Label: CETIRIZINE HYDROCHLORIDE AND PSEUDOEPHEDRINE HYDROCHLORIDE- cetirizine hydrochloride and pseudoephedrine hydrochloride tablet, extended release
- NDC Code(s): 45802-721-53, 45802-721-62
- Packager: Perrigo New York Inc
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: Abbreviated New Drug Application
NOTE: Most over the counter (OTC) are not reviewed and approved by the FDA. However, they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.
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- Active ingredients (in each extended release tablet)
Cetirizine HCl 5 mg
Pseudoephedrine HCl 120 mgClose
- temporarily relieves these symptoms due to hay fever or other upper respiratory allergies:
- runny nose
- 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
- 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
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.
- 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 oxideClose
- Questions or comments?
- Principal Display Panel
Compare to Zyrtec-D® active ingredients
Cetirizine Hydrochloride and Pseudoephedrine Hydrochloride
Extended Release Tablets
5 mg/120 mg
Antihistamine / Nasal Decongestant
12 Hour Relief of:
Itchy, Watery Eyes
Itchy Throat or Nose
Original Prescription Strength
Indoor & Outdoor Allergies
12 Extended Release Tablets
Allergy & CongestionClose
- INGREDIENTS AND APPEARANCE
CETIRIZINE HYDROCHLORIDE AND PSEUDOEPHEDRINE HYDROCHLORIDE
cetirizine hcl, pseudoephedrine hcl tablet, extended release
Product Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:45802-721 Route of Administration ORAL DEA Schedule Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength CETIRIZINE HYDROCHLORIDE (UNII: 64O047KTOA) (CETIRIZINE - UNII:YO7261ME24) CETIRIZINE HYDROCHLORIDE 5 mg PSEUDOEPHEDRINE HYDROCHLORIDE (UNII: 6V9V2RYJ8N) (PSEUDOEPHEDRINE - UNII:7CUC9DDI9F) PSEUDOEPHEDRINE HYDROCHLORIDE 120 mg Inactive Ingredients Ingredient Name Strength SILICON DIOXIDE (UNII: ETJ7Z6XBU4) HYDROXYPROPYL CELLULOSE (TYPE H) (UNII: RFW2ET671P) HYPROMELLOSES (UNII: 3NXW29V3WO) LACTOSE MONOHYDRATE (UNII: EWQ57Q8I5X) MAGNESIUM STEARATE (UNII: 70097M6I30) CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U) TALC (UNII: 7SEV7J4R1U) FERRIC OXIDE YELLOW (UNII: EX438O2MRT) Product Characteristics Color WHITE (one side white one side light yellow) Score no score Shape ROUND Size 12mm Flavor Imprint Code 5029;5;120 Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:45802-721-62 24 in 1 CARTON 1 1 in 1 BLISTER PACK 2 NDC:45802-721-53 12 in 1 CARTON 2 1 in 1 BLISTER PACK Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date ANDA ANDA077170 04/10/2008 Labeler - Perrigo New York Inc (078846912)