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NDC 46122-0452-60 Fexofenadine Hydrochloride and Pseudoephedrine Hydrochloride 60; 120 mg/1; mg/1 Details
Fexofenadine Hydrochloride and Pseudoephedrine Hydrochloride 60; 120 mg/1; mg/1
Fexofenadine Hydrochloride and Pseudoephedrine Hydrochloride is a ORAL TABLET, FILM COATED, EXTENDED RELEASE in the HUMAN OTC DRUG category. It is labeled and distributed by AmeriSource Bergen. The primary component is FEXOFENADINE HYDROCHLORIDE; PSEUDOEPHEDRINE HYDROCHLORIDE.
MedlinePlus Drug Summary
The combination of fexofenadine and pseudoephedrine is used in adults and children 12 years of age and older to relieve the allergy symptoms of seasonal allergic rhinitis ('hay fever'), including runny nose; sneezing; congestion (stuffy nose); red, itchy, or watery eyes; or itching of the nose, throat, or roof of the mouth. Fexofenadine is in a class of medications called antihistamines. It works by blocking the effects of histamine, a substance in the body that causes allergy symptoms. Pseudoephedrine is in a class of medications called decongestants. It works by drying up the nasal passages.
Related Packages: 46122-0452-60Last Updated: 11/30/2022
MedLinePlus Full Drug Details: Fexofenadine and Pseudoephedrine
Product Information
| NDC | 46122-0452 |
|---|---|
| Product ID | 46122-452_e29de5ab-e8fe-4d85-99fa-f867dd10273c |
| Associated GPIs | 43993002687420 |
| GCN Sequence Number | 036868 |
| GCN Sequence Number Description | fexofenadine/pseudoephedrine TAB ER 12H 60MG-120MG ORAL |
| HIC3 | Z2O |
| HIC3 Description | 2ND GEN ANTIHISTAMINE AND DECONGESTANT COMBINATION |
| GCN | 63565 |
| HICL Sequence Number | 016846 |
| HICL Sequence Number Description | FEXOFENADINE HCL/PSEUDOEPHEDRINE HCL |
| Brand/Generic | Generic |
| Proprietary Name | Fexofenadine Hydrochloride and Pseudoephedrine Hydrochloride |
| Proprietary Name Suffix | n/a |
| Non-Proprietary Name | Fexofenadine Hydrochloride and Pseudoephedrine Hydrochloride |
| Product Type | HUMAN OTC DRUG |
| Dosage Form | TABLET, FILM COATED, EXTENDED RELEASE |
| Route | ORAL |
| Active Ingredient Strength | 60; 120 |
| Active Ingredient Units | mg/1; mg/1 |
| Substance Name | FEXOFENADINE HYDROCHLORIDE; PSEUDOEPHEDRINE HYDROCHLORIDE |
| Labeler Name | AmeriSource Bergen |
| 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 | ANDA090818 |
| Listing Certified Through | 2024-12-31 |
Package
Package Images
NDC 46122-0452-60 (46122045260)
| NDC Package Code | 46122-452-60 |
|---|---|
| Billing NDC | 46122045260 |
| Package | 1 BLISTER PACK in 1 CARTON (46122-452-60) / 20 TABLET, FILM COATED, EXTENDED RELEASE in 1 BLISTER PACK |
| Marketing Start Date | 2018-03-01 |
| NDC Exclude Flag | N |
| Pricing Information | N/A |
Standard Product Labeling (SPL)/Prescribing Information SPL c20f780c-562b-4eb6-940d-2973382118eb Details
Active ingredient(s)
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
- temporarily relieves nasal congestion due to the common cold, hay fever or other upper respiratory allergies
- 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 -
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. -
if you have difficulty swallowing
Ask a doctor before use if you have
When using this product
Stop use and ask doctor if
Keep out of reach of children
Directions
-
do not divide, crush, chew or dissolve the tablet; swallow tablet whole
| adults and children 12 years of age and over | take 1 tablet with a glass of water every 12 hours on an empty stomach; do not take more than 2 tablets in 24 hours |
| children under 12 years of age | do not use |
| adults 65 years of age and older | ask a doctor |
| consumers with kidney disease | ask a doctor |
Other information
Inactive ingredients
PRINCIPAL DISPLAY PANEL - 60 mg/120 mg Tablet Blister Pack Carton
GOOD
NEIGHBOR
PHARMACY®
Compare to Allegra-D® active ingredients**
NDC 46122-452-60
Original Prescription Strength
NON-DROWSY
12 HOUR
fexofenadine HCl 60 mg/antihistamine
pseudoephedrine HCl 120 mg/nasal decongestant
Extended-Release Tablets, USP
Indoor & Outdoor Allergies
Allergy & Congestion
Relief of:
- Nasal and Sinus Congestion Due to Colds or Allergies
-
Sneezing; Runny Nose; Itchy, Watery Eyes and Itchy Nose or
Throat Due to Allergies
20 Extended-Release Tablets
INGREDIENTS AND APPEARANCE
| FEXOFENADINE HYDROCHLORIDE AND PSEUDOEPHEDRINE HYDROCHLORIDE
fexofenadine hydrochloride and pseudoephedrine hydrochloride tablet, film coated, extended release |
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| Labeler - AmeriSource Bergen (007914906) |
| Establishment | |||
| Name | Address | ID/FEI | Business Operations |
|---|---|---|---|
| Sun Pharmaceutical Industries Limited | 650445203 | ANALYSIS(46122-452) , MANUFACTURE(46122-452) | |
Revised: 5/2018
Document Id: e29de5ab-e8fe-4d85-99fa-f867dd10273c
Set id: c20f780c-562b-4eb6-940d-2973382118eb
Version: 1
Effective Time: 20180531