTER UNIT IS BROKEN OR TORN (for blister package only).
Related/similar drugs
Promethazine
Promethazine is a phenothiazine and antihistamine used to treat allergies, motion sickness, nausea ...
Zyrtec
Zyrtec (cetirizine) is used to treat allergy symptoms such as sneezing, itching, watery eyes, or ...
Botox
Botox is used for cosmetic purposes and to treat overactive bladder symptoms, urinary incontinence ...
Dexamethasone
Dexamethasone is used to treat inflammatory conditions such as allergies, skin conditions ...
Triamcinolone nasal
Triamcinolone nasal is used for allergic rhinitis, allergies
Loratadine
Loratadine is a non-drowsy antihistamine used to relieve allergy symptoms like sneezing, runny ...
Methylprednisolone
Methylprednisolone is used to treat conditions such as allergies, arthritis, lupus and ulcerative ...
Montelukast
Montelukast is a daily oral medication used to prevent asthma attacks, exercise-induced ...
Cetirizine
Cetirizine treats cold or allergy symptoms such as sneezing, itching, watery eyes, or runny nose ...
Fluticasone nasal
Fluticasone nasal is used for allergic rhinitis, allergies, chronic rhinosinusitis with nasal ...
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.
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
5 mg/120 mg Blister Pack
Cetirizine HCl and
Pseudoephedrine
HCl Extended
Release Tablet
5 mg/120 mg
Sandoz Inc., Princeton, NJ 08540
5 mg/120 mg Blister Pack Carton
NDC 0781-5285-40
Cetirizine HCl and
Pseudoephedrine HCl
Extended Release Tablets
5 mg/120 mg
antihistamine/nasal decongestant
24 Tablets (4 x 6)
SANDOZ
ALLERGY &
CONGESTION
12 hour Relief of
Runny Nose
Itchy, Watery Eyes
Sinus Pressure
Sneezing
Itchy Throat or Nose
Nasal Congestion
Indoor &
Outdoor
Allergies
| CETIRIZINE HCL AND PSEUDOEPHEDRINE HCL
ER
cetirizine hcl and pseudoephedrine hcl tablet, film coated, extended release |
||||||||||||||||||||||||||||||
|
||||||||||||||||||||||||||||||
|
||||||||||||||||||||||||||||||
|
||||||||||||||||||||||||||||||
|
||||||||||||||||||||||||||||||
|
||||||||||||||||||||||||||||||
|
||||||||||||||||||||||||||||||
| Labeler - Sandoz Inc (110342024) |
| Establishment | |||
| Name | Address | ID/FEI | Business Operations |
|---|---|---|---|
| Sandoz Inc | 110342024 | MANUFACTURE | |
| Establishment | |||
| Name | Address | ID/FEI | Business Operations |
|---|---|---|---|
| Thermo-Pak, Inc | 161049044 | PACK, LABEL | |
More about cetirizine / pseudoephedrine
- Check interactions
- Compare alternatives
- Pricing & coupons
- Reviews (8)
- Drug images
- Side effects
- Dosage information
- During pregnancy
- Drug class: upper respiratory combinations
- En español
Patient resources
Professional resources
Other brands
Zyrtec-D 12 Hour, Allergy Relief D, Wal-Zyr D, All Day Allergy-D
