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NDC 00363-0094-84 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 WALGREEN CO.. 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: 00363-0094-84Last Updated: 11/30/2022
MedLinePlus Full Drug Details: Fexofenadine and Pseudoephedrine
Product Information
| NDC | 00363-0094 |
|---|---|
| Product ID | 0363-0094_682cc322-962f-4526-bddf-698c77017c50 |
| Associated GPIs | |
| GCN Sequence Number | n/a |
| GCN Sequence Number Description | n/a |
| HIC3 | n/a |
| HIC3 Description | n/a |
| GCN | n/a |
| HICL Sequence Number | n/a |
| HICL Sequence Number Description | n/a |
| Brand/Generic | n/a |
| 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 | WALGREEN CO. |
| 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 | ANDA209116 |
| Listing Certified Through | 2024-12-31 |
Package
Package Images
NDC 00363-0094-84 (00363009484)
| NDC Package Code | 0363-0094-84 |
|---|---|
| Billing NDC | 00363009484 |
| Package | 3 BLISTER PACK in 1 CARTON (0363-0094-84) / 10 TABLET, FILM COATED, EXTENDED RELEASE in 1 BLISTER PACK |
| Marketing Start Date | 2017-10-30 |
| NDC Exclude Flag | N |
| Pricing Information | N/A |
Standard Product Labeling (SPL)/Prescribing Information SPL 1fcb601c-19d2-4db9-938b-b4f98ba9332f Details
Drug Facts
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
Warnings
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
- do not take more than directed
- do not take at the same time as aluminum or magnesium antacids
- do not take with fruit juices (see Directions)
- the tablet coating may be seen in the stool (this is normal). Continue to take as directed (see Directions).
Stop use and ask a 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
- safety sealed: do not use if carton is opened or if individual blister units are torn or opened.
- store at 20-25°C (68-77°F).
- Meets USP dissolution test 7
Inactive ingredients
colloidal silicon dioxide, croscarmellose sodium, ferric oxide yellow, hydroxypropyl cellulose, hypromellose, lactose monohydrate, microcrystalline cellulose, polyethylene glycol, pregelatinized starch (maize), stearic acid
Questions or Comments?
call 1-855-274-4122
IMPORTANT: Read the directions and warnings before use. Keep the carton, it contains important information.
DISTRIBUTED BY:
WALGREEN CO.
200 WILMOT RD., DEERFIELD, IL 60015
walgreens.com
©2021 Walgreen Co.
MADE IN INDIA
Code: TS/DRUGS/22/2009
PACKAGE LABEL-PRINCIPAL DISPLAY PANEL - 2 x 10 Blister Carton
Walgreens
Compare to the active ingredients in
Allegra-D® 12 Hour
Allergy & Congestion Tablets††
NDC 0363-0094-67
NON-DROWSY
Allergy Relief D12
ALLERGY & CONGESTION
Fexofenadine HCl USP 60 mg / Antihistamine
Pseudoephedrine HCl USP 120 mg / Nasal decongestant
12 Hour
Extended-Release Tablets USP
Indoor & Outdoor Allergies
- Nasal and sinus congestion due to colds or allergies
-
Relief of 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 - WALGREEN CO. (008965063) |
| Registrant - Aurohealth LLC (078728447) |
| Establishment | |||
| Name | Address | ID/FEI | Business Operations |
|---|---|---|---|
| Aurobindo Pharma Limited | 650381903 | ANALYSIS(0363-0094) , MANUFACTURE(0363-0094) | |