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NDC 63187-0955-24 Cetirizine Hydrochloride and Pseudoephedrine Hydrochloride 5; 120 mg/1; mg/1 Details
Cetirizine Hydrochloride and Pseudoephedrine Hydrochloride 5; 120 mg/1; mg/1
Cetirizine Hydrochloride and Pseudoephedrine Hydrochloride is a ORAL TABLET, EXTENDED RELEASE in the HUMAN OTC DRUG category. It is labeled and distributed by Proficient Rx LP. The primary component is CETIRIZINE HYDROCHLORIDE; PSEUDOEPHEDRINE HYDROCHLORIDE.
MedlinePlus Drug Summary
Cetirizine is used to temporarily relieve the symptoms of hay fever (allergy to pollen, dust, or other substances in the air) and allergy to other substances (such as dust mites, animal dander, cockroaches, and molds). These symptoms include sneezing; runny nose; itchy, red, watery eyes; and itchy nose or throat. Cetirizine is also used to treat itching and redness caused by hives. However, cetirizine does not prevent hives or other allergic skin reactions. Cetirizine is in a class of medications called antihistamines. It works by blocking the action of histamine, a substance in the body that causes allergic symptoms. Cetirizine is also available in combination with pseudoephedrine (Sudafed, others). This monograph only includes information about the use of cetirizine alone. If you are taking the cetirizine and pseudoephedrine combination product, read the information on the package label or ask your doctor or pharmacist for more information.
Related Packages: 63187-0955-24Last Updated: 12/01/2022
MedLinePlus Full Drug Details: Cetirizine
Pseudoephedrine is used to relieve nasal congestion caused by colds, allergies, and hay fever. It is also used to temporarily relieve sinus congestion and pressure. Pseudoephedrine will relieve symptoms but will not treat the cause of the symptoms or speed recovery. Pseudoephedrine is in a class of medications called nasal decongestants. It works by causing narrowing of the blood vessels in the nasal passages.
Related Packages: 63187-0955-24Last Updated: 12/01/2022
MedLinePlus Full Drug Details: Pseudoephedrine
Product Information
| NDC | 63187-0955 |
|---|---|
| Product ID | 63187-955_0a08231c-188b-4c9a-8680-d43152d71983 |
| Associated GPIs | 43993002277420 |
| GCN Sequence Number | 048415 |
| GCN Sequence Number Description | cetirizine HCl/pseudoephedrine TAB ER 12H 5 MG-120MG ORAL |
| HIC3 | Z2O |
| HIC3 Description | 2ND GEN ANTIHISTAMINE AND DECONGESTANT COMBINATION |
| GCN | 13866 |
| HICL Sequence Number | 022864 |
| HICL Sequence Number Description | CETIRIZINE HCL/PSEUDOEPHEDRINE HCL |
| Brand/Generic | Generic |
| Proprietary Name | Cetirizine Hydrochloride and Pseudoephedrine Hydrochloride |
| Proprietary Name Suffix | n/a |
| Non-Proprietary Name | Cetirizine HCl, Pseudoephedrine HCl |
| Product Type | HUMAN OTC DRUG |
| Dosage Form | TABLET, EXTENDED RELEASE |
| Route | ORAL |
| Active Ingredient Strength | 5; 120 |
| Active Ingredient Units | mg/1; mg/1 |
| Substance Name | CETIRIZINE HYDROCHLORIDE; PSEUDOEPHEDRINE HYDROCHLORIDE |
| Labeler Name | Proficient Rx LP |
| Pharmaceutical Class | Adrenergic alpha-Agonists [MoA], Histamine H1 Receptor Antagonists [MoA], Histamine-1 Receptor Antagonist [EPC], alpha-Adrenergic Agonist [EPC] |
| DEA Schedule | n/a |
| Marketing Category | ANDA |
| Application Number | ANDA077170 |
| Listing Certified Through | 2024-12-31 |
Package
Package Images
NDC 63187-0955-24 (63187095524)
| NDC Package Code | 63187-955-24 |
|---|---|
| Billing NDC | 63187095524 |
| Package | 24 BLISTER PACK in 1 CARTON (63187-955-24) / 1 TABLET, EXTENDED RELEASE in 1 BLISTER PACK |
| Marketing Start Date | 2018-01-01 |
| NDC Exclude Flag | N |
| Pricing Information | N/A |
Standard Product Labeling (SPL)/Prescribing Information SPL 5d91286c-5650-462f-bd3d-f3b2387afcde Details
Uses
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- temporarily relieves these symptoms due to hay fever or other upper respiratory allergies:
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- runny nose
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- sneezing
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- itchy, watery eyes
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- itching of the nose or throat
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- nasal congestion
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- reduces swelling of nasal passages
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- temporarily relieves sinus congestion and pressure
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- 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
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- 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
Directions
Inactive ingredients
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:
Sneezing
Itchy, Watery Eyes
Runny Nose
Itchy Throat or Nose
Sinus Pressure
Nasal Congestion
actual size
Original Prescription Strength
Indoor & Outdoor Allergies
12 Extended Release Tablets
Allergy & Congestion
Relabeled by:
Proficient Rx LP
Thousand Oaks, CA 91320
INGREDIENTS AND APPEARANCE
| CETIRIZINE HYDROCHLORIDE AND PSEUDOEPHEDRINE HYDROCHLORIDE
cetirizine hcl, pseudoephedrine hcl tablet, extended release |
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| Labeler - Proficient Rx LP (079196022) |
| Establishment | |||
| Name | Address | ID/FEI | Business Operations |
|---|---|---|---|
| Proficient Rx LP | 079196022 | RELABEL(63187-955) | |