Active Ingredient (In Each Extended Release Tablet)
Cetirizine HCl 5 mg
Pseudoephedrine HCl 120 mg
Cetirizine Hydrochloride And Pseudoephedrine Hydrochloride
FDA Label NDC 68258-8907
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Dispensing Solutions, Inc. for the product Cetirizine Hydrochloride And Pseudoephedrine Hydrochloride (NDC 68258-8907). This document serves as the official prescribing information, containing essential scientific data and clinical materials required for healthcare providers and patients.
This specific version of the label includes detailed information regarding active ingredient (in each extended release tablet), purpose, uses, do not use, ask a doctor before use if you have, ask a doctor or pharmacist before use if you are, when using this product, stop use and ask a doctor if, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Purpose
Antihistamine
Nasal Decongestant
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
- nasal congestion
- reduces swelling of nasal passages
- temporarily relieves sinus congestion and pressure
- temporarily restores freer breathing through the nose
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
- store between 20° to 25°C (68° to 77°F)
Inactive Ingredients
colloidal silicon dioxide, hydroxypropyl cellulose, hypromellose, lactose monohydrate, magnesium stearate, microcrystalline cellulose, talc, yellow iron oxide
Questions Or Comments?
1-800-719-9260
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Compare to Zyrtec-D® active ingredients
Original Prescription Strength
Cetirizine Hydrochloride and
Pseudoephedrine Hydrochloride
Extended Release Tablets, 5mg/120mg
Antihistamine/Nasal Decongestant
Allergy & Congestion
12 Hour Relief of:
Sneezing
Itchy, Watery Eyes
Runny Nose
Itchy Throat or Nose
Sinus Pressure
Nasal Congestion
Indoor & Outdoor Allergies
Actual Size
NDC 68258-8907-02
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